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DR54.1 DataRelease

Release Date: January 2025
New Studies: 18
Updated Studies: 30

New Studies

SDY2842: Site-specific development and progressive maturation of human tissue-resident memory T cells over infancy and childhood
Status: New
Description: Infancy and childhood are critical life stages for generating immune memory to protect against pathogens; however, the timing, location, and pathways for memory development in humans remain elusive. Here, we investigated T cells in mucosal sites, lymphoid tissues, and blood from 96 pediatric donors aged 0-10 years using phenotypic, functional, and transcriptomic profiling. Our results revealed that memory T cells preferentially localized in the intestines and lungs during infancy and accumulated more rapidly in mucosal sites compared with blood and lymphoid organs, consistent with site-specific antigen exposure. Early life mucosal memory T cells exhibit distinct functional capacities and stem-like transcriptional profiles. In later childhood, they progressively adopt proinflammatory functions and tissue-resident signatures, coincident with increased T cell receptor (TCR) clonal expansion in mucosal and lymphoid sites. Together, our findings identify staged development of memory T cells targeted to tissues during the formative years, informing how we might promote and monitor immunity in children.
Program/Contract:
ProgramContract
NIAID Investigator Initiated Program Project Applications (P01) PAR-16-413, PAR-13-254 Tissue compartmentalization of human lymphocytes
DOI: 10.21430/M3VJBRJTM2
Subjects: 45
Study PI, contact:
NameOrganizationSite
Donna Farber Columbia University Columbia University Medical Center
Publications:
Site-specific development and progressive maturation of human tissue-resident memory T cells over infancy and childhood.. Immunity Aug 2023. doi: 10.1016/j.immuni.2023.06.008 [Pubmed: 37421943]
Resources:
GEO series GSE220094]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 129
RNA sequencing 102
T cell receptor repertoire sequencing assay 102
Clinical Assessments:None

SDY2908: Mouse Study 102: Effect of RP-1 Microemulsion on Survival After PBI-BM6mm Irradiation with Thick Lead Restrainer Insert
Status: New
Description: The goal of this study is to test efficacy of RP-1 in microemulsion formulation in a PBI-BM6mm female model with one vs two subcutaneous doses 24h and 72h post-irradiation. For this study, the 9 mm lead restrainer insert was used. Animals will receive Partial Body Irradiation with ~5% bone marrow shielding (PBI-BM6mm) on Tuesday, May 30, 2023. The irradiation dose to be used is 16.0 Gy. Restrained, anesthetized animals will receive partial body irradiation with approximately 5% bone marrow sparing. Shielding will be accomplished by lead bricks placed 6 mm from the irradiator chamber wall and a 9 mm thick lead leg box insert covering bilateral lower femur, tibia, fibula, and paws. Positions R0, R-1, R-2, and R-3 will be used with mice 1-4 placed sequentially in the same positions in each round (i.e. R0 [1], R-1 [2], R-2 [3], R-3 [4]). TLDs will be included in four irradiation runs (1, 4, 7, 9) to validate the four used positions in both shielded and unshielded regions.
Program/Contract:
ProgramContract
NIH Program Intercollaborative Radiation Countermeasure (INTERACT) Consortium for Advanced Development of Medical Countermeasures to Mitigate/Treat Acute and Delayed Radiation Syndromes
DOI: 10.21430/M3KDU43LZA
Subjects: 0
Study PI, contact:
NameOrganizationSite
Gabor Tigyi University of Tennessee Health Science Center University of Tennessee Health Science Center
Sue Chin Lee UTHSC UTHSC
Derek Norman UTHSC UTHSC
Publications:None
Resources:
Assays:None
Clinical Assessments:None

SDY2917: Enhanced placental antibody transfer efficiency with longer interval between maternal respiratory syncytial virus vaccination and birth
Status: New
Description: A prospective cohort study was conducted at 2 academic medical centers between September 20, 2023 and March 21, 2024, enrolling 124 individuals who received the respiratory syncytial virus vaccine during pregnancy. Infant capillary blood was collected at 2 months of age from 29 of the infants. Maternal and cord immunoglobulin G levels achieved by respiratory syncytial virus vaccination were compared to those associated with maternal natural respiratory syncytial virus infection, using banked blood from 20 maternal:cord dyads collected prior to the availability of the maternal respiratory syncytial virus vaccine. Levels of immunoglobulin G against respiratory syncytial virus strain A2 and B fusion (F) and attachment (G) proteins and against pertussis toxin (as a comparator antigen from a vaccine routinely administered earlier in pregnancy) were measured using a Binding Antibody Multiplex Assay. Differences in titers between vaccination and natural infection were examined using Wilcoxon rank-sum test. Differences in cord:maternal transfer ratios and 2-month infant antibody levels by timing of maternal vaccination were evaluated by Kruskal-Wallis testing.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-20-079 Research Project 1 - The pregnancy ImmunOME
DOI: 10.21430/M3E6U41NW0
Subjects: 0
Study PI, contact:
NameOrganizationSite
Andrea G. Edlow Massachusetts General Hospital Massachusetts General Hospital
Michal A. Elovitz Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Ashley Nelson Weill Cornell Medicine Weill Cornell Medicine
Publications:
Enhanced placental antibody transfer efficiency with longer interval between maternal respiratory syncytial virus vaccination and birth.. American journal of obstetrics and gynecology Nov 2024. doi: 10.1016/j.ajog.2024.10.053 [Pubmed: 39515450]
Resources:
Enhanced placental antibody transfer efficiency with longer interval between maternal respiratory syncytial virus vaccination and birth - AJOG https://www.ajog.org/article/S0002-9378(24)01125-6/fulltext]
Assays:None
Clinical Assessments:None

SDY2918: A surrogate ELISA to select high titer human convalescent plasma for treating immunocompromised patients infected with SARS-CoV-2 variants of concern
Status: New
Description: Here, the authors review a surrogate ELISA to select COVID-19 convalescent plasma samples that will guarantee a protective level of neutralizing antibodies as the main correlate of protection.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M36AY0IIO6
Subjects: 0
Study PI, contact:
NameOrganizationSite
Peter Palese Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None

SDY2922: Patient Experiences Navigating Care Coordination For Long COVID: A Qualitative Study
Status: New
Description: Abstract Background Little is known about how to best evaluate, diagnose, and treat long COVID, which presents challenges for patients as they seek care. Objective Understand experiences of patients as they navigate care for long COVID. Design Qualitative study involving interviews with patients about topics related to seeking and receiving care for long COVID. Participants Eligible patients were at least 18 years of age, spoke English, self-identified as functioning well prior to COVID infection, and reported long COVID symptoms continued to impact their lives at 3 months or more after a COVID infection. Approach Patients were recruited from a post-COVID recovery clinic at an academic medical center from August to September 2022. Interviews were audio-recorded, transcribed, and analyzed using thematic analysis. Key Results Participants (n=21) reported experiences related to elements of care coordination: access to care, evaluation, treatment, and ongoing care concerns. Some patients noted access to care was facilitated by having providers that listened to and validated their symptoms; other patients reported feeling their access to care was hindered by providers who did not believe or understand their symptoms. Patients reported confusion around how to communicate their symptoms when being evaluated for long COVID, and they expressed frustration with receiving test results that were normal or diagnoses that were not directly attributed to long COVID. Patients acknowledged that clinicians are still learning how to treat long COVID, and they voiced appreciation for providers who are willing to try new treatment approaches. Patients expressed ongoing care concerns, including feeling there is nothing more that can be done, and questioned long-term impacts on their aging and life expectancy. Conclusions Our findings shed light on challenges faced by patients with long COVID as they seek care. Healthcare systems and providers should consider these challenges when developing strategies to improve care coordination for patients with long COVID. Supplementary Information The online version contains supplementary material available at 10.1007/s11606-024-08622-z.
Program/Contract:
ProgramContract
SeroNet Center for Serological Testing to Improve Outcomes from Pandemic COVID-19 (STOP-COVID)
DOI: 10.21430/M33KSA5PM2
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ann Mcalearney The Ohio State University Medical Center The Ohio State University Medical Center
Alice Gaughan The Ohio State University The Ohio State University
Publications:
Patient Experiences Navigating Care Coordination For Long COVID: A Qualitative Study.. Journal of general internal medicine Jun 2024. doi: 10.1007/s11606-024-08622-z [Pubmed: 38308155]
Resources:
Assays:None
Clinical Assessments:None

SDY2923: COVID-19 vaccination induces distinct T-cell responses in pediatric solid organ transplant recipients and immunocompetent children
Status: New
Description: Immune responses to COVID-19 vaccination are attenuated in adult solid organ transplant recipients (SOTRs) and additional vaccine doses are recommended for this population. However, whether COVID-19 mRNA vaccine responses are limited in pediatric SOTRs (pSOTRs) compared to immunocompetent children is unknown. Due to SARS-CoV-2 evolution and mutations that evade neutralizing antibodies, T cells may provide important defense in SOTRs who mount poor humoral responses. Therefore, we assessed anti-SARS-CoV-2 IgG titers, surrogate neutralization, and spike (S)-specific T-cell responses to COVID-19 mRNA vaccines in pSOTRs and their healthy siblings (pHCs) before and after the bivalent vaccine dose. Despite immunosuppression, pSOTRs demonstrated humoral responses to both ancestral strain and Omicron subvariants following the primary ancestral strain monovalent mRNA COVID-19 series and multiple booster doses. These responses were not significantly different from those observed in pHCs and significantly higher six months after vaccination than responses in adult SOTRs two weeks post-vaccination. However, pSOTRs mounted limited S-specific CD8+ T-cell responses and qualitatively distinct CD4+ T-cell responses, primarily producing IL-2 and TNF with less IFN-γ production compared to pHCs. Bivalent vaccination enhanced humoral responses in some pSOTRs but did not shift the CD4+ T-cell responses toward increased IFN-γ production. Our findings indicate that S-specific CD4+ T cells in pSOTRs have distinct qualities with unknown protective capacity, yet vaccination produces cross-reactive antibodies not significantly different from responses in pHCs. Given altered T-cell responses, additional vaccine doses in pSOTRs to maintain high titer cross-reactive antibodies may be important in ensuring protection against SARS-CoV-2.
Program/Contract:
ProgramContract
SeroNet Johns Hopkins Excellence in Pathogenesis and Immunity Center for SARS-CoV-2 (JH-EPICS)
DOI: 10.21430/M3AXDHDC1C
Subjects: 0
Study PI, contact:
NameOrganizationSite
Andrew Karaba Johns Hopkins University Johns Hopkins University
Andrea Cox Johns Hopkins University Johns Hopkins University
Elizabeth Thompson Johns Hopkins University Johns Hopkins University
Publications:
COVID-19 vaccination induces distinct T-cell responses in pediatric solid organ transplant recipients and immunocompetent children.. NPJ vaccines Apr 2024. doi: 10.1038/s41541-024-00866-4 [Pubmed: 38580714]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
Flow Cytometry 0
Multiplex Immunoassay 0
Clinical Assessments:None

SDY2924: High Frequency of Prior Severe Acute Respiratory Syndrome Coronavirus 2 Infection by Sensitive Nucleocapsid Assays
Status: New
Description: Prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is typically measured by nucleocapsid serology assays. In this study, we show that the Simoa serology assay and T-cell intracellular cytokine staining assay are more sensitive than the clinical Elecsys assay for detection of nucleocapsid-specific immune responses. These data suggest that the prevalence of prior SARS-CoV-2 infection in the population may be higher than currently appreciated.
Program/Contract:
ProgramContract
SeroNet Immunologic Signatures of SARS-CoV-2 Vaccination and Disease
DOI: 10.21430/M30HDWUO6Z
Subjects: 0
Study PI, contact:
NameOrganizationSite
Dan Barouch Beth Israel Deaconess Medical Center - Harvard Medical School Beth Israel Deaconess Medical Center - Harvard Medical School
Ai-ris Collier Beth Israel Deaconess Medical Center - Harvard Medical School Beth Israel Deaconess Medical Center - Harvard Medical School
Publications:
High Frequency of Prior Severe Acute Respiratory Syndrome Coronavirus 2 Infection by Sensitive Nucleocapsid Assays.. The Journal of infectious diseases Sep 2024. doi: 10.1093/infdis/jiae174 [Pubmed: 38566610]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
Flow Cytometry 0
Multiplex Immunoassay 0
Single-Molecule Array (SIMOA) 0
Clinical Assessments:None

SDY2925: Majority of human circulating IgG plasmablasts stop blasting in a cell-free pro-survival culture
Status: New
Description: Following infection or vaccination, early-minted antibody secreting cells (ASC) or plasmablasts appear in circulation transiently, and a small fraction migrates to the spleen or bone marrow (BM) to mature into long-lived plasma cells (LLPC). While LLPC, by definition, are quiescent or non-dividing, the majority of blood ASC are thought to be ""blasting"" or proliferative. In this study, we find > 95% nascent blood ASC in culture express Ki-67 but only 6-12% incorporate BrdU after 4 h or 24 h labeling. In contrast, < 5% BM LLPC in culture are Ki-67+ with no BrdU uptake. Due to limitations of traditional flow cytometry, we utilized a novel optofluidic technology to evaluate cell division with simultaneous functional IgG secretion. We find 11% early-minted blood ASC undergo division, and none of the terminally differentiated BM LLPC (CD19-CD38hiCD138+) divide during the 7-21 days in culture. While BM LLPC undergo complete cell cycle arrest, the process of differentiation into an ASC or plasmablasts also discourages entry into S phase. Since the majority of Ki-67+ nascent blood ASC have exited cell cycle and are no longer actively ""blasting"", the term ""plasmablast"", which traditionally refers to an ASC that still has the capacity to divide, may probably be a misnomer.
Program/Contract:
ProgramContract
SeroNet Immune Regulation of COVID-19 Infection in Cancer and Autoimmunity
DOI: 10.21430/M3K931Z9B7
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ignacio Sanz Emory University Emory University
Frances Eun-hyung Lee Emory University Emory University
Matthew Woodruff Emory University Emory University
Publications:
Majority of human circulating IgG plasmablasts stop blasting in a cell-free pro-survival culture.. Scientific reports Feb 2024. doi: 10.1038/s41598-024-53977-2 [Pubmed: 38350990]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 0
Flow Cytometry 0
Microscopy 0
Clinical Assessments:None

SDY2926: Emergency Myelopoiesis Distinguishes Multisystem Inflammatory Syndrome in Children From Pediatric Severe Coronavirus Disease 2019
Status: New
Description: Background: Multisystem inflammatory syndrome in children (MIS-C) is a hyperinflammatory condition caused by recent infection with severe acute respiratory syndrome coronavirus 2, but the underlying immunological mechanisms driving this distinct syndrome are unknown. Methods: We utilized high-dimensional flow cytometry, cell-free (cf) DNA, and cytokine and chemokine profiling to identify mechanisms of critical illness distinguishing MIS-C from severe acute coronavirus disease 2019 (SAC). Results: Compared to SAC, MIS-C patients demonstrated profound innate immune cell death and features of emergency myelopoiesis (EM), an understudied phenomenon observed in severe inflammation. EM signatures were characterized by fewer mature myeloid cells in the periphery and decreased expression of HLA-DR and CD86 on antigen-presenting cells. Interleukin 27 (IL-27), a cytokine known to drive hematopoietic stem cells toward EM, was increased in MIS-C, and correlated with immature cell signatures in MIS-C. Upon recovery, EM signatures decreased and IL-27 plasma levels returned to normal levels. Despite profound lymphopenia, we report a lack of cfDNA released by adaptive immune cells and increased CCR7 expression on T cells indicative of egress out of peripheral blood. Conclusions: Immune cell signatures of EM combined with elevated innate immune cell-derived cfDNA levels distinguish MIS-C from SAC in children and provide mechanistic insight into dysregulated immunity contributing toward MIS-C, offering potential diagnostic and therapeutic targets.
Program/Contract:
ProgramContract
SeroNet Johns Hopkins Excellence in Pathogenesis and Immunity Center for SARS-CoV-2 (JH-EPICS)
DOI: 10.21430/M3WLKAU6DK
Subjects: 0
Study PI, contact:
NameOrganizationSite
Andrew Karaba Johns Hopkins Medical Institute Johns Hopkins Medical Institute
Andrea Cox Johns Hopkins Medical Institute Johns Hopkins Medical Institute
Elizabeth Thompson Johns Hopkins University Johns Hopkins University
Publications:
Emergency Myelopoiesis Distinguishes Multisystem Inflammatory Syndrome in Children From Pediatric Severe Coronavirus Disease 2019.. The Journal of infectious diseases Aug 2024. doi: 10.1093/infdis/jiae032 [Pubmed: 38299308]
Resources:
cRNAseq dataset: GSE166489 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE166489]
Pre-pandemic plasma samples from healthy controls were obtained under protocol: NCT02179151 https://clinicaltrials.gov/study/NCT02179151]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 0
Multiplex Immunoassay 0
PCR 0
RNA sequencing 0
Clinical Assessments:None

SDY2927: SARS-CoV-2 Variants from Long-Term, Persistently Infected Immunocompromised Patients Have Altered Syncytia Formation, Temperature-Dependent Replication, and Serum Neutralizing Antibody Escape
Status: New
Description: SARS-CoV-2 infection of immunocompromised individuals often leads to prolonged detection of viral RNA and infectious virus in nasal specimens, presumably due to the lack of induction of an appropriate adaptive immune response. Mutations identified in virus sequences obtained from persistently infected patients bear signatures of immune evasion and have some overlap with sequences present in variants of concern. We characterized virus isolates obtained greater than 100 days after the initial COVID-19 diagnosis from two COVID-19 patients undergoing immunosuppressive cancer therapy, wand compared them to an isolate from the start of the infection. Isolates from an individual who never mounted an antibody response specific to SARS-CoV-2 despite the administration of convalescent plasma showed slight reductions in plaque size and some showed temperature-dependent replication attenuation on human nasal epithelial cell culture compared to the virus that initiated infection. An isolate from another patient-who did mount a SARS-CoV-2 IgM response-showed temperature-dependent changes in plaque size as well as increased syncytia formation and escape from serum-neutralizing antibodies. Our results indicate that not all virus isolates from immunocompromised COVID-19 patients display clear signs of phenotypic change, but increased attention should be paid to monitoring virus evolution in this patient population.
Program/Contract:
ProgramContract
SeroNet Johns Hopkins Excellence in Pathogenesis and Immunity Center for SARS-CoV-2 (JH-EPICS)
DOI: 10.21430/M3YU1G5K1K
Subjects: 0
Study PI, contact:
NameOrganizationSite
Andrew Pekosz Johns Hopkins University Johns Hopkins University
Publications:
SARS-CoV-2 Variants from Long-Term, Persistently Infected Immunocompromised Patients Have Altered Syncytia Formation, Temperature-Dependent Replication, and Serum Neutralizing Antibody Escape.. Viruses Sep 2024. doi: 10.3390/v16091436 [Pubmed: 39339912]
Resources:
Raw data and images: Johns Hopkins University Data Repository https://archive.data.jhu.edu/dataset.xhtml?persistentId=doi:10.7281/T1/RDLYMJ]
Github https://github.com/Pekosz-Lab/Wouters_2024_CHLA]
SARS-CoV-2 Wuhan-Hu-1 complete genome https://www.ncbi.nlm.nih.gov/nuccore/NC_045512.2/]
Patient characteristics from PMID33915337 https://pubmed.ncbi.nlm.nih.gov/33915337/]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 0
Microscopy 0
Neutralizing Antibody Titer Assay 0
Plaque Reduction Neutralization Assay 0
RNA sequencing 0
Virus Plaque Assay 0
Clinical Assessments:None

SDY2928: Three SARS-CoV-2 spike protein variants delivered intranasally by measles and mumps vaccines are broadly protective
Status: New
Description: As the new SARS-CoV-2 Omicron variants and subvariants emerge, there is an urgency to develop intranasal, broadly protective vaccines. Here, we developed highly efficacious, intranasal trivalent SARS-CoV-2 vaccine candidates (TVC) based on three components of the MMR vaccine: measles virus (MeV), mumps virus (MuV) Jeryl Lynn (JL1) strain, and MuV JL2 strain. Specifically, MeV, MuV-JL1, and MuV-JL2 vaccine strains, each expressing prefusion spike (preS-6P) from a different variant of concern (VoC), were combined to generate TVCs. Intranasal immunization of IFNAR1−/− mice and female hamsters with TVCs generated high levels of S-specific serum IgG antibodies, broad neutralizing antibodies, and mucosal IgA antibodies as well as tissue-resident memory T cells in the lungs. The immunized female hamsters were protected from challenge with SARS-CoV-2 original WA1, B.1.617.2, and B.1.1.529 strains. The preexisting MeV and MuV immunity does not significantly interfere with the efficacy of TVC. Thus, the trivalent platform is a promising next-generation SARS-CoV-2 vaccine candidate.
Program/Contract:
ProgramContract
SeroNet Center for Serological Testing to Improve Outcomes from Pandemic COVID-19 (STOP-COVID)
DOI: 10.21430/M3XNP4WCS0
Subjects: 0
Study PI, contact:
NameOrganizationSite
Shan-lu Liu The Ohio State University The Ohio State University
Prosper Boyaka The Ohio State University The Ohio State University
Jacob Yount The Ohio State University Medical Center The Ohio State University Medical Center
Publications:
Three SARS-CoV-2 spike protein variants delivered intranasally by measles and mumps vaccines are broadly protective.. Nature communications Jul 2024. doi: 10.1038/s41467-024-49443-2 [Pubmed: 38961063]
Resources:
SARS-CoV-2 USA-WA1/2020 (WA1) natural isolate https://www.ncbi.nlm.nih.gov/nuccore/MN985325]
Mouse-adapted (MA) SARS-CoV-2 USA-WA1/2020 (strain MA10) https://www.ncbi.nlm.nih.gov/nuccore/MT952602]
SARS-CoV-2 Delta (B.1.617.2) https://gisaid.org/ EPI_ISL_2331496]
SARS-CoV-2 Omicron BA.1 (B.1.1.529) https://gisaid.org/ EPI_ISL_7160424]
A set of 181 peptides spanning the complete spike protein of the USA-WA1/2020 strain of SARS-CoV-2 (GenPept: QHO60594) https://www.ncbi.nlm.nih.gov/protein/QHO60594]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Flow Cytometry 0
Microscopy 0
Pseudovirus Neutralization Assay 0
Virus Plaque Assay 0
Western Blot 0
Clinical Assessments:None

SDY2931: SeroNet Longitudinal Study v4.2.1
Status: New
Description: The longitudinal serosurveillance study aimed to understand the immune responses to COVID-19 vaccination and SARS-CoV-2 infection. Between 2021 and 2024, four Capacity Building Centers (CBC) collected samples from 3284 participants (3119 are being released), including healthy and immunocompromised populations. Demographic and clinical data were collected for all participants, with 61% female, ages ranged from 0 to > 89 years, and 68% white. Among the 1,806 participants in the general population, 901 were in the Healthy cohort (no reported comorbidities), and 905 were in the Comorbidity cohort (with 1 or more reported comorbidities or chronic conditions). CBCs collected more detailed information from participants in select cohorts (e.g. time of diagnosis, treatment): 824 in Cancer, 162 in IBD, 146 in HIV and 181 transplant recipients. There were on average 4.7 visits per participant. Collection timepoints were strategically aligned for before and after vaccine administration or infection: 30, 60, 90, 120, 180 and 360 days. Vaccination status for participants range from unvaccinated to vaccinated with homologous and heterologous primary series and booster doses. Vaccines used were the licensed mRNA-based vaccines in the large majority of Janssen protein subunit vaccine in X% of cases. Data harmonization was achieved through SeroNet templates submitted by each CBC, validated for business rule compliance, then shipped to the NCI FNL Central Repository
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research (FNLCR) Center for SARS-CoV-2 Serological Sciences
DOI: 10.21430/M3AXZXJN91
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ligia Pinto Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Nancy Roche Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Thomas Hickey Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Patrick Breads Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Elaine Freund Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Anjan Purkayastha Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Peter Gregersen Feinstein Institute For Medical Research Feinstein Institute For Medical Research
Amy Karger University of Minnesota University of Minnesota
Joshua Labaer Arizona State University Arizona State University
Carlos Cordon-cardo Icahn School of Medicine at Mount Sinai Icahn Scool of Medicine at Mt. Sinai
Vel Murugan Arizona State University Arizona State University
Michael Ritchie Arizona State University Arizona State University
Komal Srivastav Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Charles Gleason Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Elena Kowalsky Feinstein Institute For Medical Research Feinstein Institute For Medical Research
Michael Ryan Feinstein Institute For Medical Research Feinstein Institute For Medical Research
Alex Mathson University of Minnesota University of Minnesota
Bharat Thyagarajan University of Minnesota University of Minnesota
Shreya Sanghani Feinstein Institute For Medical Research Feinstein Institute For Medical Research
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
ELISA 0
Clinical Assessments:None

SDY2932: Co-administration of seasonal quadrivalent influenza and COVID-19 vaccines leads to enhanced immune responses to influenza virus and reduced immune responses to SARS-CoV-2 in naive mice
Status: New
Description: The authors assessed the protective efficacy and humoral immune responses elicited by concomitant administration of a QIV and the Pfizer-BioNTech mRNA COVID-19 vaccine in naive BALB/c mice.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3DYPQ4GBE
Subjects: 0
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Anass Abbad Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None

SDY2933: Induction of stalk-reactive antibodies with ADCC reporter activity by administration of a live-attenuated influenza virus vaccine to children
Status: New
Description: Here, the authors sought to determine if certain responses could be induced through administration of LAIV to influenza vaccine naive young children, with different influenza virus exposure histories.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3K0EKEXK5
Subjects: 0
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None

SDY2934: CpG ACE-Dextran MP
Status: New
Description: CpG MP expressing COBRA elicits broadly reactive antibodies
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3BYLWXJNY
Subjects: 0
Study PI, contact:
NameOrganizationSite
Kristy Ainslie University of North Carolina University of North Carolina, Center for Influenza Vaccine Research for High-Risk Populations
Publications:
Sustained delivery of CpG oligodeoxynucleotide by acetalated dextran microparticles augments effector response to Computationally Optimized Broadly Reactive Antigen (COBRA) influenza hemagglutinin.. International journal of pharmaceutics Jan 2023. doi: 10.1016/j.ijpharm.2022.122429 [Pubmed: 36436743]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None

SDY2943: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation
Status: New
Description: This is an open-label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3-7 months post-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy. The original study design included an additional treatment arm with a single dose of darTregs. However, due to the inability to manufacture an adequate number of cells for infusion, this treatment arm was removed from the study in protocol version 9.0. One subject was treated in the darTreg arm and completed follow-up prior to the arm being removed from the protocol. The accrual goal for the study was reduced due to the removal of this arm as well as challenges associated with recruitment of participants in the setting of the COVID-19 pandemic. Given that this is primarily a pilot, proof-of-concept, we believe that the target of 7 evaluable participants in each arm is sufficient to provide the necessary clinical and mechanistic data that will allow us to assess the impact of polyTregs on graft inflammation.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) Applying precision MEdicine to optimize desensitization with noveL bIOlogics or cellular theRApies in highly sensiTized kidney transplant patiEnts (AMELIORATE)
DOI: 10.21430/M36RLSSI99
Subjects: 16
Study PI, contact:
NameOrganizationSite
Flavio Vincenti UCSF UCSF
Publications:None
Resources:
Assays:None
Clinical Assessments:None

SDY2944: Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6
Status: New
Description: A significant problem that continues to challenge transplant physicians is the need to develop immunosuppression strategies that can usher in a tolerant state without the risks associated with conditioning regimens or the threat of graft versus host disease (GVHD) associated with infused stem cells. Other challenges include maintenance of the stability of the tolerant state and the availability of reproducible biomarkers for tolerance. Combining CD28 inhibition with blockade of other co-stimulation tracts or other co-activation pathways has been shown to induce long-term graft acceptance in experimental transplants (Kirk, 1997) (Larsen, 2005) (Zhao, 2012). Co-stimulation inhibition with CTLA4Ig or its second-generation sister drug, belatacept, inhibits T cell activation in vitro and induces anergy but neither agent by itself has been shown to induce tolerance in experimental or clinical organ transplantation (Larsen, 2005) (Kirk, 2014). While tolerance has been demonstrated only in small animals, based on the mechanism of action of IL6 and CTLA4-Ig, their combined inhibition may result in a Treg-mediated tolerogenic environment. CTOT-24 will use a novel therapeutic approach to combine anti-CD28 therapy using lulizumab pegol (BMS-931699) initially, followed by Belatacept, along with inhibition of the IL6 pathway by tocilizumab, an anti-IL6R monoclonal antibody.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) Applying precision MEdicine to optimize desensitization with noveL bIOlogics or cellular theRApies in highly sensiTized kidney transplant patiEnts (AMELIORATE)
DOI: 10.21430/M3LLNPRDY9
Subjects: 15
Study PI, contact:
NameOrganizationSite
Flavio Vincenti UCSF UCSF
Publications:None
Resources:
Assays:None
Clinical Assessments:None

SDY2947: Systems immunology analysis of human tonsil organoids identifies host-specific correlates of protection to different influenza vaccines
Status: New
Description: This study explores the underlying mechanisms of immune responses to influenza vaccines using a systems immunology approach. Despite the success of vaccines in reducing global morbidity and mortality, challenges remain in developing effective vaccines against complex pathogens like influenza. This research aims to bridge the knowledge gap by systematically analyzing cellular and molecular responses to various flu vaccines. The study involved 100 donors where we assessed their immune responses to seven different flu vaccine/antigen formats, including live attenuated, inactivated, and recombinant protein vaccines. We observed significant baseline variability in tissue immune cell composition, with age-related and age-independent heterogeneity affecting vaccine outcomes. Donor cellular and humoral immune responses were characterized using extensive flow cytometry and antibody magnitude, breadth, and function were assessed using ELISAs, microarray analysis, and microneutralization assays, respectively. Antigen format was found to significantly influence immune responses, with live vaccines inducing stronger responses compared to non-live vaccines. Interestingly, we found that strong responders to inactivated vaccines demonstrated immune responses which resembled those observed following live vaccine stimulation. To predict and explain disparities in vaccine responses, a machine learning model was developed to identify cellular features correlated with antibody responses. A key finding was the role of Th1 cells in predicting and enhancing antibody responses to inactivated influenza vaccines (IIVs). Further validation through gene expression analysis and cytokine assays supported the potential of Th1 cells as biomarkers of vaccine efficacy. This study provides valuable insights into the factors influencing vaccine responses and identifies Th1 cells as a potential target for improving vaccine design and effectiveness. The purpose of this project was to demonstrate the translational value of using human tissues for predicting vaccine responses. While Th1s were selected as our validation population, this study includes several other populations, not validated in this project, which may play additional or complementary roles in enhancing vaccine responses.
Program/Contract:
ProgramContract
NIH Program Investigating protective adaptive immune responses to influenza antigens using human tonsil organoids
DOI: 10.21430/M3BJETI5YU
Subjects: 800
Study PI, contact:
NameOrganizationSite
Zachary Wagoner UC Irvine UC Irvine
Timothy Yates UC Irvine UC Irvine
Jenny Hernandez-Davies UC Irvine UC Irvine
Suhas Sureshchandra UC Irvine UC Irvine
Aarti Jain UC Irvine UC Irvine
Rafael de Assis UC Irvine UC Irvine
Jenna Kastenschmidt UC Irvine UC Irvine
Andrew Sorn UC Irvine UC Irvine
Mahina Mitul UC Irvine UC Irvine
Erika Joloya UC Irvine UC Irvine
Ian Tamburini UC Irvine UC Irvine
Gurpreet Ahuja CHOC CHOC
Qiu Zhong CHOC CHOC
Douglas Trask UC Irvine UC Irvine
Marcus Seldin UC Irvine UC Irvine
David (Huw) Davies UC Irvine UC Irvine
Lisa Wagar UC Irvine UC Irvine
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 8523
Virus Neutralization 800
Clinical Assessments:None

Updated Studies

SDY2656: SeroNet Reference Study v2.2
Status: New
Description: The Reference Study supported development of the National SARS-CoV-2 Serology Standard and assay validation panels. Four Capacity Building Centers (CBCs) collected large volume samples from unvaccinated individuals infected with SARS-CoV-2 and from unvaccinated, uninfected individuals during a visit from 2020-2021 (prior to vaccine availability). Aliquoted serum and PBMCs at 106 M cells per vial, typically at 1ml, from this study may be requested. Demographic and clinical data were collected for 909 participants, 53% of whom were female, and ages ranged from 15 to 80. Detailed information on race and ethnicity was also recorded. The collection is characterized, and includes tertiles of positive test serology results for demographics and other infectious diseases. Sample Testing Samples from these participants were tested with SARS and Non-SARS Molecular and Serology assays. All samples were tested for SARS-CoV-2 positivity by the CBCs using immunoassays and in the FNL Serology Laboratory using an ELISA assay. Additional confirmatory testing was performed by 2 other laboratories. Samples were tested for IgG and IgM antibodies against the SARS-CoV-2 Spike and Nucleocapsid proteins. Positivity for Spike IgG was 67%, spike IgM was 11%, nucleocapsid IgG was 33% and IgM was 16%. Alongside this, many samples were tested for coinfections. Of those tested, 95% were positive for EBV, 47% were positive for CMV. Few samples were tested for HIV and HepB, with a low positivity rate. All samples were tested for seasonal coronavirus and 35% were positive.
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research (FNLCR) Center for SARS-CoV-2 Serological Sciences
DOI: 10.21430/M3AUTZYP4Q
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ligia Pinto Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Nancy Roche Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Troy Kemp Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Thomas Hickey Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Patrick Breads Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Elaine Freund Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Deborah Hope Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Anjan Purkayastha Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Peter Gregersen Feinstein Institute For Medical Research Feinstein Institute For Medical Research
Amy Karger University of Minnesota University of Minnesota
Joshua Labaer Arizona State University Arizona State University
Carlos Cordon-cardo Icahn Scool of Medicine at Mt. Sinai Icahn Scool of Medicine at Mt. Sinai
Prem Lakshmanane University of North Carolina at Chapel Hill University of North Carolina at Chapel Hill
Ralph Baric University of North Carolina at Chapel Hill University of North Carolina at Chapel Hill
Vel Murugan Arizona State University Arizona State University
Michael Ritchie Arizona State University Arizona State University
Komal Srivastav Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Charles Gleason Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Elena Kowalsky Feinstein Institute for Medical Research Feinstein Institute for Medical Research
Michael Ryan Feinstein Institute for Medical Research Feinstein Institute for Medical Research
Alex Mathson University of Minnesota University of Minnesota
Bharat Thyagarajan University of Minnesota University of Minnesota
Shreya Sanghani � Feinstein Institute for Medical Research Feinstein Institute for Medical Research
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
ELISA 0
Lateral Flow Assay 0
Multiplex Immunoassay 0
Clinical Assessments:None

SDY395: Immune Responses to Influenza-Like Illness SLVP022 2012
Status: Updated
Description: To investigate the nasal transcriptional response and peripheral plasmablast response in acute influenza infection
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33RY4IXN7
Subjects: 33
Study PI, contact:
NameOrganizationSite
Harry Greenberg Stanford School of Medicine Stanford School of Medicine
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Luminex xMAP 28
Clinical Assessments:None

SDY406: Immune Responses to Influenza-Like Illness SLVP022 2013 through 2018
Status: Updated
Description: To investigate the nasal transcriptional response and peripheral plasmablast response in acute influenza infection
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3U4SDFNWN
Subjects: 86
Study PI, contact:
NameOrganizationSite
Harry Greenberg Stanford School of Medicine Stanford School of Medicine
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 567
ELISA 6
Hemagglutination Inhibition 6
Luminex xMAP 154
Transcription profiling by array 4
Clinical Assessments:None

SDY1446: Comparing aerosol and intradermal boost regimes of candidate TB vaccine MVA85A.
Status: Updated
Description: There is an urgent need for an effective tuberculosis (TB) vaccine. Heterologous prime-boost regimens with recombinant viral vectors are effective at inducing induce high levels of potent cellular immunity. MVA85A is a candidate TB vaccine designed to boost BCG-induced immunity. This phase I experimental medicine clinical trial was designed to evaluate whether alternating aerosol and intradermal vaccination routes would boost the immune response cellular immunity to the Mycobacterium tuberculosis antigen 85A.
Program/Contract:
ProgramContract
NIHR Biomedical Research Centres (BRCs) NIHR Biomedical Research Centre at Oxford University Hospitals NHS Foundation Trust and the University of Oxford
DOI: 10.21430/M3ER3DU6NW
Subjects: 37
Study PI, contact:
NameOrganizationSite
Helen McShane University of Oxford Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Publications:
Alternate aerosol and systemic immunisation with a recombinant viral vector for tuberculosis, MVA85A: A phase I randomised controlled trial.. PLoS medicine Apr 2019. doi: 10.1371/journal.pmed.1002790 [Pubmed: 31039172]
Resources:
ClinicalTrials.gov Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A https://clinicaltrials.gov/ct2/show/NCT01954563]
EU Clinical Trials Register (N.B. EudraCT does not display phase 1 trials) 2013-002020-16]
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 792
Clinical Assessments:
Bronchoscopy

SDY1828: Romiplostim (Nplate) Efficacy Study with or without Pegfilgrastim (Neulasta) in a Rhesus Macaque H-ARS Model
Status: Updated
Description: Nplate was given subcutaneously (5 mg/kg on Day 1) to Co-60 irradiated (target LD70/60) rhesus macaques. Neulasta was given subcutaneously (0.3 mg/kg on Days 1 and 8) to rhesus macaques. Each group consisted of 20 male and 20 female animals. Survival was compared to a control group that received injections of the appropriate vehicles. Note: Day 1 is 24 hours after the day of irradiation, which is designated in the data files as Day -1. There is no Day 0. Keywords: rhesus macaques, macaca mulatta, radiation, radiation sickness, hematopoietic, hematology, romiplostim, platelet, thrombocytopenia, pharmacodynamics, drug therapy
Program/Contract:
ProgramContract
Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services Contract Opportunity for Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services
DOI: 10.21430/M35SO7682U
Subjects: 0
Study PI, contact:
NameOrganizationSite
Polly Chang SRI International SRI International
Publications:
Survival and Hematologic Benefits of Romiplostim After Acute Radiation Exposure Supported FDA Approval Under the Animal Rule.. International journal of radiation oncology, biology, physics May 2023. doi: 10.1016/j.ijrobp.2023.05.008 [Pubmed: 37224926]
Resources:
Assays:None
Clinical Assessments:None

SDY2113: Augmentation of humoral and cellular immune responses after third-dose SARS-CoV-2 vaccination and viral neutralization in myeloma patients
Status: Updated
Description: Despite the efficacy of COVID-19 vaccines in healthy individuals, multiple myeloma (MM) patients are immunocompromised and mount suboptimal humoral and cellular responses after two doses of mRNA vaccine (Addeo et al., 2021; Aleman et al., 2021; Van Oekelen et al., 2021). A broader observation of limited vaccine responses in cancer patients, particularly those with hematologic malignancies (Thakkar et al., 2021), has led to the implementation of additional (i.e., third dose) vaccine administration as a way to increase protection for patients with immune suppression. A third dose of BNT162b2 (Pfizer-BioNTech) COVID19 vaccine has shown to be effective in preventing severe COVID-19 caused by the SARS-CoV-2 B.1.617.2 (Delta) variant in the general population (Bar-On et al., 2021; Barda et al., 2021). Furthermore, third-dose administration of either the BNT162b2 (Pfizer-BioNTech) or mRNA1273 (Moderna) COVID-19 vaccine was associated with augmented immune responses in a diverse cohort of cancer patients (Shapiro et al., 2022). However, the real-world effectiveness of additional dosing in myeloma patients and viral neutralization have not been reported. Additionally, the impact of the currently dominant SARS-CoV-2 B.1.1.529 (Omicron) variant on efficacy of the third dose is largely unknown in patients with hematologic malignancies (Zeng et al., 2022).
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3EEDBBP9C
Subjects: 0
Study PI, contact:
NameOrganizationSite
Cordon-cardo Carlos Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Ania Wajnberg Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Augmentation of humoral and cellular immune responses after third-dose SARS-CoV-2 vaccination and viral neutralization in myeloma patients.. Cancer cell May 2022. doi: 10.1016/j.ccell.2022.03.013 [Pubmed: 35390296]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Flow Cytometry 0
Neutralizing Antibody Titer Assay 0
Clinical Assessments:None

SDY2114: Longitudinal analysis of severe acute respiratory syndrome coronavirus 2 seroprevalence using multiple serology platforms
Status: Updated
Description: Current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests are based on the full-length spike (S), the receptor-binding domain (RBD), or the nucleoprotein (NP) as substrates. Here, we used samples from healthcare workers (HCWs) to perform a longitudinal analysis of the antibody responses using a research-grade RBD and spike-based enzyme-linked immunosorbent assay (ELISA), a commercial RBD and spike-based ELISA, and a commercial NP-based chemiluminescent microparticle immunoassay. Seroprevalence ranged around 28% early during the pandemic and a good correlation was observed between RBD and spike-based ELISAs. Modest correlations were observed between NP and both RBD and spike-based assays. The antibody levels in HCWs declined over time; however, the overall seroprevalence measured by RBD and spike-based assays remained unchanged, while the seroprevalence of NP-reactive antibodies significantly declined. Moreover, RBD and spike-based assays effectively detected seroconversion in vaccinees. Overall, our results consolidate the strength of different serological assays to assess the magnitude and duration of antibodies to SARS-CoV-2.
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3S0T656KV
Subjects: 0
Study PI, contact:
NameOrganizationSite
Damodara Rao Mendu The Icahn School of Medicine at Mount Sinai The Icahn School of Medicine at Mount Sinai
Viviana Simon The Icahn School of Medicine at Mount Sinai The Icahn School of Medicine at Mount Sinai
Florian Krammer The Icahn School of Medicine at Mount Sinai The Icahn School of Medicine at Mount Sinai
Publications:
Longitudinal analysis of severe acute respiratory syndrome coronavirus 2 seroprevalence using multiple serology platforms.. iScience Sep 2021. doi: 10.1016/j.isci.2021.102937 [Pubmed: 34368647]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
ELISA 0
Clinical Assessments:None

SDY2115: Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial
Status: Updated
Description: Background: Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It's being developed by public sector manufacturers in Thailand, Vietnam, and Brazil; herein are initial results from Thailand. Methods: This phase 1 stage of a randomised, dose-escalation, observer-blind, placebo-controlled, phase 1/2 trial was conducted at the Vaccine Trial Centre, Mahidol University (Bangkok). Healthy males and non-pregnant females, aged 18-59 years and negative for SARS-CoV-2 antibodies, were eligible. Participants were randomised to receive one of six treatments by intramuscular injection twice, 28 days apart: 1 µg, 1 µg+CpG1018 (a toll-like receptor 9 agonist), 3 µg, 3 µg+CpG1018, 10 µg, or placebo. Participants and personnel assessing outcomes were masked to treatment. The primary outcomes were solicited and spontaneously reported adverse events (AEs) during 7 and 28 days after each vaccination, respectively. Secondary outcomes were immunogenicity measures (anti-S IgG and pseudotyped virus neutralisation). An interim analysis assessed safety at day 57 in treatment-exposed individuals and immunogenicity through day 43 per protocol. ClinicalTrials.gov (NCT04764422). Findings: Between March 20 and April 23, 2021, 377 individuals were screened and 210 were enroled (35 per group); all received dose one; five missed dose two. The most common solicited AEs among vaccinees, all predominantly mild, were injection site pain (<63%), fatigue (<35%), headache (<32%), and myalgia (<32%). The proportion reporting a vaccine-related AE ranged from 5·7% to 17·1% among vaccine groups and was 2·9% in controls; there was no vaccine-related serious adverse event. The 10 µg formulation's immunogenicity ranked best, followed by 3 µg+CpG1018, 3 µg, 1 µg+CpG1018, and 1 µg formulations. On day 43, the geometric mean concentrations of 50% neutralising antibody ranged from 122·23 international units per mL (IU/mL; 1 µg, 95% confidence interval (CI) 86·40-172·91) to 474·35 IU/mL (10 µg, 95% CI 320·90-701·19), with 93·9% to 100% of vaccine groups attaining a ≥ 4-fold increase over baseline. Interpretation: NDV-HXP-S had an acceptable safety profile and potent immunogenicity. The 3 µg and 3 µg+CpG1018 formulations advanced to phase 2
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M301KI6WVE
Subjects: 0
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial.. EClinicalMedicine Mar 2022. doi: 10.1016/j.eclinm.2022.101323 [Pubmed: 35284808]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
ELISPOT 0
Pseudovirus Neutralization Assay 0
Clinical Assessments:None

SDY2134: The risk of COVID-19 death is much greater and age dependent with type I IFN autoantibodies
Status: Updated
Description: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection fatality rate doubles with every 5 y of age from childhood onward. Circulating autoantibodies neutralizing IFN-α, IFN-ω, and/or IFN-β are found in ∼20% of deceased patients across age groups, and in ∼1% of individuals aged <70 y and in >4% of those >70 y old in the general population. With a sample of 1,261 unvaccinated deceased patients and 34,159 individuals of the general population sampled before the pandemic, we estimated both IFR and relative risk of death (RRD) across age groups for individuals carrying autoantibodies neutralizing type I IFNs, relative to noncarriers. The RRD associated with any combination of autoantibodies was higher in subjects under 70 y old. For autoantibodies neutralizing IFN-α2 or IFN-ω, the RRDs were 17.0 (95% CI: 11.7 to 24.7) and 5.8 (4.5 to 7.4) for individuals <70 y and ≥70 y old, respectively, whereas, for autoantibodies neutralizing both molecules, the RRDs were 188.3 (44.8 to 774.4) and 7.2 (5.0 to 10.3), respectively. In contrast, IFRs increased with age, ranging from 0.17% (0.12 to 0.31) for individuals <40 y old to 26.7% (20.3 to 35.2) for those ≥80 y old for autoantibodies neutralizing IFN-α2 or IFN-ω, and from 0.84% (0.31 to 8.28) to 40.5% (27.82 to 61.20) for autoantibodies neutralizing both. Autoantibodies against type I IFNs increase IFRs, and are associated with high RRDs, especially when neutralizing both IFN-α2 and IFN-ω. Remarkably, IFRs increase with age, whereas RRDs decrease with age. Autoimmunity to type I IFNs is a strong and common predictor of COVID-19 death.
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center –Feinstein Institutes for Medical Research
DOI: 10.21430/M32LEYGFC5
Subjects: 0
Study PI, contact:
NameOrganizationSite
Peter Gregersen Feinstein Institutes For Medical Research Feinstein Institutes For Medical Research
Publications:
The risk of COVID-19 death is much greater and age dependent with type I IFN autoantibodies.. Proceedings of the National Academy of Sciences of the United States of America May 2022. doi: 10.1073/pnas.2200413119 [Pubmed: 35576468]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2141: Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 in the United States: Living Density, Viral Load, and Disproportionate Impact on Communities of Color
Status: Updated
Description: Background: Households are hot spots for severe acute respiratory syndrome coronavirus 2 transmission. Methods: This prospective study enrolled 100 coronavirus disease 2019 (COVID-19) cases and 208 of their household members in North Carolina though October 2020, including 44% who identified as Hispanic or non-White. Households were enrolled a median of 6 days from symptom onset in the index case. Incident secondary cases within the household were detected using quantitative polymerase chain reaction of weekly nasal swabs (days 7, 14, 21) or by seroconversion at day 28. Results: Excluding 73 household contacts who were PCR-positive at baseline, the secondary attack rate (SAR) among household contacts was 32% (33 of 103; 95% confidence interval [CI], 22%-44%). The majority of cases occurred by day 7, with later cases confirmed as household-acquired by viral sequencing. Infected persons in the same household had similar nasopharyngeal viral loads (intraclass correlation coefficient = 0.45; 95% CI, .23-.62). Households with secondary transmission had index cases with a median viral load that was 1.4 log10 higher than those without transmission (P = .03), as well as higher living density (more than 3 persons occupying fewer than 6 rooms; odds ratio, 3.3; 95% CI, 1.02-10.9). Minority households were more likely to experience high living density and had a higher risk of incident infection than did White households (SAR, 51% vs 19%; P = .01). Conclusions: Household crowding in the context of high-inoculum infections may amplify the spread of COVID-19, potentially contributing to disproportionate impact on communities of color.
Program/Contract:
ProgramContract
SeroNet North Carolina Seronet Center for Excellence
DOI: 10.21430/M31ZDULPAH
Subjects: 92
Study PI, contact:
NameOrganizationSite
Prem Lakshmanane University of North Carolina School of Medicine University of North Carolina School of Medicine
Lin Jessica University of North Carolina School of Medicine University of North Carolina School of Medicine
Publications:
Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 in the United States: Living Density, Viral Load, and Disproportionate Impact on Communities of Color.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America May 2022. doi: 10.1093/cid/ciab701 [Pubmed: 34383889]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Lateral Flow Assay 0
PCR 0
Clinical Assessments:
Comorbidity or Underlying Condition
Household Information
Symptom Evaluation
Vital Signs

SDY2172: Variable cellular responses to SARS-CoV-2 in fully vaccinated patients with multiple myeloma
Status: Updated
Description: We wanted to determine whether MM patients without detectable anti-S IgG antibodies to SARS-CoV-2 immunization (seronegative) had detectable SARSCoV-2 B and T cell responses after SARS-CoV-2 vaccination, which would possibly provide some protection against severe disease even in the absence of anti-S antibodies. In order to assay quantitative and qualitative differences in T cell responses, we adopted a high-resolution flow cytometry assay that incorporates multiple cytokines and activation markers. Such data are urgently required to guide masking, social distancing, and passive antibody/booster vaccination strategies for potentially vulnerable MM patients treated with these anti-cancer agents as we enter the second fall season of the COVID-19 pandemic.
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3JLICY0TG
Subjects: 0
Study PI, contact:
NameOrganizationSite
Carlos Cordon-cardo Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Ania Wajnberg Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Variable cellular responses to SARS-CoV-2 in fully vaccinated patients with multiple myeloma.. Cancer cell Nov 2021. doi: 10.1016/j.ccell.2021.09.015 [Pubmed: 34706273]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
ELISPOT 0
Flow Cytometry 0
Clinical Assessments:None

SDY2187: Microbiome Preterm Birth DREAM Challenge
Status: Updated
Description: Globally, every year about 11% of infants are born preterm, defined as a birth prior to 37 weeks of gestation, with significant and lingering health consequences. Multiple studies have related the vaginal microbiome to preterm birth. We present a crowdsourcing approach to predict: (a) preterm or (b) early preterm birth from 9 publicly available vaginal microbiome studies representing 3,578 samples from 1,268 pregnant individuals, aggregated from raw sequences via an open-source tool, MaLiAmPi. We validated the crowdsourced models on novel datasets representing 331 samples from 148 pregnant individuals. From 318 DREAM challenge participants we received 148 and 121 submissions for our two separate prediction sub-challenges with top-ranking submissions achieving bootstrapped AUROC scores of 0.69 and 0.87, respectively. Alpha diversity, VALENCIA community state types, and composition (via phylotype relative abundance) were important features in the top performing models, most of which were tree based methods. This work serves as the foundation for subsequent efforts to translate predictive tests into clinical practice, and to better understand and prevent preterm birth.
Program/Contract:
ProgramContract
March of Dimes March of Dimes
DOI: 10.21430/M3JMMPMLSP
Subjects: 750
Study PI, contact:
NameOrganizationSite
Marina Sirota UCSF UCSF
Jonathan Golob University of Michigan March of Dimes Prematurity Research Center
Tomiko Oskotsky University of California San Francisco March of Dimes Prematurity Research Center
Alennie Roldan University of California San Francisco March of Dimes Prematurity Research Center
Alice Tang University of California San Francisco March of Dimes Prematurity Research Center
Connie Ha University of California San Francisco Benioff Center for Microbiome Medicine
Ronald Wong Stanford University March of Dimes Prematurity Research Center
Samuel Minot Fred Hutchinson Cancer Center Data Core
Gaia Andreoletti University of California San Francisco March of Dimes Prematurity Research Center
Idit Kosti University of California San Francisco March of Dimes Prematurity Research Center
Kevin Theis Wayne State University Department of Biochemistry, Microbiology, and Immunology
Sherrianne Ng Imperial College London March of Dimes Prematurity Research Center
Yun Lee Imperial College London March of Dimes Prematurity Research Center
Phillip Bennett Imperial College London March of Dimes Prematurity Research Center
David MacIntyre Imperial College London March of Dimes Prematurity Research Center
Susan Lynch University of California San Francisco Benioff Center for Microbiome Medicine
Roberto Romero National Institutes of Health Perinatology Research Branch
Adi Tarca Wayne State University Perinatology Research Branch
David Stevenson Stanford University Center for Academic Medicine
Nima Aghaeepour Stanford University March of Dimes Prematurity Research Center
Marina Sirota University of California San Francisco March of Dimes Prematurity Research Center
Publications:
None. None None None. doi: None [Pubmed: 36993193]
Microbiome preterm birth DREAM challenge: Crowdsourcing machine learning approaches to advance preterm birth research.. Cell reports. Medicine Jan 2024. doi: 10.1016/j.xcrm.2023.101350 [Pubmed: 38134931]
Resources:
Assays:None
Clinical Assessments:None

SDY2243: Ultrasensitive detection of salivary SARS-CoV-2 IgG antibodies in individuals with natural and COVID-19 vaccine-induced immunity
Status: Updated
Description: We assessed the feasibility of a highly sensitive immunoassay method based on single molecule array (Simoa) technology to detect IgG and IgA antibodies against SARS-CoV-2 spike protein receptor binding domain (RBD) in saliva from individuals with natural or vaccine-induced COVID-19 immunity. The performance of the method was compared to a laboratory-developed SARS-CoV-2 RBD total antibody enzyme-linked immunosorbent assay (ELISA). Paired serum and saliva specimens were collected from individuals (n = 40) prior to and 2 weeks after receiving an initial prime COVID-19 vaccine dose (Pfizer/BioNTech BNT162b2 or Moderna mRNA-1273). Saliva was collected using a commercially available collection device (OraSure Inc.) and SARS-CoV-2 RBD IgG antibodies were measured by an indirect ELISA using concentrated saliva samples and a Simoa immunoassay using unconcentrated saliva samples. The IgG results were compared with paired serum specimens that were analyzed for total RBD antibodies using the ELISA method. The analytical sensitivity of the saliva-based Simoa immunoassay was five orders of magnitude higher than the ELISA assay: 0.24 pg/mL compared to 15 ng/mL. The diagnostic sensitivity of the saliva ELISA method was 90% (95% CI 76.3-97.2%) compared to 91.7% (95% CI 77.5-98.2%) for the Simoa immunoassay without total IgG-normalization and 100% (95% CI 90.3-100%) for the Simoa immunoassay after total IgG-normalization when compared to the serum ELISA assay. When analyzed using the SARS-CoV-2 RBD IgG antibody ELISA, the average relative increase in antibody index (AI) between the saliva of the post- and pre-vaccinated individuals was 8.7 (AIpost/pre). An average relative increase of 431 pg/mL was observed when the unconcentrated saliva specimens were analyzed using the Simoa immunoassay (SARS-CoV-2 RBD IgGpost/pre). These findings support the suitability of concentrated saliva specimens for the measurement of SARS-CoV-2 RBD IgG antibodies via ELISA, and unconcentrated saliva specimens for the measurement of SARS-CoV-2 RBD IgG and IgA using an ultrasensitive Simoa immunoassay
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center- University of Minnesota
DOI: 10.21430/M3VWJ6W5M3
Subjects: 0
Study PI, contact:
NameOrganizationSite
Stefani Thomas University of Minnesota University of Minnesota
Amy Karger University of Minnesota University of Minnesota
Bharat Thyagarajan University of Minnesota University of Minnesota
Publications:
Ultrasensitive detection of salivary SARS-CoV-2 IgG antibodies in individuals with natural and COVID-19 vaccine-induced immunity.. Scientific reports May 2022. doi: 10.1038/s41598-022-12869-z [Pubmed: 35614113]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2339: Nplate® PK/PD Study with or without Neulasta® in Rhesus Macaque
Status: Updated
Description: Vehicle, Nplate®, and/or Neulasta® was administered by subcutaneous injection to Co-60 irradiated animals (target LD30/45). Animals received either a single dose of Nplate at 2.5 mg/kg or 5 mg/kg, two doses of Nplate at 5 mg/kg 7 days apart, a single dose of Neulasta at 0.3 mg/kg 7 days apart, a single dose of Nplate at 5 mg/kg and two doses of Neulasta at 0.3 mg/kg 7 days apart, or vehicle. Administration of Nplate, Neulasta and/or vehicle began 24 hours ± 2 hours post irradiation. Hematology was compared among the groups and to vehicle control. Secondary endpoints, such as survival and clinical signs, were included. Pharmacokinetics of Nplate in the various Nplate-treated groups was studies. The vehicle control group contained 5 males and 5 females. All other groups contained 4 males and 4 females. Note: Day 1 is 24 hours after the day of irradiation, which is designated in the data files as Day -1. There is no Day 0. Keywords: rhesus macaques, macaca mulatta, radiation, radiation sickness, hematopoietic, hematology, romiplostim, platelet, thrombocytopenia, pharmacokinetics, pharmacodynamics, drug therapy
Program/Contract:
ProgramContract
Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services Contract Opportunity for Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services
DOI: 10.21430/M3Z6JX4CZ3
Subjects: 50
Study PI, contact:
NameOrganizationSite
Polly Chang SRI International SRI International
Publications:
Pharmacodynamics of romiplostim alone and in combination with pegfilgrastim on acute radiation-induced thrombocytopenia and neutropenia in non-human primates.. International journal of radiation biology Jan 2020. doi: 10.1080/09553002.2019.1625488 [Pubmed: 31216213]
Resources:
Assays:None
Clinical Assessments:None

SDY2356: The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization
Status: Updated
Description: In October 2020, the National Cancer Institute (NCI) Serological Sciences Network (SeroNet) was established to study the immune response to COVID-19, and ""to develop, validate, improve, and implement serological testing and associated technologies"" (https://www.cancer.gov/research/key-initiatives/covid-19/coronavirus-research-initiatives/serological-sciences-network). SeroNet is comprised of 25 participating research institutions partnering with the Frederick National Laboratory for Cancer Research (FNLCR) and the SeroNet Coordinating Center. Since its inception, SeroNet has supported collaborative development and sharing of COVID-19 serological assay procedures and has set forth plans for assay harmonization. To facilitate collaboration and procedure sharing, a detailed survey was sent to collate comprehensive assay details and performance metrics on COVID-19 serological assays within SeroNet. In addition, FNLCR established a protocol to calibrate SeroNet serological assays to reference standards, such as the U.S. severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology standard reference material and first WHO international standard (IS) for anti-SARS-CoV-2 immunoglobulin (20/136), to facilitate harmonization of assay reporting units and cross-comparison of study data. SeroNet institutions reported development of a total of 27 enzyme-linked immunosorbent assay (ELISA) methods, 13 multiplex assays, and 9 neutralization assays and use of 12 different commercial serological methods. FNLCR developed a standardized protocol for SeroNet institutions to calibrate these diverse serological assays to reference standards. In conclusion, SeroNet institutions have established a diverse array of COVID-19 serological assays to study the immune response to SARS-CoV-2 and vaccines. Calibration of SeroNet serological assays to harmonize results reporting will facilitate future pooled data analyses and study cross-comparisons. IMPORTANCE SeroNet institutions have developed or implemented 61 diverse COVID-19 serological assays and are collaboratively working to harmonize these assays using reference materials to establish standardized reporting units. This will facilitate clinical interpretation of serology results and cross-comparison of research data.
Program/Contract:
ProgramContract
SeroNet North Carolina Seronet Center for Excellence
SeroNet High-Throughput Dried Blood Spot (HT-DBS) Technologies in SARS COV-2 Serology and Vaccinology
SeroNet Culturally-targeted communication to promote SARS-CoV-2 antibody testing in saliva: Enabling evaluation of inflammatory pathways in COVID-19 racial disparities
SeroNet Adaptive Immunity and Persistent SARS-CoV-2 Replication
SeroNet Early Drivers of Humoral Immunity to SARS-CoV-2 Infections
SeroNet DISCOVAR:Disparities in Immune Response to SARS-CoV-2 in Arkansas
SeroNet SARS-CoV-2 correlates of protection in a Latino-origin population
SeroNet Johns Hopkins Excellence in Pathogenesis and Immunity Center for SARS-CoV-2 (JH-EPICS)
SeroNet Diversity and Determinants of the Immune-Inflammatory Response to SARS-CoV-2
SeroNet Immune Regulation of COVID-19 Infection in Cancer and Autoimmunity
SeroNet Center for Serological Testing to Improve Outcomes from Pandemic COVID-19 (STOP-COVID)
SeroNet Enhancing racial and ethnic diversity in COVID-19 research participation through storytelling (COVIDstory)
SeroNet Serological Sciences Network Capacity Building Center- University of Minnesota
DOI: 10.21430/M33Q07AHU9
Subjects: 0
Study PI, contact:
NameOrganizationSite
Sabra Klein Johns Hopkins University The Johns Hopkins Bloomberg School of Public Health
James Brien Saint Louis University Saint Louis University
Amy Karger University of Minnesota University of Minnesota
Santosh Dhakal The Johns Hopkins Bloomberg School of Public Health The Johns Hopkins Bloomberg School of Public Health
John Roback Emory University School of Medicine Emory University
Prem Lakshmanane University of North Carolina University of North Carolina
Raquel Binder University of Massachusetts Chan Medical School University of Massachusetts Chan Medical School
Karl Boehme University of Arkansas For Medical Sciences University of Arkansas For Medical Sciences
Suresh Boppana University of Alabama at Birmingham University of Alabama at Birmingham
Carlos Cordon-cardo Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
James Crawford Donald And Barbara Zucker School of Medicine at Hofstra/northwell Donald And Barbara Zucker School of Medicine at Hofstra/northwell
Troy Kemp Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Ligia Pinto Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Adolfo Firpo-betancourt Mount Sinai Mount Sinai
Catherine Forconi University of Massachusetts Medical Center University of Massachusetts Medical Center
Craig Forrest University of Arkansas For Medical Sciences University of Arkansas For Medical Sciences
Douglas Granger Uc-irvine/salimetrics Uc-irvine/salimetrics
Steve Granger Salimetrics, Llc Salimetrics, Llc
Chris Heaney Johns Hopkins University Johns Hopkins University
Christopher King Case Western Reserve University Case Western Reserve University
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Joshua Labaer Arizona State University Arizona State University
Frances Eun-hyung Lee Emory University Emory University
William Lee Wadsworth Center, Ny State Dep Health Wadsworth Center, Ny State Dep Health
Shan-lu Liu The Ohio State University The Ohio State University
Gerard Lozanski The Ohio State University Medical Center The Ohio State University Medical Center
Todd Lucas Michigan State University Michigan State University
Damodara Rao Mendu Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Ann Moormann University of Massachusetts Medical School University of Massachusetts Medical School
Vel Murugan Arizona State University Arizona State University
Petraleigh Pantoja University of Puerto Rico University of Puerto Rico
Jin Park Arizona State University Arizona State University
Swetha Pinninti University of Alabama at Birmingham University of Alabama at Birmingham
Amelia Pinto St. Louis University St. Louis University
Carlos Sariol University of Puerto Rico University of Puerto Rico
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Linda Styer Wadsworth Center, Ny State Dep Health Wadsworth Center, Ny State Dep Health
Mehul Suthar Emory University Emory University
Stefani Thomas University of Minnesota University of Minnesota
Bharat Thyagarajan University of Minnesota University of Minnesota
Ania Wajnberg Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Jennifer Yates Wadsworth Center, Ny State Dep Health Wadsworth Center, Ny State Dep Health
Kimia Sobhani Cedars-sinai Medical Center Cedars-sinai Medical Center
Publications:
The Serological Sciences Network (SeroNet) for COVID-19: Depth and Breadth of Serology Assays and Plans for Assay Harmonization.. mSphere Aug 2022. doi: 10.1128/msphere.00193-22 [Pubmed: 35703544]
Resources:
Assays:None
Clinical Assessments:None

SDY2393: Rhesus H-ARS Dose-Response Relationship
Status: Updated
Description: Rhesus macaques (Macaca mulatta) were exposed to total-body irradiation ranging from 500 cGy to 750 cGy at a dose rate of 50 cGy/min from a Co-60 source and were observed for 60 days for mortality and clinical signs. Each group consisted of 4 males and 4 females. Animals were provided with supportive care which included antibiotics, fluids, anti-ulcer, anti-emetics, analgesics, nutritional support, and wound disinfection administered according to pre-determined criteria, but were not provided blood transfusions. Blood was drawn at predetermined time points and blood cells were counted. Note: Day 1 is 24 hours after the day of irradiation, which is designated in the data files as Day -1. There is no Day 0. Keywords: rhesus macaques, radiation, natural history, radiation sickness, hematopoietic, hematology, proteomics, metabolomics
Program/Contract:
ProgramContract
Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services Contract Opportunity for Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services
DOI: 10.21430/M3ZAEP8Q6S
Subjects: 48
Study PI, contact:
NameOrganizationSite
Polly Chang SRI International SRI Internation
Publications:
Total body irradiation models in NHPs - consideration of animal sex and provision of supportive care to advance model development.. International journal of radiation biology Jan 2021. doi: 10.1080/09553002.2021.1844335 [Pubmed: 33259246]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Mass Spectrometry 0
Clinical Assessments:None

SDY2491: SARS-CoV-2 serosurvey across multiple waves of the COVID-19 pandemic in New York City between 2020-2023
Status: Updated
Description: Here, the authors describe results of a cross-sectional hospital-based study of anti-spike seroprevalence in New York City (NYC) from February 2020 to July 2022, and a follow-up period from August 2023 to October 2023.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3X08KNYJ3
Subjects: 55092
Study PI, contact:
NameOrganizationSite
Juan Manuel Carreno Icahn School of Medicine at Mount Sinai ISMM_SEM-CIVIC Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Florian Krammer Icahn School of Medicine at Mount Sinai ISMM_SEM-CIVIC Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
SARS-CoV-2 serosurvey across multiple waves of the COVID-19 pandemic in New York City between 2020-2023.. Nature communications Jul 2024. doi: 10.1038/s41467-024-50052-2 [Pubmed: 38992013]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 110174
Clinical Assessments:None

SDY2562: SARS-CoV-2 IgG Spike antibody levels and avidity in natural infection or following vaccination with mRNA-1273 or BNT162b2 vaccines
Status: Updated
Description: Certain aspects of the immunogenicity and effectiveness of the messenger ribonucleic acid (mRNA) vaccines (mRNA-1273 and BNT162b2) developed in response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic are still uncharacterized. Serum or plasma samples from healthy donor recipients of either vaccine (BNT162b2 n = 53, mRNA-1273 n = 49; age 23-67), and individuals naturally infected with SARS-CoV-2 (n = 106; age 18-82) were collected 0-2 months post-infection or 1- and 4 months after second dose of vaccination. Anti-Spike antibody levels and avidity were measured via an enzyme-linked immunosorbent assay (ELISA). Overall, vaccination induced higher circulating anti-Spike protein immunoglobulin G (IgG) antibody levels and avidity compared to infection at similar time intervals. Both vaccines produced similar anti-Spike IgG concentrations at 1 month, while mRNA-1273 demonstrated significantly higher circulating antibody concentrations after 4 months. mRNA-1273 induced significantly higher avidity at month 1 compared to BNT162b2 across all age groups. However, the 23-34 age group was the only group to maintain statistical significance by 4 months. Male BNT162b2 recipients were approaching statistically significant lower anti-Spike IgG avidity compared to females by month 4. These findings demonstrate enhanced anti-Spike IgG levels and avidity following vaccination compared to natural infection. In addition, the mRNA-1273 vaccine induced higher antibody levels by 4 months compared to BNT162b2.
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/m3la0cdz9l
Subjects: 0
Study PI, contact:
NameOrganizationSite
Troy Kemp National Institutes of Health Frederick National Laboratory For Cancer Research
Thomas Hickey National Institutes of Health Frederick National Laboratory For Cancer Research
Ligia Pinto National Institutes of Health Frederick National Laboratory For Cancer Research
Publications:
SARS-CoV-2 IgG Spike antibody levels and avidity in natural infection or following vaccination with mRNA-1273 or BNT162b2 vaccines.. Human vaccines & immunotherapeutics Aug 2023. doi: 10.1080/21645515.2023.2215677 [Pubmed: 37264688]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2565: Evidence for retained spike-binding and neutralizing activity against emerging SARS-CoV-2 variants in serum of COVID-19 mRNA vaccine recipients
Status: Updated
Description: Background: Highly efficacious vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed. However, the emergence of viral variants that are more infectious than the earlier SARS-CoV-2 strains is concerning. Several of these viral variants have the potential to partially escape neutralizing antibody responses, warranting continued immune-monitoring. Methods: We used a panel of 30 post-mRNA vaccination sera to determine neutralization and RBD and spike binding activity against a number of emerging viral variants. The virus neutralization was determined using authentic SARS-CoV-2 clinical isolates in an assay format that mimics physiological conditions. Findings: We tested seven currently circulating viral variants of concern/interest, including the three Iota sublineages, Alpha (E484K), Beta, Delta and Lambda in neutralization assays. We found only small decreases in neutralization against Iota and Delta. The reduction was stronger against a sub-variant of Lambda, followed by Beta and Alpha (E484K). Lambda is currently circulating in parts of Latin America and was detected in Germany, the US and Israel. Of note, reduction in a receptor binding domain and spike binding assay that also included Gamma, Kappa and A.23.1 was negligible. Interpretation: Taken together, these findings suggest that mRNA SARS-CoV-2 vaccines may remain effective against these viral variants of concern/interest and that spike binding antibody tests likely retain specificity in the face of evolving SARS-CoV-2 diversity.
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/m35sd2inua
Subjects: 0
Study PI, contact:
NameOrganizationSite
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Komal Srivastava Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Evidence for retained spike-binding and neutralizing activity against emerging SARS-CoV-2 variants in serum of COVID-19 mRNA vaccine recipients.. EBioMedicine Nov 2021. doi: 10.1016/j.ebiom.2021.103626 [Pubmed: 34688034]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Neutralizing Antibody Titer Assay 0
Clinical Assessments:None

SDY2608: mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations
Status: Updated
Description: In this study, we determined if any of the components of mRNA-1273 or BNT162b2 formulations elicited PEG-specific antibody responses in serum by enzyme linked immunosorbent assay (ELISA). Using sera from participants selected based on the vaccine-associated side effects experienced after vaccination, including delayed onset, injection site or severe allergic reactions, we found no obvious association between PEG antibodies and adverse reactions.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M393Q1VZXO
Subjects: 133
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations.. Vaccine Oct 2022. doi: 10.1016/j.vaccine.2022.08.024 [Pubmed: 36115801]
Resources:
Not Applicable Not Applicable]
Link to SeroNet SDY2796 https://immport.org/shared/study/SDY2796]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 532
Clinical Assessments:None

SDY2653: Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial
Status: Updated
Description: Background: Cancer patients show increased morbidity with COVID-19 and need effective immunization strategies. Many healthcare regulatory agencies recommend administering 'booster' doses of COVID-19 vaccines beyond the standard two-dose series, for this group of patients. Therefore, studying the efficacy of these additional vaccine doses against SARS-CoV-2 and variants of concern is of utmost importance in this immunocompromised patient population. Methods: We conducted a prospective single arm clinical trial enrolling patients with cancer that had received two doses of mRNA or one dose of AD26.CoV2.S vaccine and administered a third dose of mRNA vaccine. We further enrolled patients that had no or low responses to three mRNA COVID vaccines and assessed the efficacy of a fourth dose of mRNA vaccine. Efficacy was assessed by changes in anti-spike antibody, T-cell activity, and neutralization activity, which were again assessed at baseline and 4 weeks. Results: We demonstrate that a third dose of COVID-19 vaccine leads to seroconversion in 57% of patients that were seronegative after primary vaccination series. The immune response is durable as assessed by anti-SARS-CoV-2 (anti-S) antibody titers, T-cell activity, and neutralization activity against wild-type (WT) SARS-CoV2 and BA1.1.529 at 6 months of follow-up. A subset of severely immunocompromised hematologic malignancy patients that were unable to mount an adequate immune response (titer <1000 AU/mL) after the third dose and were treated with a fourth dose in a prospective clinical trial which led to adequate immune boost in 67% of patients. Low baseline IgM levels and CD19 counts were associated with inadequate seroconversion. Booster doses induced limited neutralization activity against the Omicron variant. Conclusions: These results indicate that third dose of COVID vaccine induces durable immunity in cancer patients and an additional dose can further stimulate immunity in a subset of patients with inadequate response.
Program/Contract:
ProgramContract
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3X4DFJ39H
Subjects: 0
Study PI, contact:
NameOrganizationSite
Balazs Halmos Albert Einstein College of Medicine Albert Einstein College of Medicine
Amit Verma Albert Einstein College of Medicine Albert Einstein College of Medicine
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial.. eLife Mar 2023. doi: 10.7554/eLife.83694 [Pubmed: 36975207]
Resources:
CovidBooster code used to analyse booster efficacy. https://github.com/kith-pradhan/CovidBooster]
CovidBooster4th code used to study 2nd booster efficacy https://github.com/kith-pradhan/CovidBooster4th]
Booster Dose Trial info at ClinicalTrials.gov https://clinicaltrials.gov/study/NCT05016622]
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
ELISA 0
Plaque Reduction Neutralization Assay 0
Pseudovirus Neutralization Assay 0
Clinical Assessments:None

SDY2677: Highly variable SARS-CoV-2 spike antibody responses to two doses of COVID-19 RNA vaccination in patients with multiple myeloma
Status: Updated
Description: COVID-19 mRNA vaccines are highly efficacious in preventing COVID-19 morbidity and mortality in phase 3 clinical studies as well as in real-world settings. Emerging evidence suggests that some individuals with underlying comorbidities may mount suboptimal antibody responses to SARS-CoV-2 immunization (Addeo et al., 2021; Monin et al., 2021; Thakkar et al., 2021). Indeed, patients with multiple myeloma (MM) are immuno-compromised due to defects in humoral and cellular immunity as well as due to immunosuppressive therapy. Preliminary reports indicate that the antibody response in MM after the initial dose of SARS-CoV-2 mRNA vaccine is attenuated and delayed compared to healthy controls (Bird et al., 2021; Terpos et al., 2021). Moreover, MM patients who receive anti-CD38 monoclonal antibodies may have poorer vaccine-induced antibody responses even after completion of the full two-dose mRNA vaccine regimen (Pimpinelli et al., 2021). The kinetics of the vaccine responses in MM patients with prior COVID-19 infection and the impact of treatments, including BCMA-targeting agents, to vaccine response remain unknown.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3JYPNNBD2
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ania Wajnberg Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Carlos Cordon-cardo Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Komal Srivastava Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Charles Gleason Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Highly variable SARS-CoV-2 spike antibody responses to two doses of COVID-19 RNA vaccination in patients with multiple myeloma.. Cancer cell Aug 2021. doi: 10.1016/j.ccell.2021.06.014 [Pubmed: 34242572]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2722: Selection, Characterization, Calibration, and Distribution of the U.S. Serology Standard for Anti-SARS-CoV-2 Antibody Detection
Status: Updated
Description: The SARS-CoV-2 pandemic resulted in a demand for highly specific and sensitive serological testing to evaluate seroprevalence and antiviral immune responses to infection and vaccines. Hence, there was an urgent need for a serology standard to harmonize results across different natural history and vaccine studies. The Frederick National Laboratory for Cancer Research (FNLCR) generated a U.S. serology standard for SARS-CoV-2 serology assays and subsequently calibrated it to the WHO international standard (National Institute for Biological Standards and Control [NIBSC] code 20/136) (WHO IS). The development included a collaborative study to evaluate the suitability of the U.S. serology standard as a calibrator for SARS-CoV-2 serology assays. The eight laboratories participating in the study tested a total of 17 assays, which included commercial and in-house-derived binding antibody assays, as well as neutralization assays. Notably, the use of the U.S. serology standard to normalize results led to a reduction in the inter-assay coefficient of variation (CV) for IgM levels (pre-normalization range, 370.6% to 1,026.7%, and post-normalization range, 52.8% to 242.3%) and a reduction in the inter-assay CV for IgG levels (pre-normalization range, 3,416.3% to 6,160.8%, and post-normalization range, 41.6% to 134.6%). The following results were assigned to the U.S. serology standard following calibration against the WHO IS: 246 binding antibody units (BAU)/mL for Spike IgM, 764 BAU/mL for Spike IgG, 1,037 BAU/mL for Nucleocapsid IgM, 681 BAU/mL for Nucleocapsid IgG assays, and 813 neutralizing international units (IU)/mL for neutralization assays. The U.S. serology standard has been made publicly available as a resource to the scientific community around the globe to help harmonize results between laboratories.
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/M3L0AGMHT3
Subjects: 0
Study PI, contact:
NameOrganizationSite
Troy Kemp Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Jack Quesinberry Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Jim Cherry National Cancer Institute National Cancer Institute
Douglas Lowy National Cancer Institute National Cancer Institute
Ligia Pinto Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Publications:
Selection, Characterization, Calibration, and Distribution of the U.S. Serology Standard for Anti-SARS-CoV-2 Antibody Detection.. Journal of clinical microbiology Nov 2022. doi: 10.1128/jcm.00995-22 [Pubmed: 36222529]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2723: Development, Validation, and Utilization of a Luminex-Based SARS-CoV-2 Multiplex Serology Assay
Status: Updated
Description: SARS-CoV-2 antibody testing is important for seroprevalence studies and for evaluating vaccine immune responses. We developed and validated a Luminex bead-based multiplex serology assay for measuring IgG levels of anti-SARS-CoV-2 antibodies against full-length spike (S), nucleocapsid (N), and receptor-binding domains (RBDs) of wild-type, RBD N501Y mutant, RBD E484K mutant, RBD triple mutant SARS-CoV-2 proteins, Sars-CoV-1, MERS-CoV, and common human coronaviruses, including SARS-CoV-2, OC43, 229E, HKU1, and NL63. Assay cutoff values, sensitivity, and specificity were determined using samples from 160 negative controls and 60 PCR-confirmed, SARS-CoV-2-infected individuals. The assay demonstrated sensitivities of 98.3%, 95%, and 100% and specificities of 100%, 99.4%, and 98.8% for anti-(S), -N, and -RBD, respectively. Results are expressed as IgG antibody concentrations in BAU/mL, using the WHO international standard (NIBSC code 20/136) for anti-SARS-CoV-2 IgG antibodies. When the multiplex assay was performed and compared with singleplex assays, the IgG antibody measurement geometric mean ratios were between 0.895 and 1.122, and no evidence of interference was observed between antigens. Lower and upper IgG concentration limits, based on accuracy (between 80% and 120%), precision (percent relative standard deviation, ≤25%), and sample dilutional linearity (between 75% and 125%), were used to establish the assay range. Precision was established by evaluating 24 individual human serum samples obtained from vaccinated and SARS-CoV-2-infected individuals. The assay provided reproducible, consistent results with typical coefficients of variation of ≤20% for all assays, irrespective of the run, day, or analyst. Results indicate the assay has high sensitivity and specificity and thus is appropriate for use in measuring SARS-CoV-2 IgG antibodies in infected and vaccinated individuals. IMPORTANCE The SARS-CoV-2 pandemic resulted in the development and validation of multiple serology tests with variable performance. While there are multiple SARS-CoV-2 serology tests to detect SARS-CoV-2 antibodies, the focus is usually either on only one antigen at a time or multiple proteins from only one SARS-CoV-2 variant. These tests usually do not evaluate antibodies against viral proteins from different SARS-CoV-2 variants or from other coronaviruses. Here, we evaluated a multiplex serology test based on Luminex technology, where antibodies against multiple domains of SARS-CoV-2 wild type, SARS-CoV-2 mutants, and common coronavirus antibodies are detected simultaneously in a single assay. This Luminex-based multiplex serology assay can enhance our understanding of the immune response to SARS-CoV-2 infection and vaccination.
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/M3NXSR3X2R
Subjects: 0
Study PI, contact:
NameOrganizationSite
Troy Kemp Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Pinto Ligia Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Haynesworth Katarzyna Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Publications:
Development, Validation, and Utilization of a Luminex-Based SARS-CoV-2 Multiplex Serology Assay.. Microbiology spectrum Mar 2023. doi: 10.1128/spectrum.03898-22 [Pubmed: 36927068]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Multiplex Bead Array Assay 0
Clinical Assessments:None

SDY2726: A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays
Status: Updated
Description: The emergence of SARS-CoV-2 created a crucial need for serology assays to detect anti-SARS-CoV-2 antibodies, which led to many serology assays entering the market. A trans-government collaboration was created in April 2020 to independently evaluate the performance of commercial SARS-CoV-2 serology assays and help inform U.S. Food and Drug Administration (FDA) regulatory decisions. To assess assay performance, three evaluation panels with similar antibody titer distributions were assembled. Each panel consisted of 110 samples with positive (n = 30) serum samples with a wide range of anti-SARS-CoV-2 antibody titers and negative (n = 80) plasma and/or serum samples that were collected before the start of the COVID-19 pandemic. Each sample was characterized for anti-SARS-CoV-2 antibodies against the spike protein using enzyme-linked immunosorbent assays (ELISA). Samples were selected for the panel when there was agreement on seropositivity by laboratories at National Cancer Institute's Frederick National Laboratory for Cancer Research (NCI-FNLCR) and Centers for Disease Control and Prevention (CDC). The sensitivity and specificity of each assay were assessed to determine Emergency Use Authorization (EUA) suitability. As of January 8, 2021, results from 91 evaluations were made publicly available (https://open.fda.gov/apis/device/covid19serology/, and https://www.cdc.gov/coronavirus/2019-ncov/covid-data/serology-surveillance/serology-test-evaluation.html). Sensitivity ranged from 27% to 100% for IgG (n = 81), from 10% to 100% for IgM (n = 74), and from 73% to 100% for total or pan-immunoglobulins (n = 5). The combined specificity ranged from 58% to 100% (n = 91). Approximately one-third (n = 27) of the assays evaluated are now authorized by FDA for emergency use. This collaboration established a framework for assay performance evaluation that could be used for future outbreaks and could serve as a model for other technologies. IMPORTANCE The SARS-CoV-2 pandemic created a crucial need for accurate serology assays to evaluate seroprevalence and antiviral immune responses. The initial flood of serology assays entering the market with inadequate performance emphasized the need for independent evaluation of commercial SARS-CoV-2 antibody assays using performance evaluation panels to determine suitability for use under EUA. Through a government-wide collaborative network, 91 commercial SARS-CoV-2 serology assay evaluations were performed. Three evaluation panels with similar overall antibody titer distributions were assembled to evaluate performance. Nearly one-third of the assays evaluated met acceptable performance recommendations, and two assays had EUAs revoked and were removed from the U.S. market based on inadequate performance. Data for all serology assays evaluated are available at the FDA and CDC websites (https://open.fda.gov/apis/device/covid19serology/, and https://www.cdc.gov/coronavirus/2019-ncov/covid-data/serology-surveillance/serology-test-evaluation.html).
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/M3SK8ANYK1
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ligia Pinto Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research, Frederick, Maryland
Troy Kemp Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research, Frederick, Maryland
Douglas Lowy National Cancer Institute National Cancer Institute, Bethesda, Maryland
Publications:
A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays.. Microbiology spectrum Feb 2022. doi: 10.1128/spectrum.01564-21 [Pubmed: 35019677]
Resources:
GenBank: MN908947.3 https://www.ncbi.nlm.nih.gov/nuccore/MN908947.3]
Open FDA: Independent Evaluations of COVID-19 Serological Tests https://open.fda.gov/apis/device/covid19serology/]
Assays:
Assay TypeNumber of Exp. Samples
Chemiluminescent Assay 0
ELISA 0
Lateral Flow Assay 0
Clinical Assessments:None

SDY2727: Assay Harmonization Study To Measure Immune Response to SARS-CoV-2 Infection and Vaccines: a Serology Methods Study
Status: Updated
Description: The Coronavirus disease 2019 (COVID-19) pandemic presented the scientific community with an immediate need for accurate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology assays, resulting in an expansion of assay development, some without following a rigorous quality control and validation, and with a wide range of performance characteristics. Vast amounts of data have been gathered on SARS-CoV-2 antibody response; however, performance and ability to compare the results have been challenging. This study seeks to analyze the reliability, sensitivity, specificity, and reproducibility of a set of widely used commercial, in-house, and neutralization serology assays, as well as provide evidence for the feasibility of using the World Health Organization (WHO) International Standard (IS) as a harmonization tool. This study also seeks to demonstrate that binding immunoassays may serve as a practical alternative for the serological study of large sample sets in lieu of expensive, complex, and less reproducible neutralization assays. In this study, commercial assays demonstrated the highest specificity, while in-house assays excelled in antibody sensitivity. As expected, neutralization assays demonstrated high levels of variability but overall good correlations with binding immunoassays, suggesting that binding may be reasonably accurate as well as practical for the study of SARS-CoV-2 serology. All three assay types performed well after WHO IS standardization. The results of this study demonstrate there are high performing serology assays available to the scientific community to rigorously dissect antibody responses to infection and vaccination. IMPORTANCE Previous studies have shown significant variability in SARS-CoV-2 antibody serology assays, highlighting the need for evaluation and comparison of these assays using the same set of samples covering a wide range of antibody responses induced by infection or vaccination. This study demonstrated that there are high performing assays that can be used reliably to evaluate immune responses to SARS-CoV-2 in the context of infection and vaccination. This study also demonstrated the feasibility of harmonizing these assays against the International Standard and provided evidence that the binding immunoassays may have high enough correlation with the neutralization assays to serve as a practical proxy. These results represent an important step in standardizing and harmonizing the many different serological assays used to evaluate COVID-19 immune responses in the population.
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/M3OL8R66OB
Subjects: 0
Study PI, contact:
NameOrganizationSite
Troy Kemp Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Jim Cherry National Cancer Institute National Cancer Institute
Douglas Lowy National Institute of Allergy And Infectious Diseases National Institute of Allergy And Infectious Diseases
Ligia Pinto Frederick National Laboratory For Cancer Research Frederick National Laboratory For Cancer Research
Publications:
Assay Harmonization Study To Measure Immune Response to SARS-CoV-2 Infection and Vaccines: a Serology Methods Study.. Microbiology spectrum Jun 2023. doi: 10.1128/spectrum.05353-22 [Pubmed: 37191544]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Multiplex Immunoassay 0
Neutralizing Antibody Titer Assay 0
Clinical Assessments:None

SDY2728: Longitudinal Assessment of BNT162b2- and mRNA-1273-Induced Anti-SARS-CoV-2 Spike IgG Levels and Avidity Following Three Doses of Vaccination
Status: Updated
Description: SARS-CoV-2 vaccination-induced protection against infection is likely to be affected by functional antibody features. To understand the kinetics of antibody responses in healthy individuals after primary series and third vaccine doses, sera from the recipients of the two licensed SARS-CoV-2 mRNA vaccines were assessed for circulating anti-SARS-CoV-2 spike IgG levels and avidity for up to 6 months post-primary series and 9 months after the third dose. Following primary series vaccination, anti-SARS-CoV-2 spike IgG levels declined from months 1 to 6, while avidity increased through month 6, irrespective of the vaccine received. The third dose of either vaccine increased anti-SARS-CoV-2 spike IgG levels and avidity and appeared to enhance antibody level persistence— generating a slower rate of decline in the 3 months following the third dose compared to the decline seen after the primary series alone. The third dose of both vaccines induced significant avidity increases 1 month after vaccination compared to the avidity response 6 months post-primary series vaccination (p ≤ 0.001). A significant difference in avidity responses between the two vaccines was observed 6 months post-third dose, where the BNT162b2 recipients had higher antibody avidity levels compared to the mRNA-1273 recipients (p = 0.020).
Program/Contract:
ProgramContract
SeroNet Frederick National Laboratory for Cancer Research COVID-19 Serology Laboratory
DOI: 10.21430/M36Q446TZ2
Subjects: 0
Study PI, contact:
NameOrganizationSite
Jimmie Bullock Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Thomas Hickey Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Troy Kemp Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Jordan Metz Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Sarah Loftus Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Katarzyna Haynesworth Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Nicholas Castro Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Brian Luke Frederick National Laboratory For Cancer Research Bioinformatics And Computational Science Directorate
Douglas Lowy National Cancer Institute Laboratory of Cellular Oncology
Ligia Pinto Frederick National Laboratory For Cancer Research Vaccine, Immunity And Cancer Directorate
Publications:
Longitudinal Assessment of BNT162b2- and mRNA-1273-Induced Anti-SARS-CoV-2 Spike IgG Levels and Avidity Following Three Doses of Vaccination.. Vaccines May 2024. doi: 10.3390/vaccines12050516 [Pubmed: 38793767]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 0
Clinical Assessments:None

SDY2761: Cellular mechanisms associated with sub-optimal immune responses to SARS-CoV-2 bivalent booster vaccination in patients with Multiple Myeloma
Status: Updated
Description: Spike binding IgG antibody levels were measured by spike binding ELISA and neutralization capacity was assessed by SARS-CoV-2 multi-cycle microneutralization assays. Spike specific T-cell function was also assessed. Flow cytometry was performed, on a subset of samples, to identify immune cell subsets associated with lack of humoral antibodies.
Program/Contract:
ProgramContract
NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) New York Influenza Center of Excellence
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
NIH Program DYNAMICS AND EVOLUTION OF IMMUNE RESPONSES TO INFLUENZA VIRUSES
DOI: 10.21430/M3KF4UNHV8
Subjects: 0
Study PI, contact:
NameOrganizationSite
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Komal Srivastava Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Charles Gleason Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Cellular mechanisms associated with sub-optimal immune responses to SARS-CoV-2 bivalent booster vaccination in patients with Multiple Myeloma.. EBioMedicine Dec 2023. doi: 10.1016/j.ebiom.2023.104886 [Pubmed: 37995467]
Resources:
Assays:None
Clinical Assessments:None

SDY2824: SARS-CoV-2 vaccination induces mucosal antibody responses in previously infected individuals
Status: Updated
Description: Here we analyze paired serum and saliva samples from patients with and without prior coronavirus disease 2019 (COVID-19) at multiple time points pre and post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccination
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3C3RLCVLT
Subjects: 29
Study PI, contact:
NameOrganizationSite
Viviana Simon Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
SARS-CoV-2 vaccination induces mucosal antibody responses in previously infected individuals.. Nature communications Sep 2022. doi: 10.1038/s41467-022-32389-8 [Pubmed: 36050304]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 830
Clinical Assessments:
Serology

SDY2838: Binding and Avidity Signatures of Polyclonal Sera From Individuals With Different Exposure Histories to Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Vaccination, and Omicron Breakthrough Infections.
Status: Updated
Description: Here, the investigators explored how different exposures to SARS-CoV-2 infection or vaccination influence the polyclonal immune response.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
SeroNet Serological Sciences Network Capacity Building Center - Icahn School of Medicine at Mount Sinai
DOI: 10.21430/M3X11RM5CN
Subjects: 105
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
Binding and Avidity Signatures of Polyclonal Sera From Individuals With Different Exposure Histories to Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Vaccination, and Omicron Breakthrough Infections.. The Journal of infectious diseases Aug 2023. doi: 10.1093/infdis/jiad116 [Pubmed: 37104046]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 987
Virus Neutralization 34
Clinical Assessments:
Breakthrough_Infection_History
SARS-CoV-2_History