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DR66 DataRelease

Release Date: June 2026
New Studies: 24
Updated Studies: 12

New Studies

SDY2697: Investigation of booster vaccination of a novel HydroVax-panH1N1 vaccine
Status: New
Description: To investigate the impact of booster vaccination on the magnitude, durability, breadth, and protective efficacy of a novel HydroVax-panH1N1 vaccine.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M36RRNL51Q
Subjects: 17
Study PI, contact:
NameOrganizationSite
Ian Amanna Najit Technologies, Inc. Najit Technologies, Inc., Duke CIVICs Vaccine Center (DCVC)
Gregory Sempowski Duke University Duke University, Duke CIVICs Vaccine Center (DCVC)
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:
Physical Exam
Release Notes:
NA

SDY3101: Robust SARS-CoV-2-neutralizing antibodies sustained through 6 months post XBB.1.5 mRNA vaccine booster
Status: New
Description: Here, the investigators perform neutralization assays on four viral variants (D614G, BA.5, XBB.1.5, and JN.1) using sera from participants obtained at 1 month, 3 months, and 6 months post an XBB.1.5 MV booster.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M37GRQSCWI
Subjects: 92
Study PI, contact:
NameOrganizationSite
Aubree Gordon University of Michigan University of Michigan, Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
Publications:
Robust SARS-CoV-2-neutralizing antibodies sustained through 6 months post XBB.1.5 mRNA vaccine booster.. Cell reports. Medicine Sep 2024. doi: 10.1016/j.xcrm.2024.101701 [Pubmed: 39208800]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
Virus Neutralization 696
Clinical Assessments:
Infection-History-1
Infection-History-2
Release Notes:
NA

SDY3261: RINSC vs RARAF Neutrons
Status: New
Description: In the radiation biodosimetry field, transcriptomics studies seek to determine whether the expression of a small set of genes can be used to estimate the radiation dose that a person was exposed to. Most such studies consider only photon exposure, but in the detonation of an improvised nuclear device, neutrons would likely comprise a significant proportion of the dose. In this study, we compare the effects on gene expression in human blood between two neutron-producing radiation sources: a source designed to mimic the output of a nuclear weapon (the Columbia University Neutron Facility at the Radiological Research Acceleration Facility) and a source from a nuclear reactor (the Rhode Island Nuclear Science Center). The radiation sources have very different neutron energy spectra: mainly fast neutrons (Columbia source) versus thermal neutrons (Rhode Island source). Differential gene expression suggests that the fast neutron response comprises the thermal neutron response, plus an additional component, both in terms of number of differentially expressed genes and an analysis for overrepresented gene sets. This may be caused by the difference in neutron energies. An analysis of overrepresented gene sets using genes found to be correlated with radiation dose suggests a much more similar response between the results from the two different facilities with a difference in magnitude.
Program/Contract:
ProgramContract
Centers for Medical Countermeasures Against Radiation Consortium (CMCRC) RFA-AI-19-012 Center For High-Throughput Minimally-Invasive Radiation Biodosimetry RFA-AI-19-012
NIH Program Center for High-Throughput Minimally-Invasive Radiation Biodosimetry
DOI: 10.21430/M3X8YHSIYQ
Subjects: 12
Study PI, contact:
NameOrganizationSite
Michael Antosh University of Rhode Island University of Rhode Island
Sally Amundson Columbia University Irving Medical Center Columbia University Irving Medical Center
Publications:
Gene expression as a biological dosimeter: effects of different neutron energies.. Radiation and environmental biophysics Jul 2026. doi: 10.1007/s00411-026-01237-4 [Pubmed: 42440102]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Bulk RNA-seq assay 120
Clinical Assessments:None
Release Notes:
NA

SDY3322: 5 HA mRNA Candidate Data Package
Status: New
Description: We designed an mRNA-LNP vaccine expressing 5 HAs instead of 20 HAs. This 5 HA mRNA-LNP will be used in a Phase 1 clinical study. This vaccine encodes H1, H2, H3, H5, and H7 immunogens. We updated the H1, H3, H5, and H7 components relative to the respective components of the 20 HA mRNA-LNP vaccine. For initial pre-clinical immunogenicity studies, we created 5 separate monovalent HA mRNA-LNP and mixed these LNPs prior to vaccination. This was the same procedure that was used for our 20 HA mRNA-LNP pre-clinical studies.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M35VOTL4RZ
Subjects: 47
Study PI, contact:
NameOrganizationSite
Scott Hensley University of Pennsylvania University of Pennsylvania, Duke CIVICs Vaccine Center (DCVC)
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:
Not Applicable
Release Notes:
NA

SDY3353: Human Immune Responses to Different Covid-19 Vaccines
Status: New
Description: mRNA vaccines, administered in two doses, have been very effective against SARS-CoV-2 and are considered for broader vaccine applications. However, the development of human innate immune responses to these novel vaccines remains incompletely understood. Here, we profiled immune responses to Pfizer’s BNT162b2Ò (n=22) and Moderna’s mRNA-1273Ò (n=6), compared to J&J’s adenoviral vector vaccine Ad26.COV2.SÒ (n=3), using longitudinal single-cell profiling of peripheral blood mononuclear cells (PBMCs). The first dose of the mRNA vaccines induced a unique interferon state (ISGdim) in monocytes and dendritic cells, marked by upregulation of MX1, MX2, DDX58 (RIG-I), and other genes regulated by the ISGF3 (Interferon-Stimulated Gene Factor 3) complex. This ISGdim state transitioned into a full interferon-stimulated gene state (ISGhigh) after the second dose, characterized by the upregulation of additional interferon-responsive genes (e.g., XXX). In vitro experiments revealed that while the ISGdim state is driven by endogenous IFN-α production, IFN-γ is required to establish the ISGhigh state. Collectively, this study provides key insights into the stepwise development of innate immune responses to mRNA vaccines in human myeloid cells.
Program/Contract:
ProgramContract
NIH Program High-resolution single cell profiling of vaccine responsiveness in the elderly
DOI: 10.21430/M3NPY1LH69
Subjects: 32
Study PI, contact:
NameOrganizationSite
Duygu Ucar The Jackson Laboratory for Genomic Medicine The Jackson Laboratory for Genomic Medicine
George Kuchel UConn Health UConn Center on Aging, UConn Health
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 78
Clinical Assessments:None
Release Notes:
NA

SDY3439: Gene discovery and expression analysis of the B cell receptor repertoire in the domestic ferret model
Status: New
Description: The domestic ferret is the preferred model organism for the study of influenza A infection and responses to vaccination but has remained underutilized in antibody-omics research to inform vaccine design. This study used a curated set of V(D)J genes from human and closely related carnivores to BLAST the ferret genome to define a reference immunoglobulin repertoire for the ferret. Immunoglobulin transcript expression was analyzed for both variable and constant region genes to identify two functional IGHG genes in the ferret. A publicly available workflow for discovering immunoglobulin genes in any species is now available, as well as a complete ferret immunoglobulin gene set with genomic sequences for 409 heavy and light chain ferret immunoglobulin genes.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M31DN6EGLY
Subjects: 0
Study PI, contact:
NameOrganizationSite
Luke Hebert University of Texas - Austin UTAU_DCVC
Allison Seeger University of Texas - Austin UTAU_DCVC
Publications:
None. None None None. doi: None [Pubmed: Not Applicable]
Resources:
github.com https://github.com/LukeHebert/ig_genes_ferret]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3652: Monitoring radiation exposure through skin swab metabolomic profiling
Status: New
Description: Exposure to ionizing radiation poses major health risks across medical, occupational, and spaceflight settings, driving the need for rapid, non-invasive biodosimetry tools. As the body’s most accessible organ and the most frequent site of radiation injury, the skin represents a promising interface for monitoring exposure. Using murine models, we performed metabolomic profiling on skin swab samples collected after exposure to 0, 1, or 4 Gy of x-rays. We identified two distinct metabolite panels: one discriminating irradiated from non-irradiated skin, and another distinguishing dose-specific response. These panels included conserved radiation-responsive metabolites (e.g., uric acid, xanthine, taurine) and skin-specific markers associated with barrier integrity (e.g., proline, arginine). These findings establish a foundation for non-invasive and real-time skin-based biodosimetry approaches for radiation exposures.
Program/Contract:
ProgramContract
Unassigned Targeted Biomarker Panels and Pre-processing Device for the Rapid Assessment of Radiation Injury in Easily Accessible Biofluids
DOI: 10.21430/M3A2O48ZV7
Subjects: 0
Study PI, contact:
NameOrganizationSite
Evagelia Laiakis Georgetown University Georgetown University
Geraldine Vitry Georgetown University Georgetown University
Publications:None
Resources:
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3682: 17q12-q21 Genotype, Viral Wheezing and Childhood Asthma
Status: New
Description: Early-life viral wheezing illnesses and 17q12-q21 genotypes are associated with childhood asthma. In five cohorts of the Children’s Respiratory and Environmental Workgroup (CREW), we studied the association of 17q12-q21 genotypes with RV and/or RSV virus-specific wheezing in the first three years of life within each of two parent-identified racial groups, White and Black children. We then evaluated 17q12-q21 genotype and virus-specific wheezing on asthma outcomes at ages five to seven years. We assessed how genotype modified associations of viral wheezing illness on the prevalence of asthma stratified by parental asthma history. The rs7216389-TT asthma risk genotype was associated with increased cumulative RV-wheezing events to age three years in White (hazard ratio 1.46 [95%CI: 1.16, 1.85]) but not in Black children; genotype did not increase risk for RSV-wheezing in White or Black children. An interaction effect of rs7216389 genotype RV wheeze on asthma risk was present in Black children (PInt = 0.017) and with RSV wheeze in White children (PInt = 0.018). When stratified by parental asthma there were similar interaction effects of rs7216389 genotype with RV (PInt = 0.046) or RSV (PInt < 0.001) wheezing illnesses on asthma risk only in children without a parental history of asthma. For all interaction effects, the asthma risk genotype at rs7216389 was associated with increased risk of asthma among children without a virus-specific wheezing illness but was associated with lower risk of asthma among children with a virus-specific wheezing illness. Virus induced wheezing illnesses reduced the risk for asthma in certain subgroups of children. 17q12-q21 genotype interactions on asthma risk varied by race, virus-strain and parental asthma, highlighting the complexity of this locus and childhood asthma.
Program/Contract:
ProgramContract
NIH Program Genetics of Asthma Sub-Phenotypes Impact Gene Regulation in Cell-Specific Patterns
NIH Program Viral and Host Determinants of Infant and Childhood Allergy and Asthma
NIH Program Project 1: Immune development and respiratory outcomes in children from diverse Wisconsin communities
NIH Program Environmental Health Data Science Core
NIH Program Gene Discovery in Asthma and Allergic Diseases
NIH Program ECHO II: Impact of environmental exposures on children's health and the co-morbidity of asthma and ADHD
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma consortium 3 (ICAC3)
NIH Program Childhood Asthma in Urban Settings Clinical Research Network - Leadership Center
NIH Program Vanderbilt Institute for Clinical and Translational Research (VICTR)
NIH Program Children's Respiratory and Environmental Workgroup (CREW)
NIH Program Children's Allergy and Asthma Data Repository (CADRE)
DOI: 10.21430/M3GWMGFRQ5
Subjects: 0
Study PI, contact:
NameOrganizationSite
Nathan Schoettler University of Chicago University of Chicago
Publications:
Genotypes in the 17q12-q21 asthma risk locus and early-life viral wheezing illnesses.. Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology Aug 2025. doi: 10.1111/pai.70165 [Pubmed: 40755347]
Resources:
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3683: COBRA and cGAMP Microparticles Provide Active and Stable Vaccine Platform
Status: New
Description: An acetalated dextran microparticle influenza vaccine encapsulating a broadly reactive COBRA hemagglutinin antigen and the STING agonist cGAMP was evaluated in mice, where it induced broadly neutralizing antibody responses, strong cellular immunity, and maintained immunogenicity after storage outside of cold-chain conditions, addressing key limitations of current influenza vaccines related to stability and variable efficacy.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M39AGJY7HV
Subjects: 0
Study PI, contact:
NameOrganizationSite
Kristy Ainslie University of North Carolina at Chapel Hill University of North Carolina at Chapel Hill, CIVR-HRP
Publications:
COBRA Hemagglutinin and cGAMP Loaded Ace-DEX Microparticles Provide a Broadly Active and Shelf-Stable Influenza Vaccine Platform.. Advanced therapeutics Feb 2024. doi: 10.1002/adtp.202300273 [Pubmed: 41788861]
Resources:
Advanced Therapeutics https://advanced.onlinelibrary.wiley.com/doi/10.1002/adtp.202300273]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3684: TRAC478 and saponin adjuvant enhance immune responses elicited by COBRA HA
Status: New
Description: COBRA H1 and H3 HA proteins were formulated with two adjuvant systems, TRAC478 emulsion and SAS. These COBRA HA antigen and adjuvant combinations were evaluated for their ability to elicit antigen-specific humoral and cellular immune responses against panels of historical H1N1 and H3N2 vaccine strains and compared to immune responses elicited by unadjuvanted HA subunit vaccines in influenza naive mice. The performance of these vaccine candidates were also evaluated in pre-immune ferrets.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3SQHGIDJJ
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ted Ross Cleveland Clinic Cleveland Clinic, Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
Amanda Lynch Cleveland Clinic Cleveland Clinic, Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
Jessica Medina Cleveland Clinic Cleveland Clinic, Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
Matthew Thomas Cleveland Clinic Cleveland Clinic, Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
Publications:
Synthetic TRAC478 emulsion and saponin based adjuvant systems enhance humoral and cellular immune responses elicited by computationally optimized H1 and H3 hemagglutinin subunit vaccines.. Vaccine Apr 2026. doi: 10.1016/j.vaccine.2026.128421 [Pubmed: 41812633]
Resources:
Vaccine link https://www.sciencedirect.com/science/article/abs/pii/S0264410X2600229X]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3686: Synthetic DNA co-immunization with vaccine-aligned common consensus nucleoprotein and hemagglutinin protects mice against lethal influenza infection with a single immunization
Status: New
Description: The authors engineered synthetic DNA vaccine candidates encoding vaccine-aligned common consensus (VACC) immunogens designed to represent the immune diversity of seasonal H1N1 and H3N2 virus NP proteins, and tested them in a high-dose challenge mouse model
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3THIZLR7B
Subjects: 0
Study PI, contact:
NameOrganizationSite
Frans Cuevas Icahn School of Medicine at Mount Sinai ISMM_SEM-CIVIC
Ami Patel The Wistar Institute WIST_SEM-CIVIC
Publications:
Synthetic DNA co-immunization with vaccine-aligned common consensus nucleoprotein and hemagglutinin protects mice against lethal influenza infection with a single immunization.. Frontiers in immunology None 2025. doi: 10.3389/fimmu.2025.1632121 [Pubmed: 41383614]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3687: Administration of Influenza Hemagglutinin in One Leg Elicits Similar Immune Responses as in Two Legs
Status: New
Description: Intramuscular vaccination of COBRA H1 and or H3 HA proteins in two distinct locations were compared to a single injection site in mice. B cell activation, antibody response and viral protection were evaluated to determine if increasing the distribution of antigen would increase immune responses.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3S4XS4FZ6
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ted Ross Other: Cleveland Clinic CLVC_CIVR-HRP
Publications:
Intramuscular administration of influenza hemagglutinin in one hind leg elicits similar protective immune responses as administration in two hind legs.. Virology Aug 2026. doi: 10.1016/j.virol.2026.110961 [Pubmed: 42202654]
Resources:
None None]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3689: GI-ARS Efficacy Study in Rhesus Macaques after Partial Body Irradiation (PBI/BM5) - Control Animals
Status: New
Description: Prior to irradiation, NHP were randomized to either a control (n = 15) or treated (n = 15) cohort. On Study Day (SD) 0, each NHP was sedated, restrained, and transported to the LINAC facility. They were then placed on the LINAC treatment table and positioned within the lighted radiation field in such a way that the whole body was contained within the field, with the exception of the tibiae, ankles, and feet (i.e., the field terminated at the inferior edge of the patella). After positioning, the NHPs were exposed to six (6) megavolt (MV) photons delivered at a dose rate of approximately 0.80 Gy/min, resulting in PBI/BM5 to a targeted dose of 12.0 Gy. Following irradiation, NHP were administered six (6) SC injections of either TA or CA (10 mM histidine buffer in water at 0.1 ml/kg) at 24 ± 2 hour intervals from the time of irradiation. All animals were monitored for complete blood count (CBC), plasma levels of blood urea nitrogen (BUN) and creatinine (Cr), body weight (BW), rectal body temperature (RBT), stool consistency, and clinical hydration status through the end of the in-life phase. Animals received medical management consisting of intravenous (IV) fluids, antibiotics, analgesics, antidiarrheals, antiemetics, blood transfusions, supplemental nutrition, and other support as required. rhesus macaques, Macaca mulatta, radiation, natural history, radiation sickness, gastrointestinal, hematology, histology, cytokines, RNCP Animals were euthanized according to a set of criteria based on clinical signs including activity level, weight loss, and responsiveness to antidiarrheal treatment, or between SD31 and SD35 if criteria were not met during the in-life phase. Survival was analyzed at 15 and 30 days postirradiation.
Program/Contract:
ProgramContract
Radiation/Nuclear Medical Countermeasure (MCM) Product Development Support Services Development of Medical Countermeasures to Mitigate or Treat the Gastrointestinal Acute Radiation Syndrome after a Nuclear or Radiation Incident
DOI: 10.21430/M3WHI3TIET
Subjects: 15
Study PI, contact:
NameOrganizationSite
Thomas MacVittie University of Maryland School of Medicine University of Maryland School of Medicine
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 225
Clinical Assessments:None
Release Notes:
NA

SDY3690: Optimizing delivery in subunit influenza vaccine using mixed microparticle degradation rates
Status: New
Description: Development of a multivalent influenza vaccine using acetalated dextran microparticles (Ace-DEX MPs) to deliver broadly reactive antigens and adjuvants. By tuning the degradation rates of these particles, researchers enhanced immune responses and reduced antigen dominance, showing promising protection against multiple flu strains in animal models.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3IZ6E0R6K
Subjects: 0
Study PI, contact:
NameOrganizationSite
Kristy Ainslie University of North Carolina UNCA_CIVR-HRP
Publications:
Optimizing delivery in a multivalent subunit influenza vaccine using mixed polymeric microparticle degradation rates.. Journal of controlled release : official journal of the Controlled Release Society Aug 2025. doi: 10.1016/j.jconrel.2025.113936 [Pubmed: 40482923]
Resources:
PubMed https://pubmed.ncbi.nlm.nih.gov/40482923/]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3692: SARS-CoV-2 omicron BA.2.87.1 exhibits higher susceptibility to serum neutralization than EG.5.1 and JN.1
Status: New
Description: Here, the authors characterized the antibody evasion, ACE2 receptor engagement, and viral infectivity of the highly mutated SARS-CoV-2 Omicron subvariant BA.2.87.1 in comparison to other Omicron subvariants.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3GFL7HC0D
Subjects: 40
Study PI, contact:
NameOrganizationSite
Aubree Gordon University of Michigan University of Michigan, Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
Publications:
SARS-CoV-2 omicron BA.2.87.1 exhibits higher susceptibility to serum neutralization than EG.5.1 and JN.1.. Emerging microbes & infections Dec 2024. doi: 10.1080/22221751.2024.2359004 [Pubmed: 38779718]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Virus Neutralization 320
Clinical Assessments:
Infection-History-245
Release Notes:
NA

SDY3693: Electroporation and LNP-mediated delivery of plasmid DNA-encoded H5N1 influenza virus hemagglutinin support protection against highly pathogenic avian influenza
Status: New
Description: The authors describe the generation of emergent H5 HPAI hemagglutinin (HA) DNA plasmids and characterize their immunogenicity and protective efficacy in lethal HPAI mouse challenge models
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M34J55Y3M7
Subjects: 0
Study PI, contact:
NameOrganizationSite
Frans Cuevas Icahn School of Medicine at Mount Sinai ISMM_SEM-CIVIC
Not Provided Not Provided Not Provided WIST_SEM-CIVIC
Publications:
Electroporation and LNP-mediated delivery of plasmid DNA-encoded H5N1 influenza virus hemagglutinin support protection against highly pathogenic avian influenza.. NPJ vaccines Nov 2025. doi: 10.1038/s41541-025-01316-5 [Pubmed: 41274914]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3694: Ferret model to mimic the sequential exposure of humans to historical H3N2 influenza viruses
Status: New
Description: The authors describe a ferret model to mimic the serial exposure of humans to antigenically different historical H3HA proteins
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3ILV6O73Y
Subjects: 0
Study PI, contact:
NameOrganizationSite
Yoshihiro Kawaoka University of Wisconsin-Madison School of Veterinary Medicine UWMV_SEM-CIVIC
Gabriele Neumann University of Wisconsin-Madison School of Veterinary Medicine UWMV_SEM-CIVIC
Publications:
Ferret model to mimic the sequential exposure of humans to historical H3N2 influenza viruses.. Vaccine Jan 2023. doi: 10.1016/j.vaccine.2022.12.005 [Pubmed: 36517323]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3695: Preclinical evaluation of DNA and mRNA-LNP H5N1 influenza vaccines
Status: New
Description: Mouse studies were conducted to assess antibody responses, viral challenge protection, and immune correlates following vaccination with DNA or mRNA-LNP constructs expressing full-length H5 hemagglutinin and neuraminidase derived from a contemporary clade 2.3.4.4b H5N1 virus. Vaccinated animals were evaluated for serological responses and survival following homologous viral challenge.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M30Z0ETB3H
Subjects: 0
Study PI, contact:
NameOrganizationSite
Nicholas Heaton Duke University DUKE_DCVC
Publications:
Development of DNA and mRNA-LNP vaccines against an H5N1 clade 2.3.4.4b influenza virus.. Journal of virology Aug 2025. doi: 10.1128/jvi.00795-25 [Pubmed: 40667976]
Resources:
Journal of Virology https://journals.asm.org/doi/10.1128/jvi.00795-25]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3696: Vaccination with antigenically complex hemagglutinin mixtures confers broad protection from influenza disease
Status: New
Description: Current seasonal influenza vaccines mainly elicit antibodies against highly variable epitopes in the HA head, requiring frequent updates due to antigenic drift. To broaden protection, we developed a complex mixture of recombinant HA antigens designed to shift immune responses toward more conserved regions of the protein. This approach enhanced antibody targeting of the HA stalk while maintaining or improving responses to the head domain. In animal models, these changes translated into better protection against both matched and mismatched viral strains compared to conventional vaccines. These findings suggest that antigenically diverse HA formulations can reduce head-domain immunodominance and represent a promising step toward universal influenza vaccine strategies.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M3Y7T8DDKG
Subjects: 257
Study PI, contact:
NameOrganizationSite
Nicholas Heaton Duke University Duke University, Duke CIVIC Vaccine Center (DCVC)
Publications:
Vaccination with antigenically complex hemagglutinin mixtures confers broad protection from influenza disease.. Science translational medicine May 2024. doi: 10.1126/scitranslmed.adj4685 [Pubmed: 38691617]
Resources:
science.org https://www.science.org/doi/10.1126/scitranslmed.adj4685]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 756
Hemagglutination Inhibition 144
Other 0
Q-PCR 48
Virus Neutralization 134
Virus Plaque Assay 45
Clinical Assessments:
Not Applicable
Release Notes:
NA

SDY3697: Comparison of IgK and IgL binding toward influenza virus hemagglutinin and SARS-CoV-2 Spike protein during primary viral infections
Status: New
Description: It has been identified in ferrets a light chain bias (IgL) in ferrets after influenza virus infection. To investigate if the light chain bias phenotype is consistent between species, serum immunoglobulin in humans, mice and pigs following virus infection were evaluated. The binding capacity to the immunodominant viral glycoprotein of the infecting virus of each IgL population was tested.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3DOG8R1BT
Subjects: 0
Study PI, contact:
NameOrganizationSite
Robert Richardson University of Georgia CLVC_CIVR-HRP
Giuseppe Sautto Other: Cleveland Clinic CLVC_CIVR-HRP
Amanda Lynch Other: Cleveland Clinic CLVC_CIVR-HRP
Ted Ross Other: Cleveland Clinic CLVC_CIVR-HRP
Matthew Thomas Other: Cleveland Clinic CLVC_CIVR-HRP
Publications:
Comparison of Igκ and Igλ binding toward influenza virus hemagglutinin and SARS-CoV-2 Spike protein during primary viral infections in humans, mice, and pigs.. Comparative immunology, microbiology and infectious diseases Jul 2026. doi: 10.1016/j.cimid.2026.102494 [Pubmed: 42361778]
Resources:
PubMed https://pubmed.ncbi.nlm.nih.gov/42361778/]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3699: mRNA-based influenza vaccine expands the B cell response breadth in humans
Status: New
Description: The authors assessed B cell responses in an observational study of cohorts of healthy young adults receiving a licensed, split-virion or investigative mRNA-based quadrivalent seasonal influenza virus vaccine over two consecutive seasons
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3EPB0IASJ
Subjects: 0
Study PI, contact:
NameOrganizationSite
Ali Ellebedy Washington University School of Medicine WUSM_SEM-CIVIC
Publications:
mRNA-based influenza vaccine expands the B cell response breadth in humans.. Nature immunology Jun 2026. doi: 10.1038/s41590-026-02569-5 [Pubmed: 42297975]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3700: Correlation of Binding and Neutralizing Antibodies to SARS-CoV-2 Omicron after BNT162b2 Vaccination
Status: New
Description: Adults vaccinated with BNT162b2 in 2020-2021 were stratified as infection-naive (n=29) or convalescent (n=27). Plasma was tested at baseline, 3 weeks after dose 1 (T1), and 1 month after dose 2 (T2) using MSD anti-spike IgG (reported in BAU/mL) and Abbott anti-RBD IgG, and Duke pseudovirus neutralization (ID50) against D614G, Beta, Delta, and Omicron (BA.1). Convalescent participants had higher binding IgG at all timepoints. Binding and neutralization correlated strongly overall; however, a larger fraction had undetectable Omicron neutralization even when binding IgG was positive.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Duke CIVIC Vaccine Center (DCVC)
DOI: 10.21430/M3YL9BWQ47
Subjects: 0
Study PI, contact:
NameOrganizationSite
David Montefiori Duke University DUKE_DCVC
Publications:
Correlation of Binding and Neutralizing Antibodies against SARS-CoV-2 Omicron Variant in Infection-Naïve and Convalescent BNT162b2 Recipients.. Vaccines Nov 2022. doi: 10.3390/vaccines10111904 [Pubmed: 36423000]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3701: Human monoclonal antibodies that target clade 2.3.4.4b H5N1 hemagglutinin
Status: New
Description: The authors generated a panel of anti-hemagglutinin (HA) human monoclonal antibodies (mAbs) against the H5 protein of clade 2.3.4.4b.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M37L56TQGR
Subjects: 1
Study PI, contact:
NameOrganizationSite
Florian Krammer Icahn School of Medicine at Mount Sinai ISMM_SEM-CIVIC
Andrew Ward The Scripps Research Institute TSRI_SEM-CIVIC
Publications:
Human monoclonal antibodies that target clade 2.3.4.4b H5N1 hemagglutinin.. Nature communications Dec 2025. doi: 10.1038/s41467-025-66829-y [Pubmed: 41390501]
Resources:
Not Applicable Not Applicable]
Assays:None
Clinical Assessments:None
Release Notes:
NA

SDY3702: T cell population correlates
Status: New
Description: Correlates of protection against symptomatic influenza virus infection
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3MQJHHU58
Subjects: 206
Study PI, contact:
NameOrganizationSite
Paul Thomas St. Jude Children's Research Hospital SJCH_CIVR-HRP
Robert Mettelman St. Jude Children's Research Hospital SJCH_CIVR-HRP
Publications:
Baseline innate and T cell populations are correlates of protection against symptomatic influenza virus infection independent of serology.. Nature immunology Sep 2023. doi: 10.1038/s41590-023-01590-2 [Pubmed: 37592015]
Resources:
None None]
Assays:None
Clinical Assessments:
PCRpositive
Release Notes:
NA

Updated Studies

SDY621: Registry for the Atopic Dermatitis Research Network (ADRN-02)
Status: Updated
Description: People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is known about the causes of AD or why people with AD are more prone to infections. The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant database for future studies.
Program/Contract:
ProgramContract
Atopic Dermatitis Research Network (ADRN) RFA-AI-14-033 Atopic Dermatitis Research Network (ADRN)
DOI: 10.21430/M3BWTEJ0L4
Subjects: 3611
Study PI, contact:
NameOrganizationSite
Lisa Beck University of Rochester Medical Center University of Rochester Medical Center
Kathleen Barnes Johns Hopkins Asthma and Allergy Center Johns Hopkins Asthma and Allergy Center
Publications:None
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01494142]
Assays:None
Clinical Assessments:None
Release Notes:
Study files added

SDY1190: Single-cell RNA-Seq analysis of MTB and DENV immune responses
Status: Updated
Description: Single-cell RNA-Seq assays were performed to precisely define the transcriptional profile of Dengue virus (DENV) and Mycobacterium tuberculosis (MTB) antigen specific CD4 T cells.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (La Jolla)
DOI: 10.21430/M3IFOL9MKV
Subjects: 16
Study PI, contact:
NameOrganizationSite
Pandurangan Vijayanand La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
Precursors of human CD4+ cytotoxic T lymphocytes identified by single-cell transcriptome analysis.. Science immunology Jan 2018. doi: 10.1126/sciimmunol.aan8664 [Pubmed: 29352091]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 7
RNA sequencing 16
Clinical Assessments:None
Release Notes:
Repository info updated

SDY1854: GI-ARS Efficacy study (180 Days) of Subcutaneous Filgrastim (PBI/BM5) in Rhesus Macaques after Partial Body Irradiation
Status: Updated
Description:

Rhesus macaques were exposed to partial-body irradiation with 5% bone marrow sparing to assess the effect of Neupogen (filgrastim, granulocyte colony stimulating factor [G-CSF]) to mitigate the associated myelosuppression when administered at 24, 72, or 120 hourse post irradiation. A secondary objective was to assess the effect of Neupogen on the mortality or morbidity of the hematopoietic (H)- acute radiation syndrome (ARS) and concomitant acute gastrointestinal radiation syndrome (GI-ARS), prolonged GI injury, acute and chronic kidney injury (AKI, CKI respectively) and delayed lung injury characteristic of delayed effects of acute radiation exposure (DEARE). NHP were exposed to 10 (N=20 males) or 11 Gy (N=28 males) with 6 MV LINAC-derived photons at approximately 0.80 Gy/min. All NHP received medical management. NHP were dosed daily with control article (5% dextrose in water) initiated on day 1 post-exposure or Neupogen (10 ug/kg) initiated on day 1, day 3, or day 5 until recovery (absolute neutrophil count [ANC] >= 1,000 cells/uL for 3 consecutive days). Keywords: rhesus macaques, Macaca mulatta, radiation, natural history, radiation sickness, hematopoietic, gastrointestinal, lung, hematology, metabolomics, histology, filgrastim, RNCP

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/M3ZE7NMJN9
Subjects: 48
Study PI, contact:
NameOrganizationSite
Thomas MacVittie University of Maryland, School of Medicine University of Maryland, School of Medicine
Publications:
Immune cell reconstitution after exposure to potentially lethal doses of radiation in the nonhuman primate.. Health physics Jan 2014. doi: 10.1097/HP.0b013e3182a2a9b2 [Pubmed: 24276552]
Linking the human response to unplanned radiation and treatment to the nonhuman primate response to controlled radiation and treatment.. Health physics Jan 2014. doi: 10.1097/HP.0b013e3182a12de0 [Pubmed: 24276556]
Increased Expression of Connective Tissue Growth Factor (CTGF) in Multiple Organs After Exposure of Non-Human Primates (NHP) to Lethal Doses of Radiation.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000343 [Pubmed: 26425899]
The Effect of Radiation Dose and Variation in NeupogenR Initiation Schedule on the Mitigation of Myelosuppression during the Concomitant GI-ARS and H-ARS in a Nonhuman Primate Model of High-dose Exposure with Marrow Sparing.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000350 [Pubmed: 26425903]
Citrulline as a Biomarker in the Non-human Primate Total- and Partial-body Irradiation Models: Correlation of Circulating Citrulline to Acute and Prolonged Gastrointestinal Injury.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000347 [Pubmed: 26425904]
Comparing the Hematopoetic Syndrome Time Course in the NHP Animal Model to Radiation Accident Cases From the Database Search.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000355 [Pubmed: 26425908]
Acute and Chronic Kidney Injury in a Non-Human Primate Model of Partial-Body Irradiation with Bone Marrow Sparing.. Radiation research Dec 2017. doi: 10.1667/RR24857.1 [Pubmed: 29035153]
Radiation Nephropathy in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing-Part 1: Acute and Chronic Kidney Injury and the Influence of Neupogen.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000960 [Pubmed: 30608245]
Radiation Nephropathy in a Nonhuman Primate Model of Partial-Body Irradiation With Minimal Bone Marrow Sparing-Part 2: Histopathology, Mediators, and Mechanisms.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000935 [Pubmed: 30624348]
The Time Course of Radiation-induced Lung Injury in a Nonhuman Primate Model of Partial-body Irradiation With Minimal Bone Marrow Sparing: Clinical and Radiographic Evidence and the Effect of Neupogen Administration.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000968 [Pubmed: 30624350]
The Gastrointestinal Subsyndrome of the Acute Radiation Syndrome in Rhesus Macaques: A Systematic Review of the Lethal Dose-response Relationship With and Without Medical Management.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000903 [Pubmed: 30624353]
Histopathological Features of the Development of Intestine and Mesenteric Lymph Node Injury in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000932 [Pubmed: 30624355]
Characterizing the Natural History of Acute Radiation Syndrome of the Gastrointestinal Tract: Combining High Mass and Spatial Resolution Using MALDI-FTICR-MSI.. Health physics Apr 2019. doi: 10.1097/HP.0000000000000948 [Pubmed: 30681424]
Lung and Heart Injury in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing: Histopathological Evidence of Lung and Heart Injury.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000936 [Pubmed: 30688698]
MALDI-MSI spatially maps N-glycan alterations to histologically distinct pulmonary pathologies following irradiation.. Scientific reports Jul 2020. doi: 10.1038/s41598-020-68508-y [Pubmed: 32665567]
Lack of Cellular Inflammation in a Non-human Primate Model of Radiation Nephropathy.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001329 [Pubmed: 32941291]
Acute Radiation-induced Lung Injury in the Non-human Primate: A Review and Comparison of Mortality and Co-morbidities Using Models of Partial-body Irradiation with Marginal Bone Marrow Sparing and Whole Thorax Lung Irradiation.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001346 [Pubmed: 33009295]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 5113
Clinical Assessments:None
Release Notes:
Experiment samples added

SDY1997: GI-ARS and H-ARS Dose-Response Relationship in Rhesus Macaques after Partial Body Irradiation
Status: Updated
Description:

The primary objective of this study is to determine the 60 day survival of rhesus macaques after irradiation to an approximate LD50/8-10 with tibial shielding and receiving medical management. These data were used to determine whether approximately 5% marrow sparing will allow spontaneous regeneration of the hematopoietic system subsequent to an otherwise supra-lethal dose of total-body irradiation and recovery from the acute GI radiation syndrome (GI-ARS). This model formed part of an non-human primate research platform used in subsequent studies to examine the effects of radiomitigating drugs on long-term survival of rhesus macaques after irradiation at the LD50/8-10 to induce GI syndrome with minimal marrow shielding and medical management. Animals were evaluated to Day 60 to evaluate the heme and GI syndromes and up to approximately Day 180 to evaluate the delayed effects of acute radiation exposure (DEARE). rhesus macaques, Macaca mulatta, radiation, natural history, radiation sickness, hematopoietic, gastrointestinal, lung, hematology, histology, metabolomics, RNCP

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/M3RNEV8J4M
Subjects: 58
Study PI, contact:
NameOrganizationSite
Thomas MacVittie University of Maryland School of Medicine University of Maryland School of Medicine
Publications:
Immune cell reconstitution after exposure to potentially lethal doses of radiation in the nonhuman primate.. Health physics Jan 2014. doi: 10.1097/HP.0b013e3182a2a9b2 [Pubmed: 24276552]
Linking the human response to unplanned radiation and treatment to the nonhuman primate response to controlled radiation and treatment.. Health physics Jan 2014. doi: 10.1097/HP.0b013e3182a12de0 [Pubmed: 24276556]
Increased Expression of Connective Tissue Growth Factor (CTGF) in Multiple Organs After Exposure of Non-Human Primates (NHP) to Lethal Doses of Radiation.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000343 [Pubmed: 26425899]
The Effect of Radiation Dose and Variation in NeupogenR Initiation Schedule on the Mitigation of Myelosuppression during the Concomitant GI-ARS and H-ARS in a Nonhuman Primate Model of High-dose Exposure with Marrow Sparing.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000350 [Pubmed: 26425903]
Citrulline as a Biomarker in the Non-human Primate Total- and Partial-body Irradiation Models: Correlation of Circulating Citrulline to Acute and Prolonged Gastrointestinal Injury.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000347 [Pubmed: 26425904]
Comparing the Hematopoetic Syndrome Time Course in the NHP Animal Model to Radiation Accident Cases From the Database Search.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000355 [Pubmed: 26425908]
Acute and Chronic Kidney Injury in a Non-Human Primate Model of Partial-Body Irradiation with Bone Marrow Sparing.. Radiation research Dec 2017. doi: 10.1667/RR24857.1 [Pubmed: 29035153]
Radiation Nephropathy in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing-Part 1: Acute and Chronic Kidney Injury and the Influence of Neupogen.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000960 [Pubmed: 30608245]
Radiation Nephropathy in a Nonhuman Primate Model of Partial-Body Irradiation With Minimal Bone Marrow Sparing-Part 2: Histopathology, Mediators, and Mechanisms.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000935 [Pubmed: 30624348]
The Time Course of Radiation-induced Lung Injury in a Nonhuman Primate Model of Partial-body Irradiation With Minimal Bone Marrow Sparing: Clinical and Radiographic Evidence and the Effect of Neupogen Administration.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000968 [Pubmed: 30624350]
The Gastrointestinal Subsyndrome of the Acute Radiation Syndrome in Rhesus Macaques: A Systematic Review of the Lethal Dose-response Relationship With and Without Medical Management.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000903 [Pubmed: 30624353]
Histopathological Features of the Development of Intestine and Mesenteric Lymph Node Injury in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000932 [Pubmed: 30624355]
Characterizing the Natural History of Acute Radiation Syndrome of the Gastrointestinal Tract: Combining High Mass and Spatial Resolution Using MALDI-FTICR-MSI.. Health physics Apr 2019. doi: 10.1097/HP.0000000000000948 [Pubmed: 30681424]
Lung and Heart Injury in a Nonhuman Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing: Histopathological Evidence of Lung and Heart Injury.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000936 [Pubmed: 30688698]
MALDI-MSI spatially maps N-glycan alterations to histologically distinct pulmonary pathologies following irradiation.. Scientific reports Jul 2020. doi: 10.1038/s41598-020-68508-y [Pubmed: 32665567]
Lack of Cellular Inflammation in a Non-human Primate Model of Radiation Nephropathy.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001329 [Pubmed: 32941291]
Acute Radiation-induced Lung Injury in the Non-human Primate: A Review and Comparison of Mortality and Co-morbidities Using Models of Partial-body Irradiation with Marginal Bone Marrow Sparing and Whole Thorax Lung Irradiation.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001346 [Pubmed: 33009295]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 5787
Clinical Assessments:None
Release Notes:
Experiment samples added

SDY2002: Natural History of the Gastrointestinal Acute Radiation Syndrome (GI-ARS) in Rhesus Macaques Following Partial Body Irradiation (2.5% Bone Marrow Sparing)
Status: Updated
Description:

A nonhuman primate model of acute, partial-body, high dose, irradiation (6 megavolt linear accelerator-derived photons delivered at 0.80 Gy minute-1) with 2.5% bone marrow sparing was used to assess the severity and natural history of the acute GI-ARS and associated, concurrent H-ARS and AKI consequent to 12 Gy irradiation. The primary endpoint was survival and secondary objectives focused on a) natural history components and morbidity of GI-ARS (d1-30 post exposure), b) acute kidney injury (AKI, d1-30+ post exposure), c) available database for lung and heart, d) organ-specific biomarkers: plasma- and tissue-based biomarkers for radiation dose and multi-organ injury. Assess the ability to predict DEARE (lung, heart, prolonged GI, kidney). All animals received subject-based medical management. rhesus macaques, Macaca mulatta, radiation, natural history, radiation sickness, hematopoietic, gastrointestinal, lung, hematology, histology, metabolomics, proteomics, lipidomics, bile acid, RNCP

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/M3TQH2ZN7E
Subjects: 42
Study PI, contact:
NameOrganizationSite
Thomas MacVittie University of Maryland School of Medicine University of Maryland School of Medicine
Publications:
Characterizing the Natural History of Acute Radiation Syndrome of the Gastrointestinal Tract: Combining High Mass and Spatial Resolution Using MALDI-FTICR-MSI.. Health physics Apr 2019. doi: 10.1097/HP.0000000000000948 [Pubmed: 30681424]
Evaluation of Plasma Biomarker Utility for the Gastrointestinal Acute Radiation Syndrome in Non-human Primates after Partial Body Irradiation with Minimal Bone Marrow Sparing through Correlation with Tissue and Histological Analyses.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001348 [Pubmed: 32947487]
Proteomics of Non-human Primate Plasma after Partial-body Radiation with Minimal Bone Marrow Sparing.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001350 [Pubmed: 32947488]
Proteomic Evaluation of the Natural History of the Acute Radiation Syndrome of the Gastrointestinal Tract in a Non-human Primate Model of Partial-body Irradiation with Minimal Bone Marrow Sparing Includes Dysregulation of the Retinoid Pathway.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001351 [Pubmed: 32947489]
Acute Proteomic Changes in Non-human Primate Kidney after Partial-body Radiation with Minimal Bone Marrow Sparing.. Health physics Oct 2021. doi: 10.1097/HP.0000000000001475 [Pubmed: 34546216]
Acute Proteomic Changes in Lung after Radiation: Toward Identifying Initiating Events of Delayed Effects of Acute Radiation Exposure in Non-human Primate after Partial Body Irradiation with Minimal Bone Marrow Sparing.. Health physics Oct 2021. doi: 10.1097/HP.0000000000001476 [Pubmed: 34546219]
Metabolomics of Multiorgan Radiation Injury in Non-human Primate Model Reveals System-wide Metabolic Perturbations.. Health physics Oct 2021. doi: 10.1097/HP.0000000000001472 [Pubmed: 34546220]
Effect of Radiation on the Essential Nutrient Homeostasis and Signaling of Retinoids in a Non-human Primate Model with Minimal Bone Marrow Sparing.. Health physics Oct 2021. doi: 10.1097/HP.0000000000001477 [Pubmed: 34546221]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 3279
Clinical Assessments:None
Release Notes:
Experiment samples added

SDY2058: GI-ARS Efficacy study (180 Days) of Subcutaneous Filgrastim or Pegfilgrastim in Rhesus Macaques after Partial Body Irradiation (PBI/BM2.5)
Status: Updated
Description:

Rhesus macaques were exposed to partial-body irradiation with 2.5% bone marrow sparing to assess the effect of Neupogen (filgrastim, granulocyte colony stimulating factor [G-CSF]) or Neulasta (pegfilgrastim, pegG-CSF) to mitigate the associated myelosuppression when administered at 24 or 72 hours post irradiation. A secondary objective was to assess the effect of Neupogen or Neulasta on the mortality or morbidity of the hematopoietic (H)- acute radiation syndrome (ARS) and concomitant acute gastrointestinal radiation syndrome (GI-ARS), prolonged GI injury, acute and chronic kidney injury (AKI, CKI respectively) and delayed lung injury characteristic of delayed effects of acute radiation exposure (DEARE). NHP were exposed to 10 Gy with 6 MV LINAC-derived photons at approximately 0.80 Gy/min. All NHP received medical management. NHP were dosed daily or weekly with control article (5% dextrose in water, or D5W), daily with Neupogen, or weekly with Neulasta. D5W was initiated on day 1 post-exposure. Neupogen (10 ug/kg) administration was initiated on days 1 or 3 post-exposure until recovery (absolute neutrophil count [ANC] >= 1,000 cells/uL for 3 consecutive days). Neulasta (300 ug/kg) administration was initiated on day 1 (days 1, 8, 15) or day 3 (days 3, 11, 17). Keywords: rhesus macaques, Macaca mulatta, radiation, natural history, radiation sickness, hematopoietic, gastrointestinal, lung, hematology, metabolomics, filgrastim, pegfilgrastim, RNCP

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/M3CXBS8APJ
Subjects: 44
Study PI, contact:
NameOrganizationSite
Thomas MacVittie University of Maryland School of Medicine University of Maryland School of Medicine
Publications:
The Evolving Mcart Multimodal Imaging Core: Establishing a Protocol for Computed Tomography and Echocardiography in the Rhesus Macaque to Perform Longitudinal Analysis of Radiation-Induced Organ Injury.. Health physics Nov 2015. doi: 10.1097/HP.0000000000000344 [Pubmed: 26425907]
Organ Doses Associated with Partial-Body Irradiation with 2.5% Bone Marrow Sparing of the Non-Human Primate: A Retrospective Study.. Radiation research Dec 2017. doi: 10.1667/RR14804.1 [Pubmed: 28985133]
Efficacy of Neulasta or Neupogen on H-ARS and GI-ARS Mortality and Hematopoietic Recovery in Nonhuman Primates After 10-Gy Irradiation With 2.5% Bone Marrow Sparing.. Health physics Mar 2019. doi: 10.1097/HP.0000000000000878 [Pubmed: 30281533]
Lack of Cellular Inflammation in a Non-human Primate Model of Radiation Nephropathy.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001329 [Pubmed: 32941291]
Evaluation of Plasma Biomarker Utility for the Gastrointestinal Acute Radiation Syndrome in Non-human Primates after Partial Body Irradiation with Minimal Bone Marrow Sparing through Correlation with Tissue and Histological Analyses.. Health physics Nov 2020. doi: 10.1097/HP.0000000000001348 [Pubmed: 32947487]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 3546
Clinical Assessments:None
Release Notes:
Experiment samples added

SDY2532: Germinal centre-driven maturation of B cell response to SARS-CoV-2 vaccination
Status: Updated
Description: The maturation dynamics of GC B cells and propagation of their progeny throughout the B cell diaspora have not been elucidated, therefore, here we show that anti-SARS-CoV-2 spike (S)-binding GC B cells were detectable in draining lymph nodes in those that were vaccinated against SARS-CoV-2. Using a combined approach of single-cell RNA sequencing of responding blood and lymph node B cells from eight participants and expression of the corresponding monoclonal antibodies, we tracked the evolution of 1540 S-specific B cell clones. This study documents the induction of affinity-matured BMPCs after two doses of SARS-CoV-2 mRNA vaccination in humans, providing a foundation for the sustained high efficacy observed with these vaccines.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3818VPQQM
Subjects: 43
Study PI, contact:
NameOrganizationSite
Ali Ellebedy Washington University School of Medicine Washington University School of Medicine, Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
Publications:
Germinal centre-driven maturation of B cell response to mRNA vaccination.. Nature Apr 2022. doi: 10.1038/s41586-022-04527-1 [Pubmed: 35168246]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 114
Other 15
RNA sequencing 56
Virus Neutralization 15
Clinical Assessments:
SARS-CoV-2_History
Release Notes:
Experiment added

SDY2809: Nasally delivered interferon lambda protects mice against SARS-CoV-2 infection
Status: Updated
Description: Here, we show that IFN-l protects against SARS-CoV-2 B.1.351 (Beta) and B.1.1.529 (Omicron) variants in three strains of conventional and human ACE2 transgenic mice
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3FGEA29GM
Subjects: 325
Study PI, contact:
NameOrganizationSite
Yoshihiro Kawaoka University of Wisconsin-Madison School of Veterinary Medicine University of Wisconsin-Madison, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
Nasally delivered interferon-l protects mice against infection by SARS-CoV-2 variants including Omicron.. Cell reports May 2022. doi: 10.1016/j.celrep.2022.110799 [Pubmed: 35523172]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
Q-PCR 885
RNA sequencing 12
Virus Plaque Assay 429
Clinical Assessments:
Not Applicable
Release Notes:
Experiment added

SDY3173: Sequential immunization with chimeric hemagglutinin del-NS1 attenuated influenza vaccines induces broad humoral and cellular immunity
Status: Updated
Description: Mice were intranasally administered cH8/1-del-NS1 followed by a cH11/1-del-NS1 heterologous booster, then challenged with seasonal H1N1 influenza virus and heterologous highly pathogenic avian H5N1.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Sinai-Emory Multi-Institutional CIVIC (SEM CIVIC)
DOI: 10.21430/M3QJKM5VTT
Subjects: 223
Study PI, contact:
NameOrganizationSite
Adolfo Garcia-Sastre Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai, Sinai-Emory Multi-Institutional CIVIC (SEM-CIVIC)
Publications:
Sequential immunization with chimeric hemagglutinin ?NS1 attenuated influenza vaccines induces broad humoral and cellular immunity. NPJ Vaccines Sep 2024. doi: doi: 10.1038/s41541-024-00952-7 [Pubmed: 39300090]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 1493
Other 45
Virus Plaque Assay 252
Clinical Assessments:
Not Applicable
Release Notes:
Experiment added

SDY3244: Influenza vaccination stimulates maturation of the human T follicular helper cell response
Status: Updated
Description: The differentiation and specificity of human CD4+ T follicular helper cells (TFH cells) after influenza vaccination have been poorly defined. Here we profiled blood and draining lymph node (LN) samples from human volunteers for over 2 years after two influenza vaccines were administered 1 year apart to define the evolution of the CD4+ TFH cell response. The first vaccination induced an increase in the frequency of circulating TFH (cTFH) and LN TFH cells at week 1 post-vaccination. This increase was transient for cTFH cells, whereas the LN TFH cells further expanded during week 2 and remained elevated in frequency for at least 3 months. We observed several distinct subsets of TFH cells in the LN, including pre-TFH cells, memory TFH cells, germinal center (GC) TFH cells and interleukin-10+ TFH cell subsets beginning at baseline and at all time points post-vaccination. The shift toward a GC TFH cell phenotype occurred with faster kinetics after the second vaccine compared to the first vaccine. We identified several influenza-specific TFH cell clonal lineages, including multiple responses targeting internal influenza virus proteins, and found that each TFH cell state was attainable within a clonal lineage. Thus, human TFH cells form a durable and dynamic multi-tissue network.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3YO7X2FEQ
Subjects: 5
Study PI, contact:
NameOrganizationSite
Paul Thomas St. Jude Children's Research Hospital St. Jude Children's Research Hospital, CIVR-HRP
Publications:
Influenza vaccination stimulates maturation of the human T follicular helper cell response. Nat Immunol August 2024. doi: 10.1038/s41590-024-01926-6 [Pubmed: 39164477]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 103
Clinical Assessments:None
Release Notes:
Experiment added

SDY3303: Influenza T cell response post-vaccination
Status: Updated
Description: To understand and identify changes in the profile of influenza strain-specific T cells from days 3 to 28 post immnunization with Fluzone. The strain-specific correlations of cellular immnunity to influenza with plasma analytes and serological immnunity were also analyzed. Quantification and phenotyping of influenza strain-specific T cells were performed, as well as plasma analyte profiling by Luminex.
Program/Contract:
ProgramContract
CIVICs Collaborative Influenza Vaccine Innovation Centers Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)
DOI: 10.21430/M3UNIMUM1W
Subjects: 37
Study PI, contact:
NameOrganizationSite
Elaine Reed University of California at Los Angeles University of California at Los Angeles, CIVR-HRP
Publications:
Influenza strain-specific T cell responses longitudinally post-vaccination with FluZone.. Vaccine Aug 2025. doi: 10.1016/j.vaccine.2025.127506 [Pubmed: 40680374]
Resources:
Not Applicable Not Applicable]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 351
Clinical Assessments:None
Release Notes:
Experiment samples added

SDY3504: Breast milk antibody Fc features linked to HIV transmission during breastfeeding
Status: Updated
Description: Breastfeeding shapes early immunity, but without antiretroviral therapy (ART), carries a risk of HIV transmission. The role of breast milk antibodies in this process remains unclear. Using systems serology, we profiled milk antibodies from transmitting and non-transmitting mothers in the Zambia Exclusive Breastfeeding Study. Transmission was linked to higher gp41-specific IgG1 and increased effector functions — including complement deposition (ADCD) and neutrophil phagocytosis (ADNP) — likely driven by elevated milk viral loads. In contrast, non-transmitting mothers showed p24-specific antibody responses inversely correlated with lower viral loads, suggesting better viral control. Fc glycosylation analysis revealed higher digalactosylated IgG in transmitting mothers, linked to enhanced neutrophil inflammatory cytokine release. IgG depletion experiments confirmed that IgG, not IgA, was the primary driver of neutrophil activation in transmitting mothers. Overall, these findings highlight distinct humoral immune signatures associated with HIV transmission risk or protection during breastfeeding and provide mechanistic insights relevant for maternal vaccine development and Fc-engineered broadly neutralizing antibody prevention strategies.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Maternal Omics to Maximize Immunity
DOI: 10.21430/M36HEJZR0A
Subjects: 100
Study PI, contact:
NameOrganizationSite
Grace Aldrovandi David Geffen School of Medicine at UCLA David Geffen School of Medicine at UCLA
Galit Alter Ragon Institute of MGH,MIT, and Harvard, Cambridge Ragon Institute of MGH,MIT, and Harvard, Cambridge
Boris Julg Ragon Institute of MGH,MIT, and Harvard, Cambridge Ragon Institute of MGH,MIT, and Harvard, Cambridge
Publications:
Breast milk antibody Fc signatures track with HIV transmission during breastfeeding in ART-naïve mothers. iScience November 2025. doi: None [Pubmed: 42006329]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Luminex xMAP 400
Clinical Assessments:None
Release Notes:
Corrected experiment records