DR28 DataRelease

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.
Program/Contract:
ProgramContract
Autoimmunity Centers of Excellence (ACE) Baminercept in Sjogren's Syndrome (ASJ02)
DOI: 10.21430/M3RT6LAJH3
Subjects: 52
Study PI, contact:
NameOrganizationSite
Publications:
Clinical Efficacy and Safety of Baminercept, a Lymphotoxin ? Receptor Fusion Protein, in Primary Sjogren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.. Arthritis Rheumatol. Sep 2018. doi: 10.1002/art.40513. Epub 2018 Jul 18. [Pubmed: 29604186]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01552681]
Assays:
Assay TypeNumber of Exp. Samples
Luminex xMAP 191
Transcription profiling assay 96
Clinical Assessments:
EULAR Sjogrens Syndrome Disease Activity Index
Salivary Flow
Schirmer I Test
SF-36
Sjogrens Syndrome Symptom Survey
Visual Analog Scale Assessment
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.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation in Children (CTOT-C) DEVELOPMENT OF TRANSPLANT STRATEGIES UNIQUELY RESPONSIVE TO THE NEEDS OF CHILDREN (CTOTC-02)
DOI: 10.21430/M3G5NIT3NL
Subjects: 108
Study PI, contact:
NameOrganizationSite
Allan Kirk Emory University Emory University
Publications:
Optimization for peptide sample preparation for urine peptidomics.. Clin Proteomics. Feb 2014. doi: 10.1186/1559-0275-11-7. [Pubmed: 24568099]
Relationship Among Viremia/Viral Infection, Alloimmunity, and Nutritional Parameters in the First Year After Pediatric Kidney Transplantation.. Am J Transplant. Jun 2017. doi: 10.1111/ajt.14169 [Pubmed: 27989013]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00951353]
Assays:
Assay TypeNumber of Exp. Samples
Other 424
Protein microarray 40
Transcription profiling by array 79
Clinical Assessments:
Adolescent Medication Barriers Scale
Biopsy
BMQ Administration
BMQ Scoring
Parent Medication Barriers Scale
Rejection
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.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) NONINVASIVE MARKERS AND TRANSPLANT OUTCOME IN HUMANS (CTOT-01, CTOT-05)
DOI: 10.21430/M365BR5LW8
Subjects: 230
Study PI, contact:
NameOrganizationSite
Peter Heeger Mount Sinai School of Medicine, Ricanati Miller Transplant Institute Mount Sinai School of Medicine,
Publications:
Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17.. Transplantation. Apr 2018. doi: 10.1097/TP.0000000000002026. [Pubmed: 29189482]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT01974999]
Assays:None
Clinical Assessments:
Death
Graft Loss
Height
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.
Program/Contract:
ProgramContract
Enhance Applicability of Mouse Models for Translational Research (Oncology Model, OMF) Credentialing Murine Models For Glioblastoma Preclinical Drug Development (Oncology Model, OMF)
DOI: 10.21430/M31MOIU91D
Subjects: 141
Study PI, contact:
NameOrganizationSite
Ryan Miller University of North Carolina School of Medicine
Publications:
Genomic profiles of low-grade murine gliomas evolve during progression to glioblastoma.. Neuro Oncol. Sep 2017. doi: 10.1093/neuonc/nox050. [Pubmed: 28398584]
Resources:
PRJNA213446 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA213446]
PRJNA213443 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA213443]
PRJNA213444 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA213444]
PRJNA213445 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA213445]
PRJNA170315 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA170315]
PRJNA170316 https://www.ncbi.nlm.nih.gov/bioproject/PRJNA170316]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 51
Transcription profiling by array 160
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.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium B-LYMPHOCYTE IMMUNOTHERAPY IN ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium STRATEGIES TO IMPROVE LONG TERM ISLET GRAFT SURVIVAL
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANT FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium CLINICAL REFINEMENT OF ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION AT NORTHWESTERN
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION: DATA COORDINATING CENTER
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION: CLINICAL CENTERS
DOI: 10.21430/M3P7Q1ZRXJ
Subjects: 48
Study PI, contact:
NameOrganizationSite
Bernhard Hering University of Minnesota University of Minnesota
Xunrong Luo Northwestern University Northwestern University
Olle Korsgren Uppsala Univ. Hospital Uppsala Univ. Hospital
Nicole Turgeon Emory University Emory University
Ali Naji University of Pennsylvania University of Pennsylvania
Andrew Posselt University of California, San Francisco University of California, San Francisco
Camillo Ricordi University of Miami University of Miami
James Shapiro University of Alberta University of Alberta
Dixon Kaufman University of Wisconsin University of Wisconsin
Publications:
Improvement in beta-cell secretory capacity after human islet transplantation according to the CIT07 protocol.. Diabetes. Aug 2013. doi: 10.2337/db12-1802. Epub 2013 Apr 29. [Pubmed: 23630300]
Insulin sensitivity index in type 1 diabetes and following human islet transplantation: comparison of the minimal model to euglycemic clamp measures.. Am J Physiol Endocrinol Metab. May 2014. doi: 10.1152/ajpendo.00667.2013. Epub 2014 Apr 1. [Pubmed: 24691031]
Restoration of Glucose Counterregulation by Islet Transplantation in Long-standing Type 1 Diabetes.. Diabetes. May 2015. doi: 10.2337/db14-1620. Epub 2014 Dec 18. [Pubmed: 25524910]
Consistency of quantitative scores of hypoglycemia severity and glycemic lability and comparison with continuous glucose monitoring system measures in long-standing type 1 diabetes.. Diabetes Technol Ther. Apr 2015. doi: 10.1089/dia.2014.0289. Epub 2015 Jan 28. [Pubmed: 25629445]
Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. Jul 2016. doi: 10.2337/dc15-1988. Epub 2016 Apr 18. [Pubmed: 27208344]
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.. Diabetes. Nov 2016. doi: b 2016 Jul 27. [Pubmed: 27465220]
Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes.. J Clin Endocrinol Metab. Nov 2016. doi: b 2016 Aug 29. [Pubmed: 27571180]
Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue.. J Clin Invest. Apr 2017. doi: 10.1172/JCI87993. Epub 2017 Mar 20. [Pubmed: 28319051]
Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. May 2018. doi: 10.2337/dc17-1779. Epub 2018 Mar 21. [Pubmed: 29563196]
Resources:
CIT-07 ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00434811]
CIT-08 ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01369082]
NIDDK Repository https://repository.niddk.nih.gov/studies/cit-07/]
Clinical Islet Transplantation Consortium https://www.citisletstudy.org/]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 219
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.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (HIPC2)
DOI: 10.21430/M3IFOL9MKV
Subjects: 16
Study PI, contact:
NameOrganizationSite
Pandurangan Vijayanand La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 7
RNA sequencing 16
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.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) NONINVASIVE MARKERS AND TRANSPLANT OUTCOME IN HUMANS (CTOT-01, CTOT-05)
DOI: 10.21430/M3ADHQNPY9
Subjects: 47
Study PI, contact:
NameOrganizationSite
Peter Heeger Mount Sinai School of Medicine Mount Sinai School of Medicine
Publications:
Adverse Outcomes of Tacrolimus Withdrawal in Immune-Quiescent Kidney Transplant Recipients.. J Am Soc Nephrol. Dec 2015. doi: 10.1681/ASN.2014121234. Epub 2015 Apr 29. [Pubmed: 25925687]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT01517984]
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
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Dengue Human Immunology Project Consortium (DHIPC MSSM)
DOI: 10.21430/M3K4G9JI49
Subjects: 43
Study PI, contact:
NameOrganizationSite
Eva Harris University of California, Berkeley University of California, Berkeley
Publications:
Comprehensive innate immune profiling of chikungunya virus infection in pediatric cases.. Mol Syst Biol. Aug 2018. doi: 10.15252/msb.20177862. [Pubmed: 30150281]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 84
Luminex xMAP 90
RNA sequencing 172
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.
Program/Contract:
ProgramContract
Other Programs LC: Hiv Vaccine Trials Network
Other Programs Seattle-Lausanne-Kampala CTU
DOI: 10.21430/M3BY9LGSBH
Subjects: 10
Study PI, contact:
NameOrganizationSite
Julie McElrath Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division
Publications:
Merck Ad5/HIV induces broad innate immune activation that predicts CD8_ T-cell responses but is attenuated by preexisting Ad5 immunity.. PNAS December 2012. doi: https://doi.org/10.1073/pnas.1208972109 [Pubmed: 23151505]
Resources:
Publication http://www.pnas.org/content/109/50/E3503.long]
Clinical Trial https://clinicaltrials.gov/show/NCT00486408?link_type=CLINTRIALGOV&access_num=NCT00486408]
NCBI GEO https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE22768]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 50
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.
Program/Contract:
ProgramContract
Asthma and Allergic Diseases Cooperative Research Centers 1 (AADCRC1) Mechanisms and Enviromental Determinants of Rhinovirus Illness Severity (AADCRC1)
DOI: 10.21430/M3HFAE4ES9
Subjects: 36
Study PI, contact:
NameOrganizationSite
James Gern University of Wisconsin University of Wisconsin
Publications:None
Resources:
Assays:None
Clinical Assessments:
modified Jackson Daily Peak Symptom Scores
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.
Program/Contract:
ProgramContract
Other Programs NIHR Oxford Biomedical Research Centre
DOI: 10.21430/M3Q1ZBWOG2
Subjects: 20
Study PI, contact:
NameOrganizationSite
Daniel O'Connor NIHR Oxford Biomedical Research Centre. University of Oxford
Publications:
High-dimensional assessment of B-cell responses to quadrivalent meningococcal conjugate and plain polysaccharide vaccine.. Genome Medicine January 2017. doi: 10.1186/s13073-017-0400-x [Pubmed: 28137280]
Resources:
PubMed Central https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5282650/]
GEO GSE92884 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE92884]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 59
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.
Program/Contract:
ProgramContract
Other Programs Wellcome Trust
DOI: 10.21430/M3NJTLGRT4
Subjects: 24
Study PI, contact:
NameOrganizationSite
Magali Matsumiya The Jenner Institute University of Oxford
Publications:
Roles for Treg Expansion and HMGB1 Signaling through the TLR1-2-6 Axis in Determining the Magnitude of the Antigen-Specific Immune Response to MVA85A. PLOS One July 2013. doi: 10.1371/journal.pone.0067922 [Pubmed: 23844129]
Resources:
Gene expression analysis of peripheral blood mononuclear cells prior to and following vaccination of human volunteers with the novel TB vaccine candidate MVA85A https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE40719]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 96
Clinical Assessments:None
SDY1365: UC MAIT study
Status: New
Description: Establish whether MAIT cells participate in pathophysiology of UC
Program/Contract:
ProgramContract
Other Programs G. Konijeti Career Development Award
DOI: 10.21430/M3AV8VFYCB
Subjects: 13
Study PI, contact:
NameOrganizationSite
Gauree Konijeti Scripps Clinic Scripps Clinic
Publications:None
Resources:
Scripps Institute https://www.scripps.org/]
Assays:None
Clinical Assessments:
Ulcerative Colitis Assessmet
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.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Vaccination and infection: indicators of immunological health and responsiveness
Cooperative Centers on Human Immunology Adaptive And Innate Immunity, Memory And Repertoire In Vaccination And Infection
DOI: 10.21430/M3P1TK6IXE
Subjects: 18
Study PI, contact:
NameOrganizationSite
Jorg Goronzy Stanford University Stanford University
Publications:
Defective T Memory Cell Differentiation after Varicella Zoster Vaccination in Older Individuals. PLOS Pathogens October 2016. doi: 10.1371/journal.ppat.1005892 [Pubmed: 27764254]
Resources:
GEO GSE86332 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE86332]
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01911065]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 36
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.
Program/Contract:
ProgramContract
NIH Program Stage-Specific Inhibitors Of Orthopoxviruses
DOI: 10.21430/M3QHF445NF
Subjects: 8
Study PI, contact:
NameOrganizationSite
Judy Yen Boston University School of Medicine Boston University School of Medicine
Publications:None
Resources:
NCBI GEO GSE22121 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE22121]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 142
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.
Program/Contract:
ProgramContract
Other Programs German Center for Infection Research (DZIF)
DOI: 10.21430/M33F47FE9U
Subjects: 18
Study PI, contact:
NameOrganizationSite
Lorenzo Hadrien INSERM/INRIA SISTM, Biostatistiques, INSERM/INRIA
Publications:
Systems Vaccinology Identifies an Early Innate Immune Signature as a Correlate of Antibody Responses to the Ebola Vaccine rVSV-ZEBOV.. Cell Rep. Aug 2017. doi: 10.1016/j.celrep.2017.08.023. [Pubmed: 28854372]
Resources:
GEO_GSE97590 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=gse97590]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 56
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.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Biological Analysis of Innate and Adaptive Responses to Vaccination
NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) Influenza Pathogenesis & Immunology Research Center (IPIRC)
DOI: 10.21430/M3H9N1SFLO
Subjects: 30
Study PI, contact:
NameOrganizationSite
Bali Pulendran Emory University Emory Vaccine Center,
Publications:
Systems biology of vaccination for seasonal influenza in humans.. Nat Immunol. Jul 2011. doi: 10.1038/ni.2067. [Pubmed: 21743478]
Systems Analysis of Immunity to Influenza Vaccination across Multiple Years and in Diverse Populations Reveals Shared Molecular Signatures.. Immunity. Dec 2015. doi: 10.1016/j.immuni.2015.11.012. [Pubmed: 26682988]
Resources:
Emory Vaccine Center http://www.vaccines.emory.edu/]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 168
Q-PCR 90
Transcription profiling by array 83
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.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3WZ7XK2GG
Subjects: 92
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford-LPCH Vaccine Program
Publications:None
Resources:
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 91
Flow Cytometry 445
Hemagglutination Inhibition 178
HLA Typing 81
Virus Neutralization 178
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
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (HIPC2)
DOI: 10.21430/M3D02NOSVH
Subjects: 60
Study PI, contact:
NameOrganizationSite
Bjoern Peters La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
An Integrated Workflow To Assess Technical and Biological Variability of Cell Population Frequencies in Human Peripheral Blood by Flow Cytometry.. J Immunol. Feb 2017. doi: 10.4049/jimmunol.1601750. Epub 2017 Jan 9. [Pubmed: 28069807]
Transcriptomic Analysis of CD4+ T Cells Reveals Novel Immune Signatures of Latent Tuberculosis.. J Immunol. Mar 2018. doi: - [Pubmed: 29602771]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 60
HLA Typing 60
RNA sequencing 85
Clinical Assessments:None
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