DR68 DataRelease
Release Date: September 2026
New Studies: 28
Updated Studies: 20
New Studies
| SDY1848: Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients (CTOTC-11) | ||||||||||||||||||||||||||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||||||||||||||||||||||||||
| Description: | This will be a cohort study in which adolescent transplant recipients and their parents will be asked to answer a questionnaire battery and to have their charts reviewed by the research team. | |||||||||||||||||||||||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3S2B0LJH3 | |||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | 119 | |||||||||||||||||||||||||||||||||||||||||||||
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| Publications: | None | |||||||||||||||||||||||||||||||||||||||||||||
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| Assays: | None | |||||||||||||||||||||||||||||||||||||||||||||
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| SDY1862: Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (CTOTC-12) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Doctors give drugs called immunosuppressants (IS) to people who receive a liver transplant. IS must be taken every day to prevent the body from injuring the transplanted liver by a process called rejection. Liver transplant recipients usually have to take these drugs for the rest of their lives. These drugs have harmful side effects. Researchers are looking for ways to keep a transplanted liver working normally with as little IS medications as possible. Finding a way to lower and then stop these medications will allow the liver recipient to avoid unwanted side effects. Another area of research looks at how blood cells work to reject or accept an organ transplant. Studies show that some of the recipient's own cells, called T regulatory cells (Tregs), may play a part in accepting the transplanted liver and preventing rejection. A recipient's Tregs can be grown in the laboratory to increase their number. Exposing the recipient's Tregs to the liver donor's cells will stimulate the Tregs that recognize the liver donor to grow vigorously. Giving these "donor reactive" Tregs back to the transplant recipient through a vein (intravenously) might allow a liver transplant recipient to take lower doses of IS, or perhaps to stop them altogether, without rejecting the liver. The study team will collect information about the Treg infusion, liver tests and drug doses during IS withdrawal, and any problems that may arise in the study. Blood, liver tissue, and buccal (cheek) cells will be collected for research tests. | ||||||||||||
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| DOI: | 10.21430/M3JQKSL30Q | ||||||||||||
| Subjects: | 15 | ||||||||||||
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| Assays: | None | ||||||||||||
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| SDY1938: CLAD Phenotype Specific Risk Factors and Mechanisms (CTOT-20) | ||||||||||||||
| Status: | New | |||||||||||||
| Description: | This is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (QOL) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant accrual is within three years of study start-up. The total study duration is four years. Participants will be followed a minimum of 1 and a maximum of 4 years. | |||||||||||||
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| DOI: | 10.21430/M39EGA3V45 | |||||||||||||
| Subjects: | 884 | |||||||||||||
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| Assays: | None | |||||||||||||
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| SDY2225: Novel Mobile Device Application to Improve Adherence | ||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||
| Description: | This is a prospective, multi-center, randomized controlled study of subjects, children aged 11-17, during the first year after cardiac transplantation. Subjects will be assigned to receive the intervention (TPP) or the standard care (control arm). Subjects and parent/guardians assigned to the TPP intervention arm will use the application to perform daily health monitoring, to document medication administration, and to communicate with the research team (via automated text messaging) for a period up to 12 months post-transplantation. Subjects and parents/guardians assigned to the Control Group will receive standard clinical care per site procedures. | |||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3OXUQCLD8 | |||||||||||||||||||||
| Subjects: | 26 | |||||||||||||||||||||
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| Publications: | None | |||||||||||||||||||||
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| Assays: | None | |||||||||||||||||||||
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| SDY3066: Aberrant immune regulation and enrichment of stem-like CD8+ T cells in the pancreatic lymph node during type 1 diabetes | |||||||
| Status: | New | ||||||
| Description: | Our goal was to conduct multi-modal examination of immune cell populations in disease relevant tissue in order to understand how immune cell phenotype and function may be altered in T1D. Mass cytometry (n=12 control, n=10 T1D) and single cell RNA sequencing with T cell receptor sequencing (scRNAseq/TCRseq, n=7 control, n=9 T1D), performed using the 10x genomics platform, were conducted on pancreatic lymph node tissue from the network of pancreatic organ donors with diabetes (nPOD). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3OGEOFORM | ||||||
| Subjects: | 45 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
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| SDY3085: Humoral SARS-CoV-2 vaccine responses are durable in solid organ transplant recipients with and without HIV | ||||||||||
| Status: | New | |||||||||
| Description: | A prospective observational cohort single-center study was conducted of solid organ transplant recipients with and without HIV-1, who had received two doses of mRNA COVID-19 vaccine and were planning to receive additional doses. SARS-CoV-2 binding/neutralizing responses were measured at various timepoints post-vaccination. | |||||||||
| Program/Contract: |
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Publications: | None | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
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| SDY3487: Improved influenza vaccine responses after expression of multiple viral glycoproteins from a single mRNA | |||||||
| Status: | New | ||||||
| Description: | Using mRNA lipid nanoparticle (mRNA-LNP) technology, the authors engineered vaccines encoding influenza hemagglutinin (HA) and neuraminidase (NA), including a bicistronic NA-F2A-HA construct that co-expresses both antigens from a single mRNA. These vaccines were tested as single-antigen formulations, mixed formulations, strain-specific NA-F2A-HA vaccines, and a quadrivalent NA-F2A-HA mRNA-LNP mixture targeting H1N1, H3N2, and both influenza B lineages. In mice and ferrets, NA-F2A-HA mRNA-LNP vaccines elicited robust and functional antibody responses against both HA and NA, provided protection against lethal viral challenge, and outperformed or matched the licensed inactivated influenza vaccine Flulaval. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3642: Pre-vaccine Immune Profiling in Cancer Patients Identifies Correlates of COVID-19 Vaccine Responses | |||||||||||||
| Status: | New | ||||||||||||
| Description: | mRNA vaccines have been highly effective against SARS-CoV-2-related severe illness and are currently undergoing investigation as anti-cancer therapeutics. Our prior work has shown that patients undergoing cancer therapy have reduced immune responses to mRNA-based vaccines. Therefore, further investigation into immunologic responses in the setting of immune-altered hosts is warranted. In this study, we investigated pre-vaccination peripheral immune cell repertoire from a cohort of 66 patients with cancer on active treatment. Immune cell repertoire was characterized by mass cytometry to identify key immune subsets for COVID-19 vaccine response. Immunological populations were then assessed for their association with spike-specific antibody titers measured by ELISA and the breadth and depth of T-cell response to vaccine by TCR sequencing. Immune features significantly correlated with response were selected using an iterative bootstrapping model. We identified immunological features including abundance and functional state of T and B cells, expression of co-stimulatory and -inhibitory molecules, and presence of innate lymphoid cells, and myeloid-derived suppressor cells correlated with humoral and cellular responses. Our findings suggest that vaccine-induced immune responses could serve as biomarkers of immune fitness, in general and specifically for patients receiving anti-cancer mRNA vaccines, providing insights to tailor future therapeutic strategies for immune-altered patients. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3HXPSF52Q | ||||||||||||
| Subjects: | 0 | ||||||||||||
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| Assays: | None | ||||||||||||
| Clinical Assessments: | None | ||||||||||||
| Release Notes: |
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| SDY3698: Specificity, frequency and phenotype of citrullinated-specific T cells vary with disease activity in rheumatoid arthritis | |||||||
| Status: | New | ||||||
| Description: | In rheumatoid arthritis (RA), CD4+ T cells specific for citrullinated antigens (cit-specific) are key drivers of disease, but knowledge about epitopes and phenotypes remains limited. We characterized the frequency and phenotype of cit-specific CD4+ T cells in peripheral blood using HLA class II tetramers combined with computational analysis of phenotypic clusters to simultaneously detect peptides derived from five cit-antigens (aggrecan, vimentin, fibrinogen, cartilage intermediate layer protein and alpha-enolase) previously implicated in RA pathogenesis. In a cross-sectional cohort, cit-aggrecan, vimentin and fibrinogen-specific T cells were more frequent in RA than healthy participants, associated with active disease and had Th-1-like and stem-like lineages in RA. In a longitudinal cohort investigating response to therapy, the frequency of cit-aggrecan, vimentin and fibrinogen-specific CD4+ T cells was significantly higher at baseline and further elevated in responders. Furthermore, the frequency of cit-specific Th1-like cells in responders decreased over time. In contrast, the frequency of Th1-like cells in non-responders increased over time. Collectively these findings demonstrate that cit-specific CD4 T cells are expanded in RA and target a broad number of antigens across a breadth of phenotypes. Furthermore, the predominant antigen specificities associate with disease activity and exhibit dynamic changes in phenotype that reflect response to therapy. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3FHZA4KIC | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3713: IFN-gene signatures in B cells following influenza infection and vaccination | |||||||
| Status: | New | ||||||
| Description: | Analyse the transcriptional, phenotypic, and BCR profile of HA-specific single B cells in IAV and IBV infected hospitalized donors and inactivated influenza vaccinees using scRNA-seq. IAV and IBV infectivity of healthy PBMCs in vitro were compared to determine whether soluble factors in plasma of healthy or hospitalized participants affect the IAV or IBV infectivity of healthy PBMCs. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3714: The immune effects of cGAMP adjuvanted COBRA HA vaccines | |||||||||||
| Status: | New | ||||||||||
| Description: | To increase effectiveness of seasonal influenza vaccines, the COBRA HA antigens J4, Y1, and IAN5 were adjuvanted with cGAMP microparticles to enhance intracellular delivery. Sera samples were collected from naive mice vaccinated with H1, H3, and/or H5 COBRA HA proteins with cGAMP MPs. Further HAI assays, plaque assays, and ELISAs were performed to assess antibody responses to the vaccine following an influenza challenge. | ||||||||||
| Program/Contract: |
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| DOI: | None | ||||||||||
| Subjects: | 177 | ||||||||||
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| SDY3731: Structural and functional characterization of the antigenicity of influenza A virus hemagglutinin subtype H15 | |||||||||||||
| Status: | New | ||||||||||||
| Description: | The authors characterized a panel of mouse monoclonal antibodies (mAbs) raised against the A/wedge-tailed shearwater/Western Australia/2576/1979 ancestral strain, and a human mAb isolated from an H7N9 vaccinee. | ||||||||||||
| Program/Contract: |
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| DOI: | None | ||||||||||||
| Subjects: | 5 | ||||||||||||
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| Assays: | None | ||||||||||||
| Clinical Assessments: | None | ||||||||||||
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| SDY3742: Influenza B virus antibodies recognizing COBRA | |||||||
| Status: | New | ||||||
| Description: | Longitudinally in-depth profiled the antibody response of human subjects who received quadrivalent influenza vaccine (QIV). Following evaluation of their serological and memory B cell (Bmem) responses, the binding and functional activity of monoclonal antibodies (mAbs) derived from one of these individuals was defined, and mAbs endowed with a broad binding and functional profile and IBV COBRA HA, were identified. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3750: Functional Analysis of Complement Variants in a Genotyped iPSC Epithelial Cell Model System | |||||||
| Status: | New | ||||||
| Description: | CRISPR correction of the CFH Y402 locus | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3X5XM7A8O | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3751: Functional Analysis of Complement Variants in a Genotyped iPSC Epithelial Cell Model System | |||||||
| Status: | New | ||||||
| Description: | A complement expression in BB0108 cell-line exposed to cigarette smoke extract | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3057PT4H3 | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3752: Functional Analysis of Complement Variants in a Genotyped iPSC Epithelial Cell Model System | |||||||
| Status: | New | ||||||
| Description: | A complement expression in BB0152 cell-line exposed to cigarette smoke extract | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3072KX6YN | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3753: Beads-on-a-string (BOAS) immunogen | ||||||||||
| Status: | New | |||||||||
| Description: | Beads-on-a-string (BOAS) immunogens are recombinant protein immunogens that tandemly link hemagglutinin (HA) head domains end-to-end via short, flexible linkers. This plug-and-play multimerization strategy enables immunization with multiple, interchangeable HA variants with a single immunogen and circumvents multi-step assemblies such as those necessary for nanoparticle scaffolded immunogens. We have designed and characterized BOAS immunogens that included between three and eight unique HA subtypes spanning circulating and non-circulating A and B influenza strains and evaluated immunogenicity in the murine model. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
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| SDY3759: Combination of recombinant neuraminidase with inactivated split vaccines improves the breath of cross-reactivity and protection against influenza viruses in mice | ||||||||||
| Status: | New | |||||||||
| Description: | In this study, the authors analyze whether sequential immunization with group 2 chimeric HA inactivated split vaccines in combination with rN2 NA protein elicits superior immune responses in a mouse model. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
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| SDY3771: Influenza chimeric hemagglutinin structures in complex with broadly protective antibodies to the stem and trimer interface | ||||||||||
| Status: | New | |||||||||
| Description: | The authors report on crystal and negative-stain electron microscopy (nsEM) structures of two group 2 cHAs cH4/3 (H4 head and H3 stem) and cH15/3 (H15 head and H3 stem). | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
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| SDY3772: Breathing and Tilting: Mesoscale Simulations Illuminate Influenza Glycoprotein Vulnerabilities | |||||||
| Status: | New | ||||||
| Description: | The authors investigate the dynamics of influenza glycoproteins in a crowded protein environment through mesoscale all-atom molecular dynamics simulations. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3773: Isolation of human antibodies against influenza B neuraminidase and mechanisms of protection at the airway interface. | |||||||
| Status: | New | ||||||
| Description: | The authors describe the isolation of human monoclonal antibodies that recognized the IBV neuraminidase glycoprotein from a subject after seasonal vaccination. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3774: Administration of antigenically distinct influenza viral particle combinations as an influenza vaccine strategy | |||||||||||||
| Status: | New | ||||||||||||
| Description: | This study evaluated an experimental influenza vaccination strategy designed to broaden immune responses by combining antigenically distinct inactivated influenza A virus particles. Using the A/Hawaii/70/2019 H1N1 strain as a model, investigators generated a headless hemagglutinin influenza virus lacking the HA head domain while retaining the conserved HA stalk and neuraminidase and compared it with a conventional inactivated whole virus vaccine. Mice and ferrets were immunized intramuscularly with either the wild type inactivated virus, the headless HA virus, or a co-formulated combination of both vaccines using prime boost regimens. Immune responses were assessed by measuring HA head specific antibodies, HA stalk specific antibodies, neuraminidase inhibition activity, and overall antibody breadth. Protective efficacy was evaluated following homologous and heterologous viral challenge where applicable. The study demonstrated that the combination vaccine elicited a balanced immune response targeting both variable HA head epitopes and conserved HA stalk and NA antigens, overcoming immunodominance associated with HA head focused responses observed with conventional inactivated vaccines. These findings support the feasibility of combining antigenically distinct influenza virus particles to enhance immune breadth and inform development of improved seasonal or universal influenza vaccine strategies. | ||||||||||||
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| DOI: | None | ||||||||||||
| Subjects: | 56 | ||||||||||||
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| SDY3779: Human anti-N1 monoclonal antibodies elicited by pandemic H1N1 virus infection broadly inhibit HxN1 viruses in vitro and in vivo | ||||||||||||||||
| Status: | New | |||||||||||||||
| Description: | The authors describe human monoclonal antibodies from a patient with a pandemic H1N1 virus infection in 2009. | |||||||||||||||
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| DOI: | None | |||||||||||||||
| Subjects: | 0 | |||||||||||||||
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| Assays: | None | |||||||||||||||
| Clinical Assessments: | None | |||||||||||||||
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| SDY3780: A single mutation in dairy cow-associated H5N1 viruses increases receptor binding breadth | ||||||||||
| Status: | New | |||||||||
| Description: | The authors investigated whether recent H5N1 viruses are evolving their receptor binding specificities. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
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| SDY3781: Modification of H1N1 Influenza Luciferase Reporter Viruses Using StopGo Translation and/or Mouse-Adapted Mutations | |||||||
| Status: | New | ||||||
| Description: | This study created two influenza reporter viruses. The first, a fusion of PA and Nluc proteins, showed a growth defect. A second virus, using a "StopGo" translation mechanism to separate the proteins, replicated better in cells and sped up lab assays. However, the StopGo virus remained weakened in mice, requiring different mutations for virulence. The findings suggest StopGo is great for in vitro studies, while specific mouse-adapted mutations are still superior for in vivo work. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3782: Effect of Acid-Stabilizing Hemagglutinin Mutations on Immunogenicity and Heterologous Protection by H1N1 Influenza Virus mRNA-LNP Vaccines | |||||||
| Status: | New | ||||||
| Description: | The mRNA-LNP platform was used to assess HA antigens with the following acid-stabilizing mutations (E47K, K58I, R106K, and K153E) in the HA stalk, which all resulted in increased HA stability. E47K and R106K did not increase immunogenicity while K153E and K58I enhanced cell-surface HA expression. In vivo, K153E and K58I mRNA-LNP vaccines increased neutralizing antibody titers against homologous virus K153E and enabled greater protection than wild-type vaccine against lethal heterologous A/PR/8/34 challenge at low doses. K153E also provided greater expansion of antigen-specific antibody-secreting cells (ASCs) in the bone marrow, as well as cross-reactive T follicular helper (Tfh) cells in the spleen. For these vaccines, increased HA expression was a stronger correlate of mRNA-LNP enhancement than increased HA stability. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
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| SDY3783: Raised NK and T cell associated cytokines are related to the serological response to influenza vaccination | |||||||
| Status: | New | ||||||
| Description: | To understand the relationship of circulating analytes with total and strain-specific serological responses to influenza vaccination. Blood samples from a cohort of 100 participants were collected pre and post Fluzone vaccination in 2018 and 2019. Plasma chemokines and cytokines were quantified by 38-plex Luminex Assay, with ultra-sensitive quantification of additional analytes by Simoa assay. The seroprotection and serological response were determined by HAI titer change. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 100 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: | None | ||||||
| Release Notes: |
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| SDY3789: PREDICT Cytomegalovirus (CMV) - (CTOT-22) | |||||||||||||||||||||||||
| Status: | New | ||||||||||||||||||||||||
| Description: | Cytomegalovirus (CMV) is a common virus spread through infected body fluids. In people with a normal immune system it usually causes no symptoms and remains dormant for life. Lung transplant recipients take anti-rejection medications that suppress the immune system's ability to control CMV, so many receive antiviral prophylaxis (valganciclovir) early after transplant, during the period of highest infection risk. Some recipients develop active CMV infection after prophylaxis is stopped. This study prospectively assesses whether a blood test — an immune signature based on ex vivo measurement of T-cell CMV-specific immunity — can predict freedom from future CMV infection among CMV-seropositive (R+) lung transplant recipients receiving standard-duration valganciclovir prophylaxis. | ||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3U1XLLRKL | ||||||||||||||||||||||||
| Subjects: | 84 | ||||||||||||||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||||||||||||||
| Resources: |
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| Assays: | None | ||||||||||||||||||||||||
| Clinical Assessments: |
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| Release Notes: |
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Updated Studies
| SDY74: Systems Biology Approach to Analysis of 2010-11 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY301, SDY296) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | This study will measure the immune response to the influenza vaccine The long-term goal is to develop improved vaccines to infectious diseases such as influenza. Blood will be collected from patients at several visits before and after vaccination. The blood will be used in a series of immunological tests to measure the strength and breadth of immune response. These assays may include T cell and B cell activation assays, microarray testing, Epimax, Epigen, and flow cytometry. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3EJ72RVRG | ||||||||||||
| Subjects: | 12 | ||||||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Release Notes: |
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| SDY87: In-Depth Characterization of Immune Responses to Pneumovax Vaccination in Healthy Subjects | |||||||
| Status: | Updated | ||||||
| Description: | This study will measure the immune response to the Pneumovax vaccine The long-term goal is to develop improved vaccines to infectious diseases such as influenza. Blood will be collected from patients at several visits before and after vaccination. The blood will be used in a series of immunological tests to measure the strength and breadth of immune response. These assays may include T cell and B cell activation assays, microarray testing, Epimax, Epigen, and flow cytometry. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3AA0XR32D | ||||||
| Subjects: | 5 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
| Resources: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness SLVP015 | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M37NGTHMDS | ||||||||||||
| Subjects: | 91 | ||||||||||||
| Study PI, contact: |
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| SDY1481: Genetic and Environmental Factors in the Response to Influenza Vaccination 2014 | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | This is a phase IV study of 120 healthy 12-49 year old adolescents and adult volunteers who are given licensed seasonal influenza vaccine. There are no exclusions for gender, ethnicity or race. The volunteers will be enrolled into one of 3 groups: Group A: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+ 7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). Group B: Up to 40 healthy dizygotic (DZ) twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). Group C: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) or live, attenuated influenza vaccine quadrivalent (LAIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). This group was discontinued in 2016 due to ACIP recommendations against the use of LAIV but may be reopened in 2018 pending LAIV4 availability. Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3KVQXST4E | ||||||||||||
| Subjects: | 114 | ||||||||||||
| Study PI, contact: |
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| Release Notes: |
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| SDY1538: Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity | ||||||||||||||||||||||||||||
| Status: | Updated | |||||||||||||||||||||||||||
| Description: | Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use. To gain insight into how vaccines induce protection of the most vulnerable, our project employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV): (a) systems biology that uses technologies which comprehensively measure global changes in molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell composition of the blood and (b) use of human newborn blood components, collected prior to immunization, to model vaccine responses in vitro (outside the body). Characterizing vaccine-induced molecular patterns (signatures) that correspond to vaccine-mediated protection will accelerate development and optimization of vaccines against early life infections of major global health importance. | |||||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M35PWV2M56 | |||||||||||||||||||||||||||
| Subjects: | 727 | |||||||||||||||||||||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY1644: Urban Environmental Factors and Childhood Asthma (URECA) (ICAC-07) | ||||||||||||||||||||||||||||
| Status: | Updated | |||||||||||||||||||||||||||
| Description: | The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into three periods, as the subjects age from birth to 10 years old. Each age bracket will explore different objectives and endpoints. Study Objectives/Hypotheses: Subjects age 0 to 3 years old: Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3. Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6. Subjects age 4 to 7 years old: There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years. Subjects age 7 to 10 years old: There are unique combinations of environmental exposures (cockroach allergens, indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)], lack of microbial exposure), and family characteristics (stress, genetic factors related to innate immunity) that synergistically promote asthma onset, persistence, and morbidity in urban neighborhoods. These exposures and characteristics influence immune expression and lung development during critical periods of growth, resulting in specific asthma phenotypes. Subjects age 10 to 16 years old: To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence. | |||||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3H1YHLR5Z | |||||||||||||||||||||||||||
| Subjects: | 1218 | |||||||||||||||||||||||||||
| Study PI, contact: |
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| Publications: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY2195: Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) (ALE06) | |||||||
| Status: | Updated | ||||||
| Description: | One hundred twenty eligible subjects will be randomized in a 1:1 ratio to one of the two study treatment arms – continuing MMF treatment for 60 weeks or tapering off MMF within 12 weeks. All subjects will continue on their anti-malarials and may continue the use of their corticosteroids. Subject visits to assess endpoints will occur every 4 weeks from Day 0 through Week 24 and then at Weeks 32, 40, 48, and 60. As disease flares occur, subjects will be brought in for urgent, flare or endpoint visits to document symptoms, collect biological samples, and determine whether primary endpoint has been met. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3C5M9STYC | ||||||
| Subjects: | 123 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| Release Notes: |
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| SDY2367: Maternal immune response and placental antibody transfer by trimester of COVID-19 vaccination | ||||||||||
| Status: | Updated | |||||||||
| Description: | The availability of three COVID-19 vaccines in the United States provides an unprecedented opportunity to examine how vaccine platforms and timing of vaccination in pregnancy impact maternal and neonatal immunity. Here, we characterize the antibody profile after Ad26.COV2.S, mRNA-1273 or BNT162b2 vaccination in 158 pregnant individuals and evaluate transplacental antibody transfer by profiling maternal and umbilical cord blood in 175 maternal-neonatal dyads. These analyses reveal lower vaccine-induced functions and Fc receptor-binding after Ad26.COV2.S compared to mRNA vaccination and subtle advantages in titer and function with mRNA-1273 versus BN162b2. mRNA vaccines have higher titers and functions against SARS-CoV-2 variants of concern. First and third trimester vaccination results in enhanced maternal antibody-dependent NK-cell activation, cellular and neutrophil phagocytosis, and complement deposition relative to second trimester. Higher transplacental transfer ratios following first and second trimester vaccination may reflect placental compensation for waning maternal titers. These results provide novel insight into the impact of platform and trimester of vaccination on maternal humoral immune response and transplacental antibody transfer. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3GUZCJM05 | |||||||||
| Subjects: | 219 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY2584: Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity - Papua New Guinea (PNG) Validation cohort | |||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||
| Description: | Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use. To gain insight into how vaccines induce protection of the most vulnerable, our project employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV): (a) systems biology that uses technologies which comprehensively measure global changes in molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell composition of the blood and (b) use of human newborn blood components, collected prior to immunization, to model vaccine responses in vitro (outside the body). Characterizing vaccine-induced molecular patterns (signatures) that correspond to vaccine-mediated protection will accelerate development and optimization of vaccines against early life infections of major global health importance. | ||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/m3ec0qqknp | ||||||||||||||||||||||||
| Subjects: | 97 | ||||||||||||||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||||||||||||||
| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY2617: Placental transfer of maternal COVID-19 vaccine-induced antibodies in infants | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Completion of a COVID-19 vaccination series during pregnancy effectively reduces COVID-19 hospitalization among infants less than 6 months of age. The dynamics of transplacental transfer of maternal vaccine-induced antibodies and their persistence in infants at 2,6,9 and 12 months have implications for new vaccine development and optimal timing of vaccine administration in pregnancy. We evaluated anti-COVID antibody IgG subclass, Fc-receptor binding profile, and activity against wild-type Spike and RBD plus five variants of concern (VOCs) in 153 serum samples from 100 infants. Maternal IgG1 and IgG3 responses persisted in 2- and 6-month infants to a greater extent than the other IgG subclasses, with high persistence of antibodies binding placental neonatal Fc-receptor and FcγR3A. Lowest persistence was observed against the Omicron RBD-specific region. Maternal vaccine timing, placental Fc-receptor binding capabilities, antibody subclass, fetal sex, and VOC all impact the persistence of antibodies in infants through 12 months of age. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3B6120AR6 | ||||||||||||
| Subjects: | 195 | ||||||||||||
| Study PI, contact: |
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| Assays: |
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| SDY2618: Accelerated Weight Gain Among Infants With In Utero COVID-19 exposure | ||||||||||
| Status: | Updated | |||||||||
| Description: | We conducted a longitudinal cohort study leveraging a prospectively enrolled perinatal biorepository among 149 infants with in-utero COVID-19 exposure and 127 unexposed controls. Weight, length, and body mass index (BMI) were abstracted from health records at 0, 2, 6, and 12 months and standardized using World Health Organization growth charts. Analyses were adjusted for maternal age, ethnicity, parity, insurance, and BMI, as well as infant sex, birthdate, and breastfeeding. After our data collection and analysis, we evidenced that infants with in utero COVID-19 exposure exhibited lower birth weight and accelerated weight gain in the first year of life, which may be harbingers of downstream cardiometabolic pathology. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M33IM6KHA3 | |||||||||
| Subjects: | 276 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | |||||||||
| Clinical Assessments: |
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| Release Notes: |
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| SDY2696: Next Generation of Computationally Optimized Broadly Reactive HA Vaccines Elicited Cross-Reactive Immune Responses and Provided Protection Against H1N1 Virus Infection | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | In order to conquer the antigenic variability and improve influenza virus vaccine efficacy, our research group has developed computationally optimized broadly reactive antigens (COBRAs) in the form of recombinant hemagglutinins (rHAs) to elicit broader immune responses. However, previous COBRA H1N1 vaccines do not elicit immune responses that neutralize H1N1 virus strains in circulation during the recent years. In order to update our COBRA vaccine, two new candidate COBRA HA vaccines, Y2 and Y4, were generated using a new seasonal-based COBRA methodology derived from H1N1 isolates that circulated during 2013-2019. In this study, the effectiveness of COBRA Y2 and Y4 vaccines were evaluated in mice, and the elicited immune responses were compared to those generated by historical H1 COBRA HA and wild-type H1N1 HA vaccines. Mice vaccinated with the next generation COBRA HA vaccines effectively protected against morbidity and mortality after infection with H1N1 influenza viruses. The antibodies elicited by the COBRA HA vaccines were highly cross-reactive with influenza A (H1N1) pdm09-like viruses isolated from 2009 to 2021, especially with the most recent circulating viruses from 2019 to 2021. Furthermore, viral loads in lungs of mice vaccinated with Y2 and Y4 were dramatically reduced to low or undetectable levels, resulting in minimal lung injury compared to wild-type HA vaccines following H1N1 influenza virus infection. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M32NZ3B60O | ||||||||||||
| Subjects: | 160 | ||||||||||||
| Study PI, contact: |
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| Publications: |
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| SDY2917: Enhanced placental antibody transfer efficiency with longer interval between maternal respiratory syncytial virus vaccination and birth | |||||||||||||
| Status: | Updated | ||||||||||||
| 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: |
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| DOI: | 10.21430/M3E6U41NW0 | ||||||||||||
| Subjects: | 171 | ||||||||||||
| Study PI, contact: |
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| Release Notes: |
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| SDY3306: Protein networks are influenced by maternal BMI and differentiate preterm birth types | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | We conducted a study on a prospectively enrolled cohort of 100 pregnant individuals (30 spontaneous preterm birth, 30 medically-indicated preterm birth, 40 uncomplicated term deliveries) in which we profiled second-trimester plasma using a 7K SomaScan v4.1 aptamer-based proteomic assay to identify second-trimester maternal plasma proteomic signatures distinguishing spontaneous and medically-indicated preterm birth and to determine how body mass index modifies these profiles. Data revealed distinct proteomic profiles between spontaneous and medically indicated preterm birth, with obesity emerging as a key modifier of these molecular signatures. These findings offer new insight into obesity-related pathways involved in preterm birth. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3LI1BOAUL | ||||||||||||
| Subjects: | 100 | ||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||
| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| Release Notes: |
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| SDY3319: Chimeric hemagglutinin split vaccines elicit broadly cross-reactive antibodies and protection against group 2 influenza viruses in mice | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | The authors developed group 2 cHA vaccine candidates: cH15/3HK14N2HK14 and cH4/3HK14N2HK14. They have tested them as LAIVs, inactivated split vaccines, and combinations of these two platforms in the mouse model. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3BADY9PYZ | ||||||||||||
| Subjects: | 283 | ||||||||||||
| Study PI, contact: |
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| Release Notes: |
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| SDY3322: 5 HA mRNA Candidate Data Package | |||||||
| Status: | Updated | ||||||
| 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: |
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| DOI: | 10.21430/M35VOTL4RZ | ||||||
| Subjects: | 47 | ||||||
| Study PI, contact: |
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| Release Notes: |
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| SDY3435: Thin-film freeze-drying of an influenza virus mRNA vaccine with blebs | ||||||||||
| Status: | Updated | |||||||||
| Description: | Assess TFFD impact on particle properties, nanostructure (Cryo-EM, SAXS), RNA integrity (capillary electrophoresis), powder properties (PXRD, mDSC, SEM), and mouse immunogenicity (ELISA, HAI). | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3H7FVVQ4N | |||||||||
| Subjects: | 33 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: | None | |||||||||
| Release Notes: |
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| SDY3453: Maternal SARS-CoV-2 impacts fetal placental macrophage programs and placenta-derive | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | This cross-sectional study examined the transcriptional and functional impact of maternal SARS-CoV-2 infection on fetal Hofbauer cells (HBCs) and their potential utility as surrogates for fetal microglial programming. We enrolled 24 pregnant individuals delivering at Massachusetts General Hospital between March 2021 and June 2023: 10 with confirmed SARS-CoV-2 infection during pregnancy (median 12.2 weeks prior to delivery, unvaccinated) and 14 matched controls with no infection history. HBCs were isolated from term placentas using Percoll gradient separation and negative immunoselection (anti-EGFR, anti-CD10), yielding 31,719 high-quality cells for 10x Genomics single-cell RNA sequencing. We identified 8 fetal HBC subclusters (distinguished from maternal PAMMs using sex-chromosome markers DDX3Y/XIST in male placentas, N=10) with distinct baseline transcriptional programs including pro-inflammatory (HBC 3,4,7), stress response (HBC 0,1), tissue repair (HBC 2), and protein processing (HBC 6) phenotypes. Differential gene expression analysis revealed cluster-specific SARS-CoV-2 effects, with HBC 1 (723 DEGs) and HBC 5 (566 DEGs) most affected by number of DEGs, showing altered phagocytosis pathways and enrichment of neuroinflammation-associated signatures. Using direct cytokine reprogramming (IL-34, GM-CSF), we transdifferentiated HBCs into microglia-like cells (HBC-iMGs) expressing IBA1, TMEM119, P2RY12, PU.1, and CX3CR1. Functional phagocytosis assays using pHrodo Red-labeled synaptosomes from iPSC-derived neurons demonstrated significantly reduced phagocytic index in SARS-CoV-2-exposed HBC-iMGs (N=10) versus controls (N=9), with preserved cellular morphology (solidity, eccentricity). These findings establish proof-of-concept for using patient-specific HBC-iMGs as personalized models of fetal microglial programming following maternal immune activation. |
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| DOI: | 10.21430/M3KQHPU8ND | ||||||||||||
| Subjects: | 24 | ||||||||||||
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| SDY3472: Timing of de novo vaccination during pregnancy impacts maternal and newborn immunity | ||||||||||
| Status: | Updated | |||||||||
| Description: | This study examined how the timing of COVID-19 mRNA vaccination during pregnancy shapes maternal antibody responses and transplacental antibody transfer using comprehensive systems serology profilling in 263 pregnant individuals, including 96 maternal–neonatal dyads. Vaccine responses varied by gestational timing, with attenuated initial responses in third-trimester vaccinees but optimal antibody transfer when vaccination occurred in the late second to early third trimester, influenced further by fetal sex. Overall, the findings highlight gestational timing as a key determinant of effective maternal and neonatal immunity. | |||||||||
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| DOI: | 10.21430/M396B0IQPV | |||||||||
| Subjects: | 328 | |||||||||
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| Publications: | None | |||||||||
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| 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. | ||||||||||||
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| DOI: | 10.21430/M36HEJZR0A | ||||||||||||
| Subjects: | 100 | ||||||||||||
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