DR28 DataRelease
Release Date: 09/20/2018
| SDY823: Baminercept in Sjogren's Syndrome | |||||||
| Status: | New | ||||||
| Description: | This is a Phase 2, randomized, double-blind, placebo-controlled multi-center trial of baminercept versus placebo in patients with primary Sjogren's syndrome. The purpose of the study is to find out if the experimental study agent, baminercept, is safe and effective in treating patients with Sjogren's syndrome. The study will also attempt to understand the effect of the study agent on the underlying mechanisms (workings) of Sjogren's syndrome and the immune system. Concurrent therapy with hydroxychloroquine, prednisone, and/or cholinergic stimulants such as pilocarpine or cevimeline is permitted but not required. Seventy-two participants will be assigned by chance to 2 study groups: 48 participants will receive baminercept (the experimental study agent), 24 participants will receive a placebo. Baminercept or placebo will be given by injection under the skin once a week for 24 weeks (6 months). The first three injections of the study agent will be self-administered by the participant or a designated caregiver in the clinic under direct observation. Subsequent injections of study agent will be given at home. The study will consist of a screening phase, a treatment phase, and a post-treatment follow-up phase. During the screening phase, up to 2 visits are planned. Visits during the treatment phase are scheduled for Day 0 and Weeks 4, 8, 12, and 18. Additional safety post-injection visits are scheduled at Weeks 1 and 2. The primary endpoint visit is at Week 24 followed by 3 post-treatment follow-up visits at Weeks 30, 36, and 48. | ||||||
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| DOI: | 10.21430/M3RT6LAJH3 | ||||||
| Subjects: | 52 | ||||||
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| SDY951: Immune Development in Pediatric Transplantation | |||||||||
| Status: | New | ||||||||
| Description: | This is a multi-center, prospective, observational cohort study in pediatric renal transplant recipients. Target accrual in this study is 75 subjects over 2 years. Enrolled subjects will be categorized based on pre-enrollment CMV and EBV serology testing and be placed in the viral positive group, viral negative group, or split serology group. Subjects in the split serology group will not count towards study accrual target but will be included in analyses. CMV and EBV serology tests obtained for transplant evaluation will be collected retrospectively and used to categorize subjects. Subjects with previously negative serologies but later have positive serology results as indicated by testing on day of transplantation will be placed into the viral positive group. Subjects will have 6 study visits over 12 months as participants in this study. | ||||||||
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| DOI: | 10.21430/M3G5NIT3NL | ||||||||
| Subjects: | 108 | ||||||||
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| SDY1094: A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study | |||||||
| Status: | New | ||||||
| Description: | This study is a multicenter, non-randomized, retrospective study to collect long term (5 years posttransplant +/- 6 months) clinical outcome data on subjects previously enrolled in the CTOT-01 study. | ||||||
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| DOI: | 10.21430/M365BR5LW8 | ||||||
| Subjects: | 230 | ||||||
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| Assays: | None | ||||||
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| SDY1148: Genomic profiles of glioma progression | |||||||
| Status: | New | ||||||
| Description: | Gliomas are diverse neoplasms with multiple molecular subtypes. How tumor-initiating mutations relate to molecular subtypes as these tumors evolve during malignant progression remains unclear. We used genetically-engineered mouse models, histopathology, genetic lineage tracing, expression profiling, and copy number analyses to examine how genomic tumor diversity evolves during the course of malignant progression from low-to high-grade disease. | ||||||
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| DOI: | 10.21430/M31MOIU91D | ||||||
| Subjects: | 141 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1178: Islet Transplantation in Type 1 Diabetes (CIT-07) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | |||||||||||||||||||||||||||||||
| 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. Subjects in CIT07, a single arm Phase 3 license-enabling study, received induction and maintenance immunosuppression in an open-label fashion consisting of rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus and low-dose tacrolimus. | ||||||||||||||||||||||||||||||
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| DOI: | 10.21430/M3P7Q1ZRXJ | ||||||||||||||||||||||||||||||
| Subjects: | 48 | ||||||||||||||||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||||||||||||||||
| SDY1190: Single-cell RNA-Seq analysis of MTB and DENV immune responses | |||||||
| Status: | New | ||||||
| Description: | Single-cell RNA-Seq assays were performed to precisely define the transcriptional profile of Dengue virus (DENV) and Mycobacterium tuberculosis (MTB) antigen specific CD4 T cells. | ||||||
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| DOI: | 10.21430/M3IFOL9MKV | ||||||
| Subjects: | 16 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1231: Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation | |||||||
| Status: | New | ||||||
| Description: | Kidney transplantation is a treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients take immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. All anti-rejection medications have unwanted side effects. The purpose of this study is to evaluate the safety of slowly removing tacrolimus, a CNI. | ||||||
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| DOI: | 10.21430/M3ADHQNPY9 | ||||||
| Subjects: | 47 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1288: Chikungunya virus infection immunoprofiling in pediatric cohort | |||||||||
| Status: | New | ||||||||
| Description: | Serum/plasma, PAXgene and PBMC were collected from CHIKV-infected patients at acute (day 1-2 post symptom onset) and convalescent (day 15-17 post symptom onset) time points. RNA-seq (PAXgene samples), Luminex (serum/plasma samples) and CyTOF (PBMCs) was used to analyse the immune profile of CHIKV infection in a pediatric cohort from Nicaragua | ||||||||
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| DOI: | 10.21430/M3K4G9JI49 | ||||||||
| Subjects: | 43 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY1291: Merck Ad5/HIV induces broad innate immune activation that predicts CD8_ T-cell responses but is attenuated by preexisting Ad5 immunity. | |||||||
| Status: | New | ||||||
| Description: | This study will look for relationships among the immune responses induced by MRKAd5 HIV-1 gag/pol/nef vaccine. The study will also determine if the T cells that respond to different vaccine epitopes have correspondingly different functional profiles. The study will evaluate the safety and tolerability of the vaccine regimen as well. | ||||||
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| DOI: | 10.21430/M3BY9LGSBH | ||||||
| Subjects: | 10 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1300: RG-HRV16 Inoculum Dose Determination | |||||||
| Status: | New | ||||||
| Description: | The study will have a single-blind, 5+5 design for dose finding with dose de-escalation with a maximum of 4 groups of up to 10 healthy, HRV16 seronegative adult subjects inoculated with either placebo or a dose of 100, 500, 1000 or 10,000 TCD50 of RG-HRV16. Household or close contacts of research subjects will be invited to join in a surveillance portion of the protocol in order to obtain safety information on the transmission and severity of RG-HRV16 colds. | ||||||
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| DOI: | 10.21430/M3HFAE4ES9 | ||||||
| Subjects: | 36 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
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| SDY1325: B-cell responses to meningococcal vaccine. | |||||||
| Status: | New | ||||||
| Description: | Background: Neisseria meningitidis is a globally important cause of meningitis and septicaemia. Twelve capsular groups of meningococci are known, and quadrivalent vaccines against four of these (A, C, W and Y) are available as plain-polysaccharide and protein-polysaccharide conjugate vaccines. Here we apply contemporary methods to describe B-cell responses to meningococcal polysaccharide and conjugate vaccines. Methods: Twenty adults were randomly assigned to receive either a meningococcal plain-polysaccharide or conjugate vaccine; one month later all received the conjugate vaccine. Blood samples were taken pre-vaccination and 7, 21 and 28 days after vaccination; B-cell responses were assessed by ELISpot, serum bactericidal assay, flow cytometry and gene expression microarray. Results: Seven days after an initial dose of either vaccine, a gene expression signature characteristic of plasmablasts was detectable. The frequency of newly generated plasma cells (CXCR3+HLA-DR+) and the expression of transcripts derived from IGKC and IGHG2 correlated with immunogenicity. Notably, using an independent dataset, the expression of glucosamine (N-acetyl)-6-sulfatase was found to reproducibly correlate with the magnitude of immune response. Transcriptomic and flow cytometric data revealed depletion of switched memory B cells following plain-polysaccharide vaccine. | ||||||
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| DOI: | 10.21430/M3Q1ZBWOG2 | ||||||
| Subjects: | 20 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1364: Determining the Immune Response to MVA85A (tuberculosis vaccine candidate) | |||||||
| Status: | New | ||||||
| Description: | A better understanding of the relationships between vaccine, immunogenicity and protection from disease would greatly facilitate vaccine development. Modified vaccinia virus Ankara expressing antigen 85A (MVA85A) is a novel tuberculosis vaccine candidate designed to enhance responses induced by BCG. Antigen-specific interferon-_ (IFN-_) production is greatly enhanced by MVA85A, however the variability between healthy individuals is extensive. In this study we have sought to characterize the early changes in gene expression in humans following vaccination with MVA85A and relate these to long-term immunogenicity. Two days post-vaccination, MVA85A induces a strong interferon and inflammatory response. Separating volunteers into high and low responders on the basis of T cell responses to 85A peptides measured during the trial, an expansion of circulating CD4+ CD25+ Foxp3+ cells is seen in low but not high responders. Additionally, high levels of Toll-like Receptor (TLR) 1 on day of vaccination are associated with an increased response to antigen 85A. In a classification model, combined expression levels of TLR1, TICAM2 and CD14 on day of vaccination and CTLA4 and IL2R_ two days post-vaccination can classify high and low responders with over 80% accuracy. Furthermore, administering MVA85A in mice with anti-TLR2 antibodies may abrogate high responses, and neutralising antibodies to TLRs 1, 2 or 6 or HMGB1 decrease CXCL2 production during?in vitro?stimulation with MVA85A. HMGB1 is released into the supernatant following atimulation with MVA85A and we propose this signal may be the trigger activating the TLR pathway. This study suggests an important role for an endogenous ligand in innate sensing of MVA and demonstrates the importance of pattern recognition receptors and regulatory T cell responses in determining the magnitude of the antigen specific immune response to vaccination with MVA85A in humans. | ||||||
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| DOI: | 10.21430/M3NJTLGRT4 | ||||||
| Subjects: | 24 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1365: UC MAIT study | |||||||
| Status: | New | ||||||
| Description: | Establish whether MAIT cells participate in pathophysiology of UC | ||||||
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| DOI: | 10.21430/M3AV8VFYCB | ||||||
| Subjects: | 13 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
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| SDY1368: Systems Biology of Varicella Zoster Vaccination | |||||||
| Status: | New | ||||||
| Description: | Vaccination with attenuated live varicella zoster virus (VZV) can prevent zoster reactivation, but protection is incomplete especially in an older population. To decipher the molecular mechanisms underlying variable vaccine responses, T- and B-cell responses to VZV vaccination were examined in individuals of different ages including identical twin pairs. Contrary to the induction of VZV-specific antibodies, antigen-specific T cell responses were significantly influenced by inherited factors. Diminished generation of long-lived memory T cells in older individuals was mainly caused by increased T cell loss after the peak response while the expansion of antigen-specific T cells was not affected by age. Gene expression in activated CD4 T cells at the time of the peak response identified gene modules related to cell cycle regulation and DNA repair that correlated with the contraction phase of the T cell response and consequently the generation of long-lived memory cells. These data identify cell cycle regulatory mechanisms as targets to reduce T cell attrition in a vaccine response and to improve the generation of antigen-specific T cell memory, in particular in an older population. | ||||||
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| DOI: | 10.21430/M3P1TK6IXE | ||||||
| Subjects: | 18 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1370: Smallpox vaccination with LC16m8 vaccinia virus provides a gene expression profile similar to DryVax vaccination | |||||||
| Status: | New | ||||||
| Description: | Transcriptional analysis of global gene expression changes in naive subjects in response to smallpox vaccination with either DryVax or the replication-competent, attenuated LC16m8 vaccinia virus. | ||||||
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| DOI: | 10.21430/M3QHF445NF | ||||||
| Subjects: | 8 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1373: Next Generation Sequencing RNA Seq data from UKE Phase I rVSV ZEBOV vaccine clinical trial, from full blood samples on Days 0,1,3,7 | |||||||
| Status: | New | ||||||
| Description: | 10 adult participants of dose group 3x10^6 pfu, and 10 participants of dose group 20x10^6 pfu. Reads were aligned to the human reference assembly (GRCh38.p7) using STAR software (v2.4.2a; option '--quantMode GeneCounts'). Gene annotation was obtained from Ensembl (release 79, ensemble.org). VOOM+Limma analysis (R software, version 3.2.2) was used to assess differential gene expression at each post-vaccination day (d1, d3 and d7) against baseline (d0). Next, we intergreted gene expression data and antibody response using an sPLS algorithm, in order to down-select genes correlating with multivariate antibody responses at days 28, 54, 84,180. | ||||||
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| DOI: | 10.21430/M33F47FE9U | ||||||
| Subjects: | 18 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY270: Systems Biology of 2009 Influenza Vaccination in Humans (See companion studies SDY61 2007 / SDY269 2008 / SDY271 Role for CaMKIV in the Regulation of Antibody Responses to Influenza Vaccine) | |||||||||
| Status: | Updated | ||||||||
| Description: | Using a systems biology approach to study innate and adaptive responses to influenza vaccination in humans during the 2009-2010 influenza season. | ||||||||
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| DOI: | 10.21430/M3H9N1SFLO | ||||||||
| Subjects: | 30 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY314: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2008 (See companion studies SDY315 2012 / SDY312 2009 / SDY311 2010 / SDY112 2011) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||||||||
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| DOI: | 10.21430/M3WZ7XK2GG | ||||||||||||
| Subjects: | 92 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY820: Human Immune Signature of Mycobacterium Tuberculosis infection. (See SDY1324 for sorted cell gene expression data) | |||||||||
| Status: | Updated | ||||||||
| Description: | The human immune signature of latent Mycobacterium tuberculosis infected patients as well as BCG vaccinated and BCG non-vaccinated individuals was studied by flow cytometry | ||||||||
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| DOI: | 10.21430/M3D02NOSVH | ||||||||
| Subjects: | 60 | ||||||||
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| Clinical Assessments: | None | ||||||||