DR17 DataRelease

SDY63: Immunologic and genomic signatures of influenza vaccine response - 2010 (see companion studies SDY400, SDY404, SDY520)
Status: New
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Defining signatures for immune responsiveness by functional systems immunology HIPC1
DOI: 10.21430/M38WXGBDTS
Subjects: 49
Study PI, contact:
NameOrganizationSite
David Hafler Yale Yale
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 90
Transcription profiling by array 288
Clinical Assessments:None
SDY296: Systems Biology Approach to Analysis of 2011-12 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY74, SDY301)
Status: New
Description: This project will contribute to the overall vision and goals of this U19 by analyzing the immune response to Flu vaccination in healthy individuals. The knowledge generated in this Project will be transferred to Projects 3-5 where immune effects of vaccination will be studied in patients with underlying immune system alterations.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M300RMFHZQ
Subjects: 45
Study PI, contact:
NameOrganizationSite
A. Karolina Palucka Baylor Research Institute Baylor Research Institute
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 219
Flow Cytometry 975
Hemagglutination Inhibition 74
Nanostring 36
Sequencing 42
Virus Neutralization 74
Clinical Assessments:
Vaccination History
SDY301: Systems Biology Approach to Analysis of 2012-13 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY74, SDY296)
Status: New
Description: This project will contribute to the overall vision and goals of this U19 by analyzing the immune response to Flu vaccination in healthy individuals. The knowledge generated in this Project will be transferred to Projects 3-5 where immune effects of vaccination will be studied in patients with underlying immune system alterations.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3T0BGMGGC
Subjects: 40
Study PI, contact:
NameOrganizationSite
A. Karolina Palucka Baylor Research Institute Baylor Research Institute
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 213
Flow Cytometry 642
Hemagglutination Inhibition 240
Nanostring 38
Sequencing 108
Virus Neutralization 240
Clinical Assessments:
Vaccination History
SDY400: Immunologic and genomic signatures of influenza vaccine response - 2012 (see companion studies SDY63, SDY404, SDY520)
Status: New
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year3 2012
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Defining signatures for immune responsiveness by functional systems immunology HIPC1
DOI: 10.21430/M3U7GDOFIT
Subjects: 98
Study PI, contact:
NameOrganizationSite
David Hafler Yale Yale
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 187
Transcription profiling by array 356
Clinical Assessments:None
SDY404: Immunologic and genomic signatures of influenza vaccine response - 2011 (see companion studies SDY63, SDY400, SDY520)
Status: New
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year2 2011
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Defining signatures for immune responsiveness by functional systems immunology HIPC1
DOI: 10.21430/M3GWQRC8DT
Subjects: 72
Study PI, contact:
NameOrganizationSite
David Hafler Yale Yale
Publications:
Prolonged proinflammatory cytokine production in monocytes modulated by interleukin 10 after influenza vaccination in older adults.. J Infect Dis. Apr 2015. doi: 10.1093/infdis/jiu573. Epub 2014 Nov 2. [Pubmed: 25367297]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 2062
Hemagglutination Inhibition 138
Transcription profiling by array 512
Clinical Assessments:None
SDY6: ADVN Biomarker Registry Study
Status: Updated
Description: This protocol describes the development of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) Biomarker Registry Study. The proposed Registry is a database with a minimum of 1,000 subjects who have voluntarily agreed to provide medical and demographic information about themselves and their health status.

These data will be collected until a minimum of 12 weeks prior to the end of the funding cycle to allow for final data entry, query resolution, and database lock and will be used to identify potential subjects for future studies designed to improve scientific understanding of the increased risk of complications after exposure to the smallpox vaccine for people with atopic dermatitis (AD).

In addition, enrolled subjects will be asked to provide a blood sample for evaluation of biomarkers, and permission for blood sample storage to support future analyses. Provision of a blood sample for evaluation of biomarkers for future analyses will be optional for subjects under 6 years of age.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3J22ZOZM9
Subjects: 1231
Study PI, contact:
NameOrganizationSite
Lisa Beck University of Rochester Medical Center University of Rochester Medical Center
Publications:None
Resources:
NIH Reporter https://projectreporter.nih.gov/project_info_details.cfm?aid=9042233&icde=33171050]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 236
Clinical Assessments:
Affected body surface area for Atopic dermatitis subject
Allergy History
Any Adverse Event?
Any medications taken
Atopic Dermatitis Assessment
Atopic dermatitis supplemental information
CBC Panic values
Confirmation of Diagnostic Category
Current Medical History
EASI Score
Eczema Herpeticum Assessment
EV Assessment
Family History
Health Status
Initial diagnosis
Interim Medical History
Interim Skin Infection History
Medical History
Molluscum Contagiosum Assessment
Non-AD Assessment
Original Diagnosis
Physical Exam
Rajka-Langeland Score
Skin Infection History
Skin/Integument exam
Staphylococcus aureus infection history for previously enrolled subject
Staphylococcus Aureus Infection History Questionnaire
Vaccination history
SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling
Status: Updated
Description: Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling
DOI: 10.21430/M3OYWCJHO1
Subjects: 159
Study PI, contact:
NameOrganizationSite
Gregory Poland Mayo Clinic Mayo Clinic
Publications:
The impact of immunosenescence on humoral immune response variation after influenza A/H1N1 vaccination in older subjects.. PLoS One. Mar 2015. doi: 10.1371/journal.pone.0122282. eCollection 2015. [Pubmed: 25816015]
System-Wide Associations between DNA-Methylation, Gene Expression, and Humoral Immune Response to Influenza Vaccination.. PLoS One. Mar 2016. doi: 10.1371/journal.pone.0152034. eCollection 2016. [Pubmed: 27031986]
Gene signatures related to HAI response following influenza A/H1N1 vaccine in older individuals.. Heliyon. May 2016. doi: 10.1016/j.heliyon.2016.e00098. eCollection 2016. [Pubmed: 27441275]
Simultaneous enumeration of cancer and immune cell types from bulk tumor gene expression data.. Elife. Nov 2017. doi: 10.7554/eLife.26476. [Pubmed: 29130882]
Resources:
NIH Reporter 5U01AI089859-05 http://projectreporter.nih.gov/project_info_details.cfm?aid=8695082]
Assays:
Assay TypeNumber of Exp. Samples
Cell Culture 556
DNA methylation profiling assay 952
ELISPOT 1113
Flow Cytometry 3387
Hemagglutination Inhibition 1272
Mass Spectrometry 61
Meso Scale Discovery ECL 1272
PCR 466
Q-PCR 159
RNA sequencing 1100
Virus Neutralization 635
Clinical Assessments:None
SDY74: Systems Biology Approach to Analysis of 2010-11 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY301, SDY296)
Status: Updated
Description: This study will measure the immune response to the influenza vaccine The long-term goal is to develop improved vaccines to infectious diseases such as influenza. Blood will be collected from patients at several visits before and after vaccination. The blood will be used in a series of immunological tests to measure the strength and breadth of immune response. These assays may include T cell and B cell activation assays, microarray testing, Epimax, Epigen, and flow cytometry.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3EJ72RVRG
Subjects: 12
Study PI, contact:
NameOrganizationSite
A. Karolina Palucka Baylor Research Institute Baylor Research Institute
Publications:
Induction of ICOS+CXCR3+CXCR5+ TH cells correlates with antibody responses to influenza vaccination.. Sci Transl Med. Mar 2013. doi: 10.1126/scitranslmed.3005191. [Pubmed: 23486778]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 60
Flow Cytometry 459
Clinical Assessments:
Vitals
SDY144: Systems Biology Approach to Study Influenza Vaccine 2011-12 in Healthy Children (see companion studies SDY364, SDY368, SDY387)
Status: Updated
Description: The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures.

The assay results from SDY144's EXP13603, EXP11769, and EXP13604 are the same as for this study. The difference is how the floe cytometry results were analyzed in this study versus SDY144.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3ANETOJEC
Subjects: 17
Study PI, contact:
NameOrganizationSite
Octavio Ramilo Nationwide Children's Hospital Nationwide Children's Hospital
Publications:
Differences in antibody responses between trivalent inactivated influenza vaccine and live attenuated influenza vaccine correlate with the kinetics and magnitude of interferon signaling in children.. J Infect Dis. Jul 2014. doi: 10.1093/infdis/jiu079. Epub 2014 Feb 4. [Pubmed: 24495909]
Resources:
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE52005]
EMBL-EBI http://www.ebi.ac.uk/arrayexpress/experiments/E-GEOD-52005/]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 64
Flow Cytometry 486
Hemagglutination Inhibition 32
Virus Neutralization 96
Clinical Assessments:
Medical History
Vaccination History
Vital Signs
SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine
Status: Updated
Description: Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3I44H8R17
Subjects: 46
Study PI, contact:
NameOrganizationSite
A. Karolina Palucka Baylor Reasearch Institute Baylor Reasearch Institute
Publications:
Systems scale interactive exploration reveals quantitative and qualitative differences in response to influenza and pneumococcal vaccines.. Immunity. Apr 2013. doi: 10.1016/j.immuni.2012.12.008. [Pubmed: 23601689]
Resources:
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE30101]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 542
Flow Cytometry 2208
Hemagglutination Inhibition 66
Luminex xMAP 229
Nanostring 18
Transcription profiling by array 161
Virus Neutralization 89
Clinical Assessments:None
SDY546: FACTOR ITN507ST: Study of Tolerant Kidney Transplant Recipients
Status: Updated
Description: Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the bodys immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as immunosuppressive or anti-rejection drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to tolerate the transplanted kidney, and this condition is referred to as tolerance. In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance. Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010).
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3SBI9FQPC
Subjects: 96
Study PI, contact:
NameOrganizationSite
Kenneth Newell Emory University Immune Tolerance Network
Publications:
Identification of a B cell signature associated with renal transplant tolerance in humans.. J Clin Invest. Jun 2010. doi: 10.1172/JCI39933. Epub 2010 May 24. [Pubmed: 20501946]
Donor-specific indirect pathway analysis reveals a B-cell-independent signature which reflects outcomes in kidney transplant recipients.. Am J Transplant. Mar 2012. doi: 10.1111/j.1600-6143.2011.03869.x. Epub 2011 Dec 7. [Pubmed: 22151236]
Longitudinal studies of a B cell-derived signature of tolerance in renal transplant recipients.. Am J Transplant. Nov 2015. doi: 10.1111/ajt.13480. Epub 2015 Oct 13. [Pubmed: 26461968]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT01338779]
ITNTrialShare.org https://www.itntrialshare.org/project/Studies/ITN507STPUBLIC/Study%20Data/begin.view]
Gene Expression Omnibus http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE22229]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 46
Clinical Assessments:None
SDY662: WISP-R ITN029ST: Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Status: Updated
Description: Immunosuppressive drugs are prescribed to organ transplant recipients to prevent organ rejection. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from pediatric liver transplant recipents
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3QJJF9A71
Subjects: 25
Study PI, contact:
NameOrganizationSite
Sandy Feng University of California, San Francisco Immune Tolerance Network
Publications:
Complete immunosuppression withdrawal and subsequent allograft function among pediatric recipients of parental living donor liver transplants.. JAMA. Jan 2012. doi: 10.1001/jama.2011.2014. [Pubmed: 22253395]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT00320606]
Immune Tolerance Network (ITN) Trialshare https://www.itntrialshare.org/project/Studies/ITN029STPUBLIC/Study%20Data/begin.view]
Assays:None
Clinical Assessments:
Allograft_Dysfunction
SDY668: Miller-Burke ITN022ST: Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
Status: Updated
Description: Alemtuzumab is used to treat certain blood disorders. This study evaluates kidney transplant recipients treated with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3QZ1A9OOE
Subjects: 9
Study PI, contact:
NameOrganizationSite
George Burke University of Miami Immune Tolerance Network
Publications:None
Resources:
Clinicaltrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT00183248]
Immune Tolerance Network Trialshare https://www.itntrialshare.org]
Assays:None
Clinical Assessments:
Overall_Outcome_Data
SDY671: Knechtle ITN013ST: Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Status: Updated
Description: This study will evaluate the effects of intravenous (IV) alemtuzumab and oral sirolimus and tacrolimus after kidney transplantation. The study will also evaluate this regimen's potential to allow eventual discontinuation of components of long-term immunosuppressive therapy. Study duration will be 4 years. Participants will undergo kidney transplantation on Day 0, receive IV doses of alemtuzumab, acetaminophen, and diphenhydramine on Days 0, 1, and 2, as well as methylprednisolone on Day 0. Patients will receive up to 10 days of valganciclovir or acyclovir post transplant. Daily oral doses of tacrolimus will contiue for 60 days and sirolimus daily by mouth for at least 12 months after transplant. Participants will take sulfamethoxazole-trimethoprim 3 times a week, valganciclovir or acyclovir for up to 10 days post-transplant, and clotrimazole or nystatin by mouth for at least 3 months post-transplant. Sixty-to study visits are planned to be spread out over 4 years post transplant. Sirolimus withdrawal process will occur over a minimum of 3 months at an approximate rate of 33% of the pre-withdrawal dose per month. Participants eligible for sirolimus withdrawal will undergo several kidney biopsies, including one 2 weeks prior to the start of withdrawal, 6 and 12 months after completion of withdrawal, 1 year after study enrollment, and annually thereafter.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M38BB6XTX9
Subjects: 20
Study PI, contact:
NameOrganizationSite
Stuart Knechtle Emory University Immune Tolerance Network
Arjang Djamali University of Wisconsin, Madison Immune Tolerance Network
Publications:
Early and limited use of tacrolimus to avoid rejection in an alemtuzumab and sirolimus regimen for kidney transplantation: clinical results and immune monitoring.. Am J Transplant. May 2009. doi: 10.1111/j.1600-6143.2009.02581.x. Epub 2009 Mar 16. [Pubmed: 19344431]
Longitudinal studies of a B cell-derived signature of tolerance in renal transplant recipients.. Am J Transplant. Nov 2015. doi: 10.1111/ajt.13480. Epub 2015 Oct 13. [Pubmed: 26461968]
Resources:
Clinicaltrials.gov https://www.clinicaltrials.gov/ct2/show/record/NCT00078559]
Immune Tolerance Network Trialshare https://www.itntrialshare.org]
Assays:None
Clinical Assessments:
Overall_Outcome_Data
SDY674: Vincenti ITN023ST: Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Status: Updated
Description: Participants, at the time of transplant, begin immunosuppressive treatment with belatacept, sirolimus and thymoglobulin. Dose reduction of belatacept begins at 12 weeks post-transplant. Drug withdrawal begins at year 2.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3W336PE8D
Subjects: 10
Study PI, contact:
NameOrganizationSite
Flavio Vincenti University of California, San Francisco University of California, San Francisco
Publications:
Costimulation blockade with belatacept in renal transplantation.. N Engl J Med. Aug 2005. doi: - [Pubmed: 16120857]
Resources:
Clinicaltrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT00346151]
Immune Tolerance Network Trialshare https://www.itntrialshare.org]
Assays:None
Clinical Assessments:
Overall Outcome
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