DR30 DataRelease
Release Date: 04/12/2019
| SDY616: Interferon Responses in Eczema Herpeticum (ADRN-01) | |||||||
| Status: | New | ||||||
| Description: | Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-g plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig)G2a. Recent studies have demonstrated that IFN-g generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-g induction leads to susceptibility to HSV infection in ADEH+ patients. | ||||||
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| DOI: | 10.21430/M34DAGM5W4 | ||||||
| Subjects: | 84 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1162: Meta-Analysis of Vaginal Microbiome Data Provides New Insights On Preterm Birth | |||||||
| Status: | New | ||||||
| Description: | Preterm birth (PTB) is defined as the birth of an infant before 37 weeks of gestational age. It is the leading cause of perinatal morbidity and mortality worldwide, with 15 million preterm births per year. Vaginal microbiome more specifically is known to change throughout pregnancy, and can even affect the fetus before delivery. This study presents the first meta-analysis of vaginal microbiome in preterm birth. This study integrated raw 16S ribosomal RNA vaginal microbiome data from three pregnancy related studies consisting of over 300 pregnant patients sampled longitudinally over the three trimesters. It was found that women who later have a preterm delivery, have a higher variance in their vaginal microbiome, with the largest, most significant difference between term and preterm patients being in samples collected during the first trimester. While several of the microbial genera have been reported previously, three of those nine microbial genera are newly reported here. New hypotheses emerging from such an integrative analysis can lead to novel diagnostics to identify women who are at higher risk for PTB and potentially inform new therapeutic interventions. | ||||||
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| DOI: | 10.21430/M3TRYB4WHX | ||||||
| Subjects: | 202 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1256: Small Sample- Big Data: The Gambia | |||||||||||
| Status: | New | ||||||||||
| Description: | To enable characterization of the molecular ontogeny in early life, we developed a robust experimental and analytical approach that applies system biology tools to peripheral blood samples from human newborns | ||||||||||
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| DOI: | 10.21430/M3IXMI1PCO | ||||||||||
| Subjects: | 30 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY1343: Toward more predictable birthdays | ||||||||||
| Status: | New | |||||||||
| Description: | Low-cost methods for monitoring fetal development could improve prenatal care, especially in low-resource settings. By measuring the levels of certain placental RNA transcripts in maternal blood, Ngo et al. developed two noninvasive blood tests that provide a window into the progression of individual pregnancies. In a small proof-of-concept study, the first blood test predicted fetal age and delivery date with an accuracy comparable to that of ultrasound. The second blood test, also examined in a small pilot study, discriminated women at risk of preterm delivery from those who delivered at full term. The next step will be to assess the reliability of the tests in large, blinded clinical trials. | |||||||||
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| DOI: | 10.21430/M3RP599G2M | |||||||||
| Subjects: | 69 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY1361: B cell sequencing data from individuals with kidney transplantation | ||||||||||
| Status: | New | |||||||||
| Description: | This data comes from peripheral blood from individuals that had a kidney transplantation. The study is a longitudinal study with data collected at time 0 (considered pre-transplant), 6 and 24 months after the transplant. They are classified in three clinical outcomes defined by pathology reads of serial allograft biopsies scored by Banff criteria and the chronic allograft damage index (CADI) score: Non progressors (NP; n=10) had low non incremental CADI score without acute rejection, progressors with no rejection (PNR; n=10) had incremental CADI score over 2 years without rejection, and progressors with rejection (PR; n=7) had incremental high CADI scores over 2 years with rejection episodes. This data reveal that the immune repertoire diversity of individuals that reject the organ is higher in comparison with those that did not reject the organ. Additionally, after 2 years of follow-up, patients who developed rejection show an overall reduction of B-celll diversity with persistence in and expansion of specific clones. | |||||||||
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| DOI: | 10.21430/M37EGAHB65 | |||||||||
| Subjects: | 27 | |||||||||
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| SDY1385: Flow Cytometry of T cells for TB Resistance Study | |||||||
| Status: | New | ||||||
| Description: | Intracellular Cytokine Staining data for human T cell responses to antigens specific to and not specific to Mycobacterium tuberculosis. COMPASS analysis shows that Ugandan TB ?resisters? exhibit IFNg-independent CD4 T cell responses, suggesting exposure to TB antigens despite negative test results. | ||||||
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| DOI: | 10.21430/M3SA04CC03 | ||||||
| Subjects: | 47 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1412: Small Sample- Big Data- Papua New Guinea Newborn Pilot Study | |||||||
| Status: | New | ||||||
| Description: | To enable characterization of the molecular ontogeny in early life, we developed a robust experimental and analytical approach that applies system biology tools to peripheral blood samples from human newborns | ||||||
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| DOI: | 10.21430/M3TEJV0F4I | ||||||
| Subjects: | 27 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1432: Clinical Islet Transplantation Consortium (CITC) | |||||||||||||||||||||||||||||||||||||
| Status: | New | ||||||||||||||||||||||||||||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. | ||||||||||||||||||||||||||||||||||||
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| DOI: | 10.21430/M34PPEBZA7 | ||||||||||||||||||||||||||||||||||||
| Subjects: | 0 | ||||||||||||||||||||||||||||||||||||
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| Assays: | None | ||||||||||||||||||||||||||||||||||||
| Clinical Assessments: | None | ||||||||||||||||||||||||||||||||||||
| SDY1437: Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation | |||||||
| Status: | New | ||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. CIT01 participants were randomized to study treatment including Low Molecular Weight Sulfated Dextran (LMW-DS) and study treatment without LMW-DS. Subjects in both arms received induction and maintenance immunosuppression consisting of ATG (basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus. CIT01 subjects randomized to the LMW-DS arm also received LMW-DS before and during islet transplant. | ||||||
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| DOI: | 10.21430/M3YZY4PXCS | ||||||
| Subjects: | 24 | ||||||
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| Assays: | None | ||||||
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| SDY1446: Comparing aerosol and intradermal boost regimes of candidate TB vaccine MVA85A. | |||||||
| Status: | New | ||||||
| Description: | There is an urgent need for an effective tuberculosis (TB) vaccine. Heterologous prime-boost regimens with recombinant viral vectors are effective at inducing induce high levels of potent cellular immunity. MVA85A is a candidate TB vaccine designed to boost BCG-induced immunity. This phase I experimental medicine clinical trial was designed to evaluate whether alternating aerosol and intradermal vaccination routes would boost the immune response cellular immunity to the Mycobacterium tuberculosis antigen 85A. | ||||||
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| DOI: | 10.21430/M3ER3DU6NW | ||||||
| Subjects: | 37 | ||||||
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| Publications: | None | ||||||
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| SDY56: Systems Biology of 2010 trivalent Influenza vaccine (TIV) in young and elderly (see companion study SDY61 2007, SDY270 2009, SDY119 2011) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Study Objective To identify innate signatures that correlate with the magnitude, quality and persistence of B cell responses after vaccination with TIV in the young versus the elderly. Study Design Single center, open label study in which adult healthy volunteers with no contraindications to immunization will be vaccinated with TIV. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30, D180 post vaccination to study innate and/or adaptive immunity markers. Even though influenza vaccination is considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Volunteers will be also asked to report local and systemic AEs developing the day of a blood draw. Additionally, only AEs considered related (unlikely, possibly, probably or definitely related) will be collected and reported in this study from Day 0 (vaccination) to Day 180. After Day 30 only related SAEs will be collected and reported. Study Duration 12 months (6 months accrual and 6 months follow-up period) |
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| DOI: | 10.21430/M3X9SKF8RQ | ||||||||||||
| Subjects: | 70 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY80: Cellular and molecular characterization of the immune response in healthy NIH employees at baseline and after immunization with the H1N1 or seasonal influenza vaccines | |||||||||||
| Status: | Updated | ||||||||||
| Description: | The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects (NIH employees) prior to vaccination and then at various time points after receiving the FDA-licensed seasonal and H1N1 influenza vaccine. These samples will be used to perform a comprehensive and detailed analysis of the immune system at baseline and in response to vaccination. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in a large number of healthy adults (NIH employees). This information may be useful in designing newer, more effective vaccines to prevent the spread of H1N1 influenza. | ||||||||||
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| DOI: | 10.21430/M3STAI2V6T | ||||||||||
| Subjects: | 64 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY888: Human Immune Signature of Dengue virus infection- Gene Expression of CD4 subsets | |||||||||
| Status: | Updated | ||||||||
| Description: | The human Immune Signature of Dengue virus infection was studied in two endemic areas. T cell responses were compared in infected patients and uninfected individuals also from Dengue endemic areas. | ||||||||
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| DOI: | 10.21430/M3C4L4WD2Z | ||||||||
| Subjects: | 92 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY984: Zoster vaccine in young and elderly | |||||||||||||||||
| Status: | Updated | ||||||||||||||||
| Description: | Study objective: To analyze the generic innate immune signatures that correlate with the magnitude of the adaptive immune responses (by gamma-interferon ELISPOT, responder-cell frequency (RCF) and flow cytometric studies) in young and elderly populations in order to identify the correlation signatures of the innate immune responses to Zoster vaccine.Study design: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected during a screening visit (between days D-56 to D-14) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 post vaccination to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported | ||||||||||||||||
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| DOI: | 10.21430/M36N1BYFT5 | ||||||||||||||||
| Subjects: | 77 | ||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||
| SDY997: AMP Lupus Network Project: Molecular Characterization of Lupus Nephritis and Correlation with Response to Therapy | ||||||||||
| Status: | Updated | |||||||||
| Description: | Phase I will be devoted to the study of at least 45 subjects with lupus nephritis and 25 controls with the intent of achieving the following goals: (i) to assess feasibility of obtaining a sufficient yield of high quality data based on current and refined AMP SOPs, (ii) to assess recruitment rates and the number of sites necessary to effectively recruit for Phase II, (iii) to ensure that the technologies developed in Phase 0 are working well, especially with regard to transport and scaling up to handle specimens from multiple sites; (iv) to demonstrate that the selected technologies can be used for the purpose of reliably differentiating lupus nephritis kidneys from kidney tissue without lupus nephritis, (v) where necessary, to further refine the technologies before embarking on a large-scale project; and most importantly (vi) to provide critical data upon which to make rational decisions about key elements of the Phase II study design (e.g., eligibility criteria, estimates of variation for power calculations, and site-specific capability regarding patient recruitment, specimen handling, etc.). | |||||||||
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| DOI: | 10.21430/M35FLWNXH1 | |||||||||
| Subjects: | 107 | |||||||||
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| Publications: | None | |||||||||
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| SDY998: AMP Rheumatoid Arthritis Phase 1 | ||||||||||||||||||||||||||||
| Status: | Updated | |||||||||||||||||||||||||||
| Description: | The primary goal for RA arthroplasty P1 studies are: To establish if molecular signatures and pathways identified using core AMP technologies differ between OA and RA in 20 RA surgical samples and 10 OA arthroplasty samples. | |||||||||||||||||||||||||||
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| DOI: | 10.21430/M3KXJHSP4T | |||||||||||||||||||||||||||
| Subjects: | 62 | |||||||||||||||||||||||||||
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| Publications: | None | |||||||||||||||||||||||||||
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| SDY1294: A Systems Vaccinology Approach Reveals Temporal Transcriptomic Changes of Immune Responses to the Yellow Fever 17D Vaccine. | |||||||
| Status: | Updated | ||||||
| Description: | In this study, we used a systems vaccinology approach to identify temporal changes in immune response signatures to the yellow fever (YF)-17D vaccine, with the aim of comprehensively characterizing immune responses associated with protective immunity. We conducted a cohort study in which 21 healthy subjects in China were administered one dose of the YF-17D vaccine; PBMCs were collected at 0 h and then at 4 h and days 1, 2, 3, 5, 7, 14, 28, 84, and 168 postvaccination, and analyzed by transcriptional profiling and immunological assays. At 4 h postvaccination, genes associated with innate cell differentiation and cytokine pathways were dramatically downregulated, whereas receptor genes were upregulated, compared with their baseline levels at 0 h. Immune response pathways were primarily upregulated on days 5 and 7, accompanied by the upregulation of the transcriptional factors JUP, STAT1, and EIF2AK2. We also observed robust activation of innate immunity within 2 d postvaccination and a durable adaptive response, as assessed by transcriptional profiling. Coexpression network analysis indicated that lysosome activity and lymphocyte proliferation were associated with dendritic cell (DC) and CD4+ T cell responses; FGL2, NFAM1, CCR1, and TNFSF13B were involved in these associations. Moreover, individuals who were baseline-seropositive for Abs against another flavivirus exhibited significantly impaired DC, NK cell, and T cell function in response to YF-17D vaccination. Overall, our findings indicate that YF-17D vaccination induces a prompt innate immune response and DC activation, a robust Ag-specific T cell response, and a persistent B cell/memory B cell response. | ||||||
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| DOI: | 10.21430/M3LT8WVHVH | ||||||
| Subjects: | 21 | ||||||
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