DR60 DataRelease
Release Date: January 2026
New Studies: 10
Updated Studies: 6
New Studies
| SDY1476: Analysis of cytokine profiles and cell counts in Dengue-exposed and Dengue-naive Zika cohorts over acute and convalescent timepoints. | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Analysis of cytokine profiles and cell counts in Dengue-exposed and Dengue-naive Zika cohorts over acute and convalescent timepoints. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M33A457GTQ | ||||||||||||
| Subjects: | 89 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
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| SDY2507: StopRA | ||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||
| Description: | Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disease that affects ~1% of the population, making it one of the most common chronic autoimmune diseases. The hallmark of RA is synovial inflammation (synovitis) that leads to joint destruction. RA primarily affects the joints, with small joints being the primary joints involved; however, multiple other systems including respiratory tract (e.g. interstitial lung disease), cardiovascular system (e.g. myocardial infarction) and bones (e.g. osteoporosis) can be affected. Recent studies have shown that there are markers in the blood called 'autoantibodies' that precede the onset of joint symptoms of RA. Antibodies are commonly made in the blood to fight infections. Sometimes, these antibodies attack one's own body. These are called autoantibodies. The autoantibody known as anti-CCP3 is specific for RA and may predict the development of RA in the future, especially if the level of anti-CCP3 is high. Hydroxychloroquine (HCQ) has been used successfully and safely in the treatment of malaria, lupus and RA. The objective of this study is to determine whether treatment with HCQ in individuals with elevations of anti-CCP3 without joint inflammation may help prevent the future onset of RA. This is a phase 2 multi-center, randomized, placebo-controlled, double-blind, clinical trial to evaluate the effectiveness and safety of intervention with a 12-month course of HCQ to prevent the future onset of clinically-apparent RA | |||||||||||||||||||||
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| DOI: | 10.21430/M3H5058PJ3 | |||||||||||||||||||||
| Subjects: | 252 | |||||||||||||||||||||
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| Publications: | None | |||||||||||||||||||||
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| Assays: | None | |||||||||||||||||||||
| Clinical Assessments: | None | |||||||||||||||||||||
| Release Notes: |
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| SDY3207: Inhibitory NK receptor expression associates with altered antimalarial function of gd T cells | |||||||||
| Status: | New | ||||||||
| Description: | Gamma delta (gd) T cells are important mediators of the immune response to childhood malaria infection. We explore phenotypic and functional differences of gd T cells in Ugandan children with high versus low malaria exposure, utilizing high-parameter spectral flow cytometry analysis of PBMCs. We observed significant differences in expression of inhibitory NK receptors - KIR2DL1, KIR2DL2/3, KIR3DL1, LILRB1, and NKG2A - on gd T cell subsets, with Vg9Vd2 T cells exhibiting a divergent mechanism of control compared to other subsets. We found that NKG2A and KIR3DL1 expression associated with potent Vg9Vd2 T cell responses to TCR- and FcR-mediated stimulation while KIR2DL1, KIR2DL2/3 and LILRB1 associated with reduced degranulation and cytokine production. These results identify a new role for inhibitory NK receptors expressed on gd T cells, exerting a finely tuned balance of activating and inhibitory signals to regulate their response to malaria-related antigens. | ||||||||
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| DOI: | 10.21430/M3QANIRXRI | ||||||||
| Subjects: | 75 | ||||||||
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| Publications: | None | ||||||||
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| Clinical Assessments: | None | ||||||||
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| SDY3274: Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST) (ITN524ST/CTOT-12) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Kidney transplantation remains the preferred treatment for end-stage renal disease, but long-term graft survival is challenged by the need for continuous immunosuppression, which carries substantial risks including infection and malignancy. While immunosuppressive regimens are highly effective at preventing acute rejection, their adverse effects underscore the need for strategies that can safely minimize drug exposure. Notably, a rare subset of kidney transplant recipients has been identified who maintain stable graft function without ongoing immunosuppression, exhibiting a distinctive molecular and cellular profile in peripheral blood. The ARTIST study is a multicenter, observational investigation enrolling adult kidney transplant recipients between one- and five-years post-transplant. The primary objective is to determine the prevalence and longitudinal stability of a previously characterized gene and B cell signature associated with operational tolerance. Participants are recruited across a spectrum of immunosuppressive regimens, including calcineurin inhibitors, mTOR inhibitors, and Campath induction, to ensure broad representation of clinical practice. At three annual study visits, demographic and clinical data are collected alongside peripheral blood and PBMC samples, enabling comprehensive molecular and immunophenotypic analyses. Gene expression profiling is performed using targeted RT-qPCR assays for key tolerance-associated genes (IGKV1D-13, IGKV4-1), complemented by multiparametric flow cytometry to quantify B cell subsets. Statistical modeling, including linear discriminant analysis, is applied to evaluate the discriminatory power of these biomarkers and their association with clinical variables. By benchmarking against established tolerant and immunosuppressed cohorts, the study aims to identify transplant recipients who, despite ongoing immunosuppression, exhibit the tolerance signature, potentially informing future strategies for personalized immunosuppression minimization. Importantly, ARTIST is strictly observational and does not alter participants’ clinical management. While direct medical benefit is not anticipated, the study provides critical insights into the biology of transplant tolerance and may ultimately facilitate safer, more effective immunosuppressive regimens for kidney transplant recipients. | ||||||||||||
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| DOI: | 10.21430/M3K94KYHFN | ||||||||||||
| Subjects: | 250 | ||||||||||||
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| Assays: | None | ||||||||||||
| Clinical Assessments: | None | ||||||||||||
| Release Notes: |
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| SDY3293: Characterizing immune cell subsets in lung adenocarcinoma | ||||||||||
| Status: | New | |||||||||
| Description: | This study sought to comprehensively characterize immune cell populations across peripheral blood, tumor, and non-tumoral adjacent lung tissue from patients with lung adenocarcinoma (LUAD) and to determine whether tumor-infiltrating immune profiles distinguish patient subgroups. We collected peripheral blood, tumor tissue, and adjacent lung tissue from 48 LUAD patients (stages I–IV; 28 stage I, 12 stage II, 7 stage III, 1 stage IV; equally male and female) who were treatment-naïve or at least six months from their last therapy. Using a 44-marker CyTOF panel, we profiled major T, B, NK, and myeloid subpopulations and initially identified 20 broad lineages, which were subsequently re-clustered using cell-type–specific markers into 66 distinct CD45+ subsets. On average, 2.12×10^5 live cells per sample were processed, with ~40% of events identified as CD45+. Paired comparisons revealed 57 subsets that differed between peripheral blood and tumor (30 enriched in tumor), 39 subsets that differed between tumor and adjacent tissue (21 enriched in tumor), and 12 subsets depleted in tumors relative to both tissues, including senescent CD8+ cells, two NK subsets, and four myeloid populations (classical monocytes, dysfunctional pDCs, cDCs, granulocyte precursors). Sixteen subsets, predominantly differentiated B cell populations—such as resident activated memory B cells, antigen-presenting B cells, atypical resident B cells, and multiple plasma cell types—were consistently elevated in tumors relative to both blood and adjacent tissue, indicating tumor infiltration. Principal component analysis of the 66 subsets showed clear separation of peripheral blood from lung tissues along PC1 (34.7% variance explained) and partial separation of tumor and adjacent tissue along PC2 (14.1%), with the greatest variability in tumor samples driven by these tumor-infiltrating subsets. Unsupervised k-means clustering of tumor immune profiles revealed four patient groups with distinct immune signatures. Group 1 tumors had markedly higher proportions of 10 B cell subsets, including resident activated memory, naïve, and antigen-presenting B cells, and also higher CD4+ CD69+ central memory T cells, with some tumors containing >40% CD19+ cells among CD45+ infiltrates. Group 2 tumors were enriched for CD8+ resident memory T cells, Group 3 for CD4+ activated effector (Th1-like) cells, and Group 4 for classical monocytes, early MDSCs, multiple NK subsets, naïve CD4+ and CD8+ T cells, and senescent CD8+ T cells, consistent with an immunologically inactive tumor microenvironment. Analysis of 15 B cell clusters showed that within-B cell composition also varied across groups: Group 1 exhibited the highest diversity of B cell subsets, Group 2 and Group 3 had reduced antigen-presenting and atypical resident B cells compared to Group 1, and Group 4 had lower resident activated memory and antigen-presenting B cells but higher IgD+ memory, activated naïve, and activated B cells. Together, these findings reveal that LUAD tumors have highly variable immune landscapes characterized by distinct mixtures of differentiated B cell and T cell populations that define patient subgroups beyond overall B cell abundance. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3TKGMMDTE | |||||||||
| Subjects: | 48 | |||||||||
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| Publications: | None | |||||||||
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| Clinical Assessments: | None | |||||||||
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| SDY3324: COVID-19 booster vaccine in autoimmune disease non-responders (ACV01) | ||||||||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||||||||
| Description: | ACV01 was a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring immunosuppressive (IS) medications. All study participants had negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. An adaptive design was employed such that cohorts and arms defined by additional vaccine doses and IS treatment plans could be added or modified based on emerging data from existing and new Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or approvals of COVID-19 vaccines. Adult Population Adult Stage 1: Stage 1 of this trial was planned to enroll up to 900 adult study participants (up to 60 participants per arm). The trial focused on adults with at least 1 of 5 autoimmune diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS), systemic sclerosis (SSc), and pemphigus. Participants were assigned to 1 of 3 cohorts based on their IS regimens: • Cohort A: Receipt of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) • Cohort B: Receipt of methotrexate (MTX) • Cohort C: Receipt of any B cell depletion therapy (BCDT) within the past 18 months. Treatment Arms: Participants in Cohorts A, B, and C were assigned to receive an additional dose of the same COVID-19 vaccine as their original vaccine series. The trial initially enrolled participants who were vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine. Update: Arms to receive an additional homologous vaccine dose after an initial Janssen COVID-19 Vaccine were closed to enrollment under v3.0 (04 January 2022) of the protocol after the Centers for Disease Control and Prevention (CDC) updated its recommendations to express a clinical preference for individuals to receive an mRNA COVID-19 vaccine over the Janssen COVID-19 vaccine. All Adult Stage 1 treatment arms were closed to enrollment on 15 August 2022. Participants in Cohorts A and B were randomized into two IS medication treatment plans as follows: • Participants continued to take their cohort-defining IS medications without alterations in schedule and dosing. • Participants withheld their cohort-defining IS medications before and after the additional homologous vaccine dose per protocol instructions. o If taking MMF/MPA, participants withheld their doses for 3 days before and 10 days after their vaccine dose. o If taking MTX, participants withheld their dose for at least 7 days before and at least 7 days after their vaccine dose, for a total of no more than 21 days. Adult Stage 2: Stage 2 of this trial was planned to include up to 960 adult study participants (up to 80 per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (at least 3 doses of mRNA vaccine(s) or 2 doses of the Janssen COVID-19 Vaccine). Participants would be eligible to receive a dose of an alternative COVID-19 vaccine. Participants may have received their previous COVID-19 vaccine prior to enrollment in the study (“newly recruited participant”), or they may have received their previous COVID-19 vaccine as a study participant and then (re-) entered into Stage 2 (“rollover participant”). Participants could also roll over into Stage 2 via two pathways: • Stage 1 participant rolling over to Stage 2 • Stage 2 participant rolling over to a different Stage 2 treatment arm Participants were allocated to 1 of 3 cohorts based on their IS regimens: • Cohort D: Receipt of MMF or MPA • Cohort E: Receipt of MTX • Cohort F: Receipt of any BCDT within the past 18 months. Treatment Arms: Participants in Cohorts D, E, and F received a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Originally, participants who previously received 3 total doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer-BioNTech COVID-19 Vaccine) received their choice of either the Janssen vector-based COVID-19 vaccine or the other mRNA COVID-19 vaccine, and participants who previously received 2 doses of the Janssen vector-based COVID-19 vaccine received the Moderna COVID-19 Vaccine. Update: Beginning with v4.0 (29 July 2022) of the protocol, participants who previously received 3 total doses of a single mRNA vaccine received their choice of an alternative mRNA COVID-19 vaccine or the Sanofi-GSK protein-based COVID-19 Vaccine. Participants who previously received 4 or more doses of a single mRNA vaccine or 3 or more doses of a mixture mRNA vaccines (Moderna COVID-19 Vaccine AND Pfizer-BioNTech COVID-19 Vaccine, in any order or combination) received the Sanofi-GSK protein-based COVID-19 vaccine. The trial no longer utilized the Janssen vector-based COVID-19 Vaccine. Beginning with v6.0 (11 November 2022) of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions. Participants in Cohorts D and E withheld their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions, as detailed above. Participants in Cohort F who were taking MMF, MPA, or MTX in addition to BCDTs withheld these medications before and after the alternative vaccine dose per protocol instructions. Pediatric Population Pediatric Stage 1: The pediatric portion of this trial was planned to enroll up to 800 participants (2-17 years of age) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after receiving an initial COVID-19 vaccine regimen (up to 80 participants per arm). Vaccines could be included in this protocol as they received EUA or approval by FDA for a given age group. Pediatric participants could have had at least 1 of 4 autoimmune diseases: pediatric SLE, juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), or pediatric-onset multiple sclerosis (POMS). Participants would have been assigned to 1 of 3 cohorts based on their IS regimens: • Cohort A: Receipt of MMF or MPA • Cohort B: Receipt of MTX • Cohort C: Receipt of any BCDT within the past 18 months. Treatment Arms: Participants in Cohorts A, B, and C would have been assigned to receive an additional dose of the same vaccine as their original vaccine series. Based on FDA EUA status, pediatric participants would have initially been eligible to receive the Pfizer-BioNTech COVID-19 Vaccine only. Update: Beginning with v6.0 (11 November 2022) of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions in the study design. Participants in Cohorts A and B would have been randomized into 2 IS medication treatment plans as follows): • Participants would have continued to take their cohort-defining IS medications without alterations in schedule and dosing. • Participants would have withheld their cohort-defining IS medications before and after the additional homologous vaccine dose per protocol instructions, as shown for Adult Stage 1. Pediatric Stage 2: Stage 2 of this trial was planned to include up to 480 pediatric study participants (up to 80 per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (an age-appropriate EUA-authorized or FDA-approved initial COVID-19 vaccine regimen plus 1 additional dose of the same vaccine). All participants (2-17 years of age) who previously received doses of the Pfizer-BioNTech COVID-19 Vaccine were eligible to receive an age-appropriate dose of the Moderna COVID-19 Vaccine. Participants 12 through 17 years of age who previously received doses of the Moderna COVID-19 vaccine were eligible to receive an age-appropriate dose of the Pfizer-BioNTech COVID 19 Vaccine. Participants were eligible to receive a dose of an alternative COVID-19 vaccine. Participants may have received their previous COVID-19 vaccine as a study participant and then entered into Stage 2 (“rollover participant”), or they may have received their previous COVID-19 vaccine prior to enrollment in the study (“newly recruited participant”). Participants were allocated to 1 of 3 cohorts based on their IS regimens: • Cohort D: Receipt of MMF or MPA • Cohort E: Receipt of MTX • Cohort F: Receipt of BCDT within the past 18 months. Treatment Arms: Participants in Cohorts D, E, and F received a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Participants who previously received age-appropriate doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer-BioNTech COVID-19 Vaccine, as noted above) received the other mRNA COVID-19 vaccine. Update: Beginning with v6.0 (11 November 2022) of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions. Participants in Cohorts D and E withheld their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions. Participants in Cohort F taking MMF, MPA, or MTX in addition to BCDTs withheld these medications before and after the alternative vaccine dose per protocol instructions. |
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| Program/Contract: |
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| DOI: | 10.21430/M35OC5U8Z7 | |||||||||||||||||||||||||||
| Subjects: | 148 | |||||||||||||||||||||||||||
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| Assays: | None | |||||||||||||||||||||||||||
| Clinical Assessments: | None | |||||||||||||||||||||||||||
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| SDY3359: CyTOF data of MC38 tumor-bearing mice treated with aPD-1-mEry | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Despite the success of immune checkpoint blockade therapy, its efficacy remains limited for many patients due to resistance. While the peripheral immune system is crucial in anti-tumor immunity, it can also be manipulated by cancer to facilitate tumor growth. Here, we developed an erythrocyte-anti-PD-1 antibody conjugate or αPD-1-Ery, where FDA-approved Pembrolizumab is covalently linked to erythrocyte membranes. Unlike conventional antibodies, αPD-1-Ery naturally accumulates in the spleen and remodels the local immune landscape by reducing immunosuppressive cells and expanding T cells in tumor-bearing mice. Treatment with αPD-1-Ery suppresses tumor growth in xenograft models resistant to anti-PD-1 therapy, dependent on spleen function. Furthermore, activated T cells by αPD-1-Ery reduce the splenic reservoir of myeloid suppressive cells and those within tumors, thereby enhancing anti-tumor immunity. In a clinical trial, autologous transfusion of αPD-1-Ery effectively reduces tumor growth in heavily treated cancer patients with resistance to anti-PD-1 therapies while maintaining safety. This result correlates with reductions in circulating myeloid suppressive cells and expansion of effector T cell subtypes. Our study suggests potential therapeutic strategies by targeting the peripheral immune system for overcoming immune checkpoint blockage resistance in cancer treatment. | ||||||||||||
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| DOI: | 10.21430/M3JUXBAJNT | ||||||||||||
| Subjects: | 3 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
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| SDY3368: Protection against influenza in young and elderly ferrets by adjuvanted influenza vaccine | |||||||
| Status: | New | ||||||
| Description: | To address these age-associated limitations in immune responsiveness, we evaluated Infectimune adjuvanted COBRA hemagglutinin (HA) recombinant vaccines in young (9 months) and elderly (50 to 71 months) ferrets with pre-existing immunity to historical influenza viruses A/Singapore/1986 (H1N1) and A/Panama/1999 (H3N2). Following vaccination, all ferrets were challenged with an A(H1N1) influenza virus A/Brisbane/2018 to determine the degree of protection conferred by the vaccines. Immune responses were analyzed by hemagglutination inhibition assay, influenza viral plaque assay, and enzyme-linked immunosorbent assay. There was an overall enhanced protective antibodies in adjuvant-vaccinated elderly ferrets. | ||||||
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| DOI: | 10.21430/M3U51ZJT1Q | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
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| SDY3400: A novel adjuvant system combining STING agonist-antigen conjugation with liposomal QS-21 exhibits potent synergistic Chlamydia vaccine immunogenicity | ||||||||||||||||||||||||||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||||||||||||||||||||||||||
| Description: | This study presents immunogenicity data from mice following intramuscular prime–boost vaccination with CPAF + ADU-S100, CPAF-STG1151, or CPAF-STG1151 + QS-21 formulated in liposomes. T-cell and antibody responses were assessed by ELISpot, intracellular cytokine staining, and ELISA. Serum cytokine levels were measured by ELISA following the prime immunization. In addition, in-vitro hemolysis, cytokine, and phagocytosis assays were performed to further characterize vaccine-induced responses. | |||||||||||||||||||||||||||||||||||||||||||||
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| DOI: | 10.21430/M3OOC528T7 | |||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | 95 | |||||||||||||||||||||||||||||||||||||||||||||
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| Publications: | None | |||||||||||||||||||||||||||||||||||||||||||||
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| Clinical Assessments: | None | |||||||||||||||||||||||||||||||||||||||||||||
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| SDY3406: Antibody titer elicited by six commercial influenza vaccines | ||||||||||
| Status: | New | |||||||||
| Description: | A three-season (2022-2023 to 2024-2025) study that included 1328 participants, ages 9 to 89 years, received one of six vaccine types (Fluzone standard dose (SD) or high dose (HD), Fluad, Flucelvax, Flublok, Flumist) and had serum samples tested for hemagglutination inhibition (HAI) activity against vaccine strains and historical circulating strains before vaccination and 28 days post vaccination. | |||||||||
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| DOI: | 10.21430/M3VO0G2RYX | |||||||||
| Subjects: | 0 | |||||||||
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| Publications: | None | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
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Updated Studies
| SDY620: Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study (ADRN-05) | |||||||
| Status: | Updated | ||||||
| Description: | This is a multi-site, randomized, open label, mechanistic study designed to compare the immune response in non-atopic and AD participants receiving a single dose of the 2012-2013 seasonal Fluzone Intradermal vaccine administered per label. A secondary objective is to compare the immune response of AD participants receiving intradermal influenza vaccination to the response of AD participants receiving intramuscular influenza vaccination. | ||||||
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| DOI: | 10.21430/M3UT5M218G | ||||||
| Subjects: | 368 | ||||||
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| Assays: | None | ||||||
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| SDY1027: The Role of Epigenetics in Inner City Asthma (ICAC-15) | |||||||||||||||||||
| Status: | Updated | ||||||||||||||||||
| Description: | The study is designed to determine the relation between methylation of CpG motifs and asthma in children residing in the inner city. | ||||||||||||||||||
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| DOI: | 10.21430/M3SXDBHQTS | ||||||||||||||||||
| Subjects: | 200 | ||||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||||
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| SDY1519: Eosinophilic Esophagitis Databank (CoFAR5) | ||||||||||||
| Status: | Updated | |||||||||||
| Description: | This is a multi-site, single visit registry in subjects aged 6 months to 65 years old, of any race, gender, or ethnicity with a biopsy confirmed EoE. Participants/parents/guardians will provide responses regarding the medical history, and will provide salivary and/or blood samples. The study team will have access to the participant's medical record to verify diagnosis information and medical history. | |||||||||||
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| DOI: | 10.21430/M36BWCCNH7 | |||||||||||
| Subjects: | 709 | |||||||||||
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| Assays: | None | |||||||||||
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| SDY1520: Peanut Epicutaneous Immunotherapy (CoFAR6) | ||||||||||||
| Status: | Updated | |||||||||||
| Description: | This is a multi-center, randomized, double-blind, placebo-controlled trial of DBV712 (Viaskin Peanut) in peanut-allergic subjects reacting to <1044 mg of peanut protein in an OFC. Subjects will be randomized to two doses of Viaskin Peanut patch or matched placebo (1:1:1) and then will undergo a 5044 mg of peanut protein OFC at week 52, designed to investigate the efficacy, safety and immunologic effects of Viaskin Peanut patch treatment for peanut allergy. Active Viaskin Peanut patch dosing will be with 100 ?g and 250 ?g patches applied every 24 hours and Viaskin placebo patch dosing will be with a placebo (no antigen) patch applied every 24 hrs. At 52 weeks, a 5044 mg of peanut protein OFC will occur. After the 52-week OFC the subject will be unblinded. In the unlikely event that an active subject on active treatment passes the week 52 OFC and has a peanut-specific IgE<2 kUA/L, he/she will discontinue dosing for up to 20 weeks. Sustained unresponsiveness (defined in Section 1.1) will be assessed with a 5044 mg of peanut protein OFCs, followed by an open feeding at 8 weeks, and if negative, again at 20 weeks. Those who pass the OFC after 20 weeks off treatment will be instructed to add peanut to their diet. Those that fail either of these OFCs will resume dosing as described in section 3. Subjects who fail the week 52 OFC, either active or placebo will dose with the 250 ?g dose from the time of unblinding (~ week 52) through week 130. After the 52-week OFC, placebo-treated subjects who do not demonstrate sustained unresponsiveness, will cross-over to active treatment at a dose of 250 ?g daily for a total of 30 months (130 weeks) of active therapy. At the end of study, all subjects will undergo a 5044 mg of peanut protein OFC on treatment; those who pass the OFC will have treatment discontinued and will have an OFC at 8 weeks and 20 weeks, to assess for sustained unresponsiveness off of therapy. Throughout the protocol, all subjects will remain on a peanut-free diet for the duration of active therapy and through any challenges after therapy is completed. | |||||||||||
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| DOI: | 10.21430/M397ZURMSI | |||||||||||
| Subjects: | 86 | |||||||||||
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| Assays: | None | |||||||||||
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| SDY1550: Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7) | ||||||||||
| Status: | Updated | |||||||||
| Description: | This is a multi-center, randomized, open label study to investigate sustained unresponsiveness induction and safety of Baked Egg vs. Egg OIT, for OFC documented egg allergy, in individuals who pass a 2 gm baked egg protein OFC. All eligible subjects will receive a double-blind placebo controlled baked egg OFC. Individuals who pass the baked egg OFC will then have a double-blind placebo controlled egg OFC. Those who react at a cumulative dose of <= 1444 mg of egg white protein will be randomized 1:1 to Baked Egg or Egg OIT. Approximately 40 of the first individuals who do not pass the initial baked egg food challenge will be assigned to Egg OIT and are the Egg OIT assignment group. Those who tolerate more than 1444 mg of egg white protein on the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1 year and a 2 year OFC. | |||||||||
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| DOI: | 10.21430/M3UFZVM91I | |||||||||
| Subjects: | 187 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
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| SDY2853: Broadly neutralizing antibodies target a haemagglutinin anchor epitope | ||||||||||||||||||||||
| Status: | Updated | |||||||||||||||||||||
| Description: | To investigate the specificities of HA-specific antibodies, we generated 358 mAbs from plasmablasts and HA+ memory B cells (MBCs) isolated from volunteers who were vaccinated against or naturally infected with seasonal influenza viruses or were participants in a phase I clinical trial of a chimeric HA (cHA) vaccine. | |||||||||||||||||||||
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| DOI: | 10.21430/M3XDGOCNIZ | |||||||||||||||||||||
| Subjects: | 0 | |||||||||||||||||||||
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| Clinical Assessments: | None | |||||||||||||||||||||
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