DR19 DataRelease

SDY293: Live Lung Donor Retrospective Study (RELIVE-02)
Status: New
Description: The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M3495BHP30
Subjects: 369
Study PI, contact:
NameOrganizationSite
Akinlolu Ojo University of Michigan University of Michigan
Publications:
Morbidity and mortality of live lung donation: results from the RELIVE study.. Am J Transplant. Aug 2014. doi: - [Pubmed: 25039865]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00553397]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7099088&icde=26162525]
Assays:None
Clinical Assessments:None
SDY479: Urinary cell mRNA profiles of rejection (CTOT-04)
Status: New
Description: This is an observational, uncontrolled and non-randomized study in which all deceased donor and living donor kidney allograft recipients at all participating centers are eligible for enrollment. The primary aims are : (1) To investigate whether the levels of mRNA encoding cytotoxic proteins perforin and granzyme B, and T cell marker CD3, are a sensitive and specific noninvasive diagnostic test for acute rejection in renal allografts; and (2) To determine whether mRNA profiles of sequential urine specimens predict the development of rejection. We will investigate whether mRNA profiles predict kidney graft function as assessed by estimated GFR at 12, 24 and 36 months after transplantation.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) MOLECULAR PROFILING AND IMMUNOMODULATORY INTERVENTIONS (CTOT-03, CTOT-04)
DOI: 10.21430/M3YP3ROBVT
Subjects: 494
Study PI, contact:
NameOrganizationSite
Abraham Shaked University of Pennsylvania Medical Center, Department of Surgery University of Pennsylvania Medical Center, Department of Surgery
Publications:
Urinary-cell mRNA profile and acute cellular rejection in kidney allografts.. N Engl J Med. Jul 2013. doi: 10.1056/NEJMoa1215555. [Pubmed: 23822777]
Urine Metabolite Profiles Predictive of Human Kidney Allograft Status.. J Am Soc Nephrol. Feb 2016. doi: 10.1681/ASN.2015010107. Epub 2015 Jun 5. [Pubmed: 26047788]
Resources:
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00337220]
NIH Reporter https://projectreporter.nih.gov/project_info_description.cfm?aid=6875931]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 984
Q-PCR 3883
Clinical Assessments:
Biopsy
Graft Loss
Rejection
SDY557: Noninvasive Monitoring in Kidney Transplantation (CTOT-01)
Status: New
Description: This is a non randomized observational study to assess the sensitivity, specificity, and predictive value of a panel of noninvasive monitoring tests as correlates with acute rejection, graft loss, deterioration of renal function, and degree of graft fibrosis in renal allograft recipients receiving commonly used immunosuppressive regimens.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) NONINVASIVE MARKERS AND TRANSPLANT OUTCOME IN HUMANS (CTOT-01, CTOT-05)
DOI: 10.21430/M3OPJVGUBK
Subjects: 280
Study PI, contact:
NameOrganizationSite
Peter Heeger Mount Sinai School of Medicine, Ricanati Miller Transplant Institute Mount Sinai School of Medicine
Publications:
Standardization and cross validation of alloreactive IFN-gamma ELISPOT assays within the clinical trials in organ transplantation consortium.. Am J Transplant. Jul 2013. doi: 10.1111/ajt.12286. Epub 2013 May 24. [Pubmed: 23710568]
Comprehensive assessment and standardization of solid phase multiplex-bead arrays for the detection of antibodies to HLA.. Am J Transplant. Jul 2013. doi: 10.1111/ajt.12287. Epub 2013 Jun 13. [Pubmed: 23763485]
Multicenter evaluation of a standardized protocol for noninvasive gene expression profiling.. Am J Transplant. Jul 2013. doi: 10.1111/ajt.12284. [Pubmed: 23802725]
Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury.. Am J Transplant. Oct 2013. doi: 10.1111/ajt.12426. Epub 2013 Aug 22. [Pubmed: 23968332]
Optimization for peptide sample preparation for urine peptidomics.. Clin Proteomics. Feb 2014. doi: 10.1186/1559-0275-11-7. [Pubmed: 24568099]
Interferon Gamma ELISPOT Testing as a Risk-Stratifying Biomarker for Kidney Transplant Injury: Results From the CTOT-01 Multicenter Study.. Am J Transplant. Dec 2015. doi: 10.1111/ajt.13401. Epub 2015 Jul 30. [Pubmed: 26226830]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00308802]
NIH Reporter https://projectreporter.nih.gov/project_info_description.cfm?aid=6875911]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 1232
ELISPOT 3771
HLA Typing 560
Luminex xMAP 2102
Q-PCR 1935
Clinical Assessments:
Biopsy
Death
Rejection
SDY571: Observational Study of Alloimmunity in Cardiac Transplant Recipients (CTOT-05)
Status: New
Description: A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) NONINVASIVE MARKERS AND TRANSPLANT OUTCOME IN HUMANS (CTOT-01, CTOT-05)
DOI: 10.21430/M3AG2C6125
Subjects: 200
Study PI, contact:
NameOrganizationSite
Peter Heeger Ricanati Miller Transplant Institute, Mount Sinai School of Medicine Mount Sinai School of Medicine
Mohamed Sayegh Brigham and Women's Hospital, Harvard Medical School Brigham and Women's Hospital, Harvard Medical School
Publications:
Comprehensive assessment and standardization of solid phase multiplex-bead arrays for the detection of antibodies to HLA.. Am J Transplant. Jul 2013. doi: 10.1111/ajt.12287. Epub 2013 Jun 13. [Pubmed: 23763485]
Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study.. Am J Transplant. Jan 2016. doi: 10.1111/ajt.13422. Epub 2015 Aug 10. [Pubmed: 26260101]
P2X7R mutation disrupts the NLRP3-mediated Th program and predicts poor cardiac allograft outcomes.. J Clin Invest. Aug 2018. doi: 10.1172/JCI94524. Epub 2018 Jul 16. [Pubmed: 30010623]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00466804]
NIH Reporter https://projectreporter.nih.gov/project_info_description.cfm?aid=6875911]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 185
ELISPOT 585
HLA Typing 386
Q-PCR 1300
Clinical Assessments:
Biopsy
Death
Intravascular Ultrasound
SDY670: Molecular Profiling of Donor and Recipient Proinflammatory and Allograft Response (CTOT-03)
Status: New
Description: Inflammation and injuries to transplanted organs during the immediate post-operative period may be linked to early organ dysfunction and higher rates of transplant rejection in the recipient. Currently, mRNA expression of proinflammatory genes in donor tissues is thought to be a risk factor for early organ transplant dysfunction, increased expression of the recipients cell-mediated immunity genes, and organ rejection. The purpose of this study is to test the association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in kidney, lung, and liver transplant recipients. This study will also test the effects of proinflammatory mediators expressed in the transplanted organ pre- and post-reperfusion on organ rejection and genes expressed in cell mediated immune responses. This will be achieved by identifying the proinflammatory immune responses and their mechanisms.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) MOLECULAR PROFILING AND IMMUNOMODULATORY INTERVENTIONS (CTOT-03, CTOT-04)
DOI: 10.21430/M3GLG1R2NY
Subjects: 311
Study PI, contact:
NameOrganizationSite
Abraham Shaked University of Pennsylvania Medical Center University of Pennsylvania Medical Center
Publications:
Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors.. Liver Transpl. Aug 2010. doi: 10.1002/lt.22091. [Pubmed: 20677285]
Gene set enrichment analysis identifies key innate immune pathways in primary graft dysfunction after lung transplantation.. Am J Transplant. Jul 2013. doi: 10.1111/ajt.12283. Epub 2013 May 24. [Pubmed: 23710539]
Peripheral Blood Gene Expression Changes Associated With Primary Graft Dysfunction After Lung Transplantation.. Am J Transplant. Jul 2017. doi: 10.1111/ajt.14209. Epub 2017 Feb 17. [Pubmed: 28117940]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct/show/NCT00531921]
NIH RePORTER http://projectreporter.nih.gov/project_info_description.cfm?aid=6875931&icde=25772230]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 286
HLA Typing 495
Clinical Assessments:
Biopsy
Echocardiogram
Electrocardiogram
Pathology
Rejection
SDY689: B-Cell depletion by anti-CD20 in renal allograft recipients who develop de novo anti-HLA alloantibodies
Status: New
Description: The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan, MabThera) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney. The pilot study compares the use of rituximab (Rituxan) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) NOVEL THERAPIES OF CHRONIC ALLOGRAFT DYSFUNCTION (CTOT-02)
DOI: 10.21430/M3VC8YZQ9K
Subjects: 757
Study PI, contact:
NameOrganizationSite
Mohamed Sayegh Brigham and Women's Hospital Brigham and Women's Hospital
Publications:None
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct/show/NCT00307125]
NIH Reporter http://projectreporter.nih.gov/project_info_description.cfm?aid=6880173]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 1507
Clinical Assessments:
Biopsy
Death
Graft Failure
Rejection
SDY788: Immune Profiles to Predict Response to Desensitization Therapy in Highly HLA-Sensitized Kidney Transplant Candidates
Status: New
Description: Single-cell mass cytometry by time-of-flight (CyTOF) phenotyping, gene arrays, and phosphoepitope flow cytometry were performed in 20 highly sensitized kidney transplant candidates undergoing desensitization therapy.
Program/Contract:
ProgramContract
Improving Kidney Transplant Outcomes By Using Novel B-cell Immune Profiling Improving Kidney Transplant Outcomes By Using Novel B-cell Immune Profiling
DOI: 10.21430/M3R0UUBC6K
Subjects: 22
Study PI, contact:
NameOrganizationSite
Julie Yabu Stanford University Stanford
Publications:
Immune Profiles to Predict Response to Desensitization Therapy in Highly HLA-Sensitized Kidney Transplant Candidates.. PLoS One. Apr 2016. doi: 10.1371/journal.pone.0153355. eCollection 2016. [Pubmed: 27078882]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 141
DNA microarray 39
Flow Cytometry 360
Clinical Assessments:None
SDY789: Temporal Response to seasonal and pandemic H1N1 infection in human DCs
Status: New
Description: Purpose: mRNA expression analysis of DC response to influenza viruses. Experiment variables (brief description of biological sample treatments and time points): human mDCs are infected with H1N1 influenza viruses (IAV) Brevig/1918, California/09, New Caledonia/99 and Texas/91 for 2, 2.4, 3.2, 4, 5, 6, 7 and 8 hours. RNA is isolated and hybridized to gene expression microarrays
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Mount Sinai School of Medicine Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3I7TJB7L2
Subjects: 2
Study PI, contact:
NameOrganizationSite
Stuart Sealfon ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Publications:
Human Dendritic Cell Response Signatures Distinguish 1918, Pandemic, and Seasonal H1N1 Influenza Viruses.. J Virol. Oct 2015. doi: 10.1128/JVI.01523-15. Epub 2015 Jul 29. [Pubmed: 26223639]
Resources:
NIH Reporter https://projectreporter.nih.gov/project_info_description.cfm?aid=8159582&icde=29095415]
PRiME http://tsb.mssm.edu/primeportal/?q=Immunet_interactive_networks]
Gene Expression Omnibus http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE55278]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 240
Clinical Assessments:None
SDY797: T1DAL ITN045AI: Inducing Remission in New Onset Type 1 Diabetes Mellitus with Alefacept(Amevive)
Status: New
Description: T1DM is an autoimmune disease that can emerge suddenly, causing dependence on insulin for life. This means that the immune system (the part of your body that helps fight infections) mistakenly attacks the cells in the pancreas that produce insulin (beta cells). As beta cells are destroyed, one's ability to produce insulin is decreased. Insulin helps keep blood glucose (sugar) levels normal.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3F6ZX0TRG
Subjects: 49
Study PI, contact:
NameOrganizationSite
Mark R Rigby Indiana University and Riley Hospital for Children Indiana University
Publications:
Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results of a randomised, double-blind, placebo-controlled phase 2 trial.. Lancet Diabetes Endocrinol. Dec 2013. doi: 10.1016/S2213-8587(13)70111-6. Epub 2013 Sep 23. [Pubmed: 24622414]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00965458]
Immune Tolerance Network https://www.itntrialshare.org/project/Studies/ITN045AIJCI/Study%20Data/begin.view]
Assays:None
Clinical Assessments:None
SDY798: Diamond-Wofsy ITN002AI: Treating Systemic Lupus Erythematosus (SLE) Patients with CTLA4-IgG4m (RG2077)
Status: New
Description: SLE is a chronic, inflammatory autoimmune disorder that may affect many organ systems, including the skin, joints, and internal organs. RG2077 has been studied for use in multiple sclerosis, another autoimmune disorder. This study will evaluate the safety and efficacy of RG2077 in SLE patients who are currently receiving cyclophosphamide.This trial is composed of two parts. The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 (0.2 mg/kg or 2 mg/kg); this part of the study will last 60 days. At screening, patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077. Patients will also have medical and medication history assessments, a comprehensive physical exam, and blood and urine tests. There are 5 study visits for the first part of the trial; these will occur at screening, at study entry, and Days 1, 14, and 28. Selected visits will include physical exam, vital signs measurement, blood and urine tests, and disease activity assessment. At Days 7 and 60, patients will be contacted by phone to report their medication history and any adverse effects they have experienced.The second part of the study will evaluate a single 10 mg/kg dose of RG2077; this part of the study will last 90 days. In the study, participants will be randomly assigned to one of two groups. At the start of the study, Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only. There will be 9 study visits; these will occur at study screening, study entry, and Days 1, 4, 7, 14, 28, and 60. At selected visits, patients will undergo physical exam, vital signs measurement, blood tests and urine tests, and disease activity assessment.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3PU4TFQBF
Subjects: 6
Study PI, contact:
NameOrganizationSite
David Wofsy University of California, San Francisco University of California, San Francisco
Betty Diamond Columbia University Columbia University
Publications:
Block and tackle: CTLA4Ig takes on lupus.. Lupus. - 2005. doi: - [Pubmed: 15807196]
Resources:
ITN Trial Share https://www.itntrialshare.org/project/Studies/ITN002AIPUBLIC/Study%20Data/begin.view]
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00094380]
Assays:None
Clinical Assessments:
SkinTest_SDY798
SDY816: Systems Biology Analysis of the response to Licensed Hepatitis B Vaccine (HEPLISAV) in specific cell subsets (see companion studies SDY299 and SDY690)
Status: New
Description: None
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3HV9NRS67
Subjects: 10
Study PI, contact:
NameOrganizationSite
Robert Coffman Dynavax Technologies Corporation Dynavax Technologies Corporation
Publications:
Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine.. Vaccine. Mar 2012. doi: 10.1016/j.vaccine.2012.02.001. Epub 2012 Feb 14. [Pubmed: 22342916]
Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age.. Vaccine. Nov 2013. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30. [Pubmed: 23727002]
Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18-70 years of age.. Vaccine. Jul 2015. doi: 10.1016/j.vaccine.2015.05.070. Epub 2015 Jun 9. [Pubmed: 26067185]
None. None None None. doi: None [Pubmed: 29289383]
Resources:
NA NA]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 509
Clinical Assessments:None
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
SDY91: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE ITN021AI)
Status: Updated
Description:

Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA).

The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.

Participants will then be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit.

Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE), Immune Tolerance Network
DOI: 10.21430/M3TK42R0QR
Subjects: 197
Study PI, contact:
NameOrganizationSite
Ulrich Specks Mayo Clinic Mayo Clinic
John H. Stone Johns Hopkins University Johns Hopkins University
Publications:
Rituximab versus cyclophosphamide for ANCA-associated vasculitis.. N Engl J Med. Jul 2010. doi: 10.1056/NEJMoa0909905. [Pubmed: 20647199]
Circulating markers of vascular injury and angiogenesis in antineutrophil cytoplasmic antibody-associated vasculitis.. Arthritis Rheum. Dec 2011. doi: 10.1002/art.30615. [Pubmed: 21953143]
Circulating angiopoietin-2 as a biomarker in ANCA-associated vasculitis.. PLoS One. - 2012. doi: 10.1371/journal.pone.0030197. Epub 2012 Jan 18. [Pubmed: 22279570]
Efficacy of remission-induction regimens for ANCA-associated vasculitis.. N Engl J Med. Aug 2013. doi: 10.1056/NEJMoa1213277. [Pubmed: 23902481]
Pro: Should all patients with anti-neutrophil cytoplasmic antibody-associated vasculitis be primarily treated with rituximab?. Nephrol Dial Transplant. Jul 2015. doi: 10.1093/ndt/gfv217. Epub 2015 May 21. [Pubmed: 25999375]
Reanalysis of the Rituximab in ANCA-Associated Vasculitis trial identifies granulocyte subsets as a novel early marker of successful treatment.. Arthritis Res Ther. Sep 2015. doi: 10.1186/s13075-015-0778-z. [Pubmed: 26387933]
Design of the Rituximab in ANCA-associated Vasculitis (RAVE) Trial.. The Open Arthritis Journal Nov 2011. doi: 10.2174/1876539401104010001 [Pubmed: TBD_A]
Resources:
ImmuneTolerance.org http://www.immunetolerance.org/]
ImmuneTolerance.org https://www.itntrialshare.org/]
Clinicaltrials.gov http://clinicaltrials.gov/ct2/show/NCT00104299]
The Open Arthritis Journal https://www.immunetolerance.org/sites/files/2011.11%20OpenArthritisJournal_Specks%20%28RAVE%20Design%29.pdf]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 1175
Flow Cytometry 1151
Clinical Assessments:
Assignment
Baseline Height (cm)
Baseline Weight (kg)
BVAS/WG
Diagnosis
Flares
Prednisone Taper
Remission
SF-36
Vasculitis Damage Index
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
SDY167: VRC304 - A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP) Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults
Status: Updated
Description: The primary objective was to evaluate the safety and tolerability of an investigational vaccine VRC-AVIDNA036-00-VP in humans at doses 1 mg and 4 mg administered intramuscularly using a needle-free injection system. The secondary objectives included evaluation of whether VRC-AVIDNA036-00-VP (at doses 1 mg and 4 mg) induced antibodies as assessed by an HAI assay at Day 0 and Week 12. Exploratory analyses included evaluation of the immunogenicity of VRC-AVIDNA036-00-VP at doses 1 mg and 4 mg using intracellular cytokine staining, ELISpot, neutralizing antibody assay, HAI assay to H1 or H3HA or other immunological assays at time intervals between Day 0 and Week 42.
Program/Contract:
ProgramContract
NIAID Vaccine Research Center (VRC) NIAID Vaccine Research Center (VRC)
DOI: 10.21430/M3SGHW16WZ
Subjects: 45
Study PI, contact:
NameOrganizationSite
Julie Ledgerwood Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID)
Publications:
Influenza virus h5 DNA vaccination is immunogenic by intramuscular and intradermal routes in humans.. Clin Vaccine Immunol. Nov 2012. doi: 10.1128/CVI.05663-11. Epub 2012 Sep 5. [Pubmed: 22956656]
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT00408109]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 430
ELISPOT 300
Flow Cytometry 874
Hemagglutination Inhibition 44
Virus Neutralization 88
Clinical Assessments:None
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
SDY210: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies
Status: Updated
Description: Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits. ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether highly sensitized, compared to weakly sensitized asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3I0JL7KUZ
Subjects: 546
Study PI, contact:
NameOrganizationSite
William Busse University of Wisconsin, Madison University of Wisconsin, Madison
Publications:
Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial.. Lancet. Sep 2008. doi: 10.1016/S0140-6736(08)61448-8. [Pubmed: 18805335]
Asthma severity, not asthma control, is worse in atopic compared with nonatopic adolescents with asthma.. Ann Allergy Asthma Immunol. Jan 2016. doi: 10.1016/j.anai.2015.10.015. Epub 2015 Nov 7. [Pubmed: 26560898]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct/show/NCT00114413]
Assays:None
Clinical Assessments:None
SDY211: Inner-City Anti-IgE Therapy for Asthma
Status: Updated
Description: This study is testing a medication called omalizumab for the treatment of asthma. Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause inflammation in the lungs. Omalizumab can reduce inflammation and asthma attacks by blocking IgE. Unlike other medications for asthma, omalizumab is not an inhaler medication or pill. Instead, omalizumab is dissolved in a liquid and given by injection. Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas. The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone. This study will recruit inner-city children and adolescents with moderate to severe allergic asthma. This study will last about 1.5 to 2 years. Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks. The injection schedule will be determined based on the participant's weight and total IgE. Both groups will receive standardized specialist care and basic asthma education including environmental control measures. Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study. Participants will complete a series of questionnaires about topics including perceived stress, home environment, physical activity, diet and nutrition, smoking habits, and quality of life. At study entry and monthly throughout the study, participants will complete questionnaires about their asthma symptoms and medical resource utilization. Some visits will include a physical examination, vital signs measurement, lung function tests, asthma medication evaluation, and an asthma action plan. Blood collection is required up to eight times during the study for safety labs.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3V7CAZ3NP
Subjects: 419
Study PI, contact:
NameOrganizationSite
William Busse University of Wisconsin, Madison University of Wisconsin, Madison
Publications:
Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.. N Engl J Med. Mar 2011. doi: 10.1056/NEJMoa1009705. [Pubmed: 21410369]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct/show/NCT00377572]
Assays:None
Clinical Assessments:None
SDY223: A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis
Status: Updated
Description: Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both. At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached. For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home. This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M34X4ULP41
Subjects: 54
Study PI, contact:
NameOrganizationSite
Robert Wood Johns Hopkins University School of Medicine Johns Hopkins University School of Medicine
Publications:None
Resources:
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00829985]
Assays:None
Clinical Assessments:None
SDY224: Immune Responses to Seasonal TIV 2010-2011 Influenza Vaccination in Humans (see companion study SDY396,SDY564)
Status: Updated
Description: High-frequency sampling combined with systems biology analysis of human peripheral blood cells following influenza vaccination was used to investigate T cell and B cell responses. Functional principal component analysis was used to examine time varying B cell vaccine response highlighting a single subject-specific mathematical pattern explaining ninety percent of the transcriptome variation. In addtition, daily sampling and monitoring of the proliferation marker Ki-67, revealed influenza-specific CD4 T cells do respond to vaccination.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II University of Rochester Center for Biodefense Immune Modeling II
DOI: 10.21430/M37KMO7JLW
Subjects: 14
Study PI, contact:
NameOrganizationSite
Hulin Wu University of Rochester Medical Center University of Rochester Medical Center
Martin Zand University of Rochester Medical Center University of Rochester Medical Center
Publications:
Ki-67 expression reveals strong, transient influenza specific CD4 T cell responses after adult vaccination.. Vaccine. Jun 2012. doi: 10.1016/j.vaccine.2012.04.059. Epub 2012 Apr 30. [Pubmed: 22554464]
High-resolution temporal response patterns to influenza vaccine reveal a distinct human plasma cell gene signature.. Sci Rep. - 2013. doi: 10.1038/srep02327. [Pubmed: 23900141]
Resources:
University of Rochester Center for Biodefense Immune Modeling https://cbim.urmc.rochester.edu/]
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/sra?term=SRX259436]
Effect of influenza vaccination on PBMC and B cell gene expression profiles in healthy humans http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE45764]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 423
ELISPOT 120
Flow Cytometry 560
Hemagglutination Inhibition 543
Q-PCR 1548
Sequencing 110
Clinical Assessments:None
SDY269: Systems Biology of 2008 Influenza Vaccination in Humans (See companion studies SDY61 2007 / SDY270 2009 / 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 2008-2009 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/M3CDX6TL4I
Subjects: 63
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/]
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE29615]
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE29617]
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 336
Flow Cytometry 59
Hemagglutination Inhibition 336
Luminex xMAP 168
Q-PCR 75
Transcription profiling by array 263
Clinical Assessments:None
SDY281: Study responses of Adult and neonatal APCs to TLR ligands
Status: Updated
Description: The assays in this study entail stimulation of adult and neonatal blood cells with various concentrations of defined prototype ligands for TLRs 1-9. Multiparameter flow cytometry was used to detect intracellular cytokines (TNF, IL-6, IL-10, IL-12p40, IL-12p70, and IFN-alpha) in whole blood and PBMCs.
Program/Contract:
ProgramContract
Immune Function and Biodefense in Children, Elderly, and Immunocompromised Populations TLRs in Innate Immunity and the Induction of Adaptive Immunity in the Neonate and Infant
DOI: 10.21430/M38S6PGG9Z
Subjects: 80
Study PI, contact:
NameOrganizationSite
Christopher Wilson Department of Immunology University of Washington
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 3596
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: Updated
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: Updated
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
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
SDY315: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2012 (See companion studies SDY311 2010 / SDY312 2009 / SDY314 2008 / 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/M3CJT3NCT2
Subjects: 74
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
CyTOF 74
DNA microarray 71
Flow Cytometry 408
Hemagglutination Inhibition 136
Luminex xMAP 138
Clinical Assessments:None
SDY420: Immunobiology of Aging
Status: Updated
Description: Overriding aim: To develop and make available to other investigators a comprehensive immune phenotype and functional database of a cohort of at least 700 normal healthy individuals. The dataset will comprise a cross-sectional analysis of the general population between the ages of 40 and 90+ (representing equal gender and representative ethnic population, and equal distribution by decade of life). The registry will contain demographic data, race/ethnicity, prescribed medications, over the counter medications, vitamins, alternative therapies, physical function questionnaire, alternative contact person, and HIPPA release. Fasting blood will be obtained for immune phenotyping and functional analyses. The immune profile will contain the results of both conventional and novel immune profiling assays to profile immune related phenotypic and functional changes associated with aging (using PBMC subset analysis, cytokines, and activation induced signaling of PBMCs for phosphoepitope and gene expression analyses). Data from these analyses will be useful in identifying biomarkers associated with aging, gender and/or chronic infection as well as correlation with phenotypic and functional aspects of aging such as sarcopenia and disability. The immune profile (as well as normal blood chemistries and demographic data) of these subjects will be made available to serve as the basis for future longitudinal study of change in the immune profile over time in association with the development of co-morbidities associated with aging. The primary deliverable for this proposal will be a unique open access electronic data repository that has phenotypic and functional information in multiple scales (epidemiological, and clinical, and, at the cell and molecular level, of immune phenotype) and genetic and proteomic information (gene and protein expression of resting and activated PBCs) on over 700 healthy individuals at different ages from 40 to 90 years. This resource will enable a systems-based approach to the immunology of aging.
Program/Contract:
ProgramContract
NIH American Recovery & Reinvestment Act Immunobiology of Aging
DOI: 10.21430/M3WHM08QLC
Subjects: 753
Study PI, contact:
NameOrganizationSite
Charles Fathman Stanford University Stanford University Schools of Medicine
Publications:
Large-Scale and Comprehensive Immune Profiling and Functional Analysis of Normal Human Aging.. PLoS One. Jul 2015. doi: 10.1371/journal.pone.0133627. eCollection 2015. [Pubmed: 26197454]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 284
DNA microarray 120
Flow Cytometry 1130
Luminex xMAP 1140
Clinical Assessments:
Physical Exam
SDY472: Plasmablast response to inactivated and live attenuated influenza vaccines (TIV3/TIV3 ID) in 2013
Status: Updated
Description: This study will be conducted with up to 40 generally healthy children
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3KHTSSSN7
Subjects: 24
Study PI, contact:
NameOrganizationSite
Harry Greenberg Stanford University Stanford University
Publications:None
Resources:
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT02141581]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 24
Hemagglutination Inhibition 136
Luminex xMAP 46
Clinical Assessments:None
SDY478: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination - 2013
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/M3YEJTSS29
Subjects: 70
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
CyTOF 73
Hemagglutination Inhibition 544
Luminex xMAP 138
Clinical Assessments:None
SDY524: AbATE ITN027AI: Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Status: Updated
Description: Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time of type 1 diabetes diagnosis, 60% to 85% of the diabetic person's beta cells have already been destroyed. However, between 15% and 40% of these cells remain and are able to produce insulin. Treatment that slows the destruction of additional beta cells may be able to decrease a patient's reliance on insulin and improve their quality of life. Anti-CD3 mAb is genetically engineered and directed against the CD3 antigen on T cells; this antibody selectively attacks the immune cells responsible for beta cell destruction. In a small exploratory clinical trial, patients with newly diagnosed type 1 diabetes who received a single, 2-week treatment with anti-CD3 mAb had preserved beta cell function and significantly lower insulin requirements than untreated patients for up to two years after therapy. This study will investigate whether a second course of anti-CD3 mAb administered one year after the first administration is able to prolong or improve the effects of the biologic in people who have recently diagnosed type 1 diabetes mellitus. Participants will be randomly assigned to one of two groups. The Experimental Group will receive anti-CD3 mAb treatment plus Diabetes Standard of Care Treatment; the Active Comparator Group will receive Diabetes Standard of Care Treatment. The Experimental Group will be treated with the antibody for the first 14 days of the study and again one year later. These participants will be admitted to the hospital for the first 5 days of a treatment cycle. Participants who live within 1 hour of the hospital may receive the remainder of a treatment cycle as an outpatient, but those who live farther away will be hospitalized for 14 days. For the first treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 1, 2, 3, 6, 9, and 12. For the second treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 13, 16, 19, 21, and 24.The Active Comparator Group will have 12 study visits over two years. At study entry, all participants will receive daily iron supplementation, either as ferrous sulfate or a multivitamin with iron. Participants will be followed for up to 2 years to assess their overall diabetes health and to capture laboratory measures of beta cell and immune system function. Medication history and adverse event assessment will occur at all visits. A physical exam, vital signs measurement, and blood collection will occur at most visits. Medical history and urine collection will occur at selected visits.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3YQ7O1CPL
Subjects: 83
Study PI, contact:
NameOrganizationSite
Kevan Herold Yale University Yale University
Publications:
Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders.. Diabetes. Nov 2013. doi: 10.2337/db13-0345. Epub 2013 Jul 8. [Pubmed: 23835333]
Partial exhaustion of CD8 T cells and clinical response to teplizumab in new-onset type 1 diabetes.. Sci Immunol. Nov 2016. doi: 10.1126/sciimmunol.aai7793. Epub 2016 Nov 18. [Pubmed: 28664195]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT00129259]
ITNTrialShare.org https://www.itntrialshare.org/project/Studies/ITN027AIPUBLIC/Study%20Data/begin.view]
Assays:None
Clinical Assessments:None
SDY565: IL2-RAPA ITN018AI: Proleukin and Rapamune in Type 1 Diabetes Mellitus
Status: Updated
Description: At the time of diagnosis, type 1 diabetes patients have 15-40 percent of their beta cells may remain active and healthy in the pancreas. This Phase I study for individuals 18-45 years of age and diagnosed with type 1 diabetes in the past 3-48 months will be treated with Proleukin (subcutaneously) 3 times per week for 28 days and Rapamune (orally, daily) for 12 weeks. The trial will test whether the combination of Proleukin and Rapamune can be safely administered and whether treatment halts the autoimmune destruction of remaining beta cells.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3CRD72E92
Subjects: 9
Study PI, contact:
NameOrganizationSite
Carla Greenbaum Benaroya Research Institute Benaroya Research Institute
Publications:
Rapamycin/IL-2 combination therapy in patients with type 1 diabetes augments Tregs yet transiently impairs ?-cell function.. Diabetes. Sep 2012. doi: 10.2337/db12-0049. Epub 2012 Jun 20. [Pubmed: 22721971]
Resources:
Immune Tolerance Network (ITN) Trialshare https://www.itntrialshare.org/project/Studies/ITN018AIPUBLIC/Study%20Data/begin.view]
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00525889]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 211
Clinical Assessments:None
SDY567: Shapiro ITN005CT: Islet Transplantation in Type 1 Diabetic Patients
Status: Updated
Description: The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3V0RG6S52
Subjects: 34
Study PI, contact:
NameOrganizationSite
James Shapiro University of Alberta, Clinical Islet Transplant Program University of Alberta
Publications:
Portal vein thrombosis complicating islet transplantation in a recipient with the Factor V Leiden mutation.. Transplantation. Jul 2004. doi: - [Pubmed: 15257060]
International trial of the Edmonton protocol for islet transplantation.. N Engl J Med. Sep 2006. doi: - [Pubmed: 17005949]
Resources:
Immune Tolerance Network (ITN) Trialshare https://www.itntrialshare.org/project/Studies/ITN005CTPUBLIC/Study%20Data/begin.view?]
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/record/NCT00014911]
Assays:None
Clinical Assessments:None
SDY568: Orban ITN012AI: Evaluation of Diabetes Vaccine IBC-VSO1 in Newly Diagnosed Diabetics
Status: Updated
Description: This study will evaluate whether IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction, protects against autoimmune attack in newly diagnosed type 1 diabetes patients. Halting beta-cell destruction may result in a prolonged remission and subsequent delay in diabetes related complications. Patients in this study must have been diagnosed with type 1 diabetes no more than 3 months prior to study enrollment.
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3IBWCGI97
Subjects: 12
Study PI, contact:
NameOrganizationSite
Tihamer Orban Joslin Diabetes Center Children's Hospital, Joslin Diabetes Center, Boston
Publications:
Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherapy.. J Autoimmun. Jun 2010. doi: 10.1016/j.jaut.2009.10.005. [Pubmed: 19931408]
Resources:
Immune Tolerance Network (ITN) Trialshare https://www.itntrialshare.org/project/Studies/ITN012AIPUBLIC/Study%20Data/begin.view]
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00057499]
Assays:None
Clinical Assessments:None
SDY569: Herold II ITN007AI: Treatment with hOKT3-gamma-1 (Ala-Ala) in Type 1 Diabetes Mellitus
Status: Updated
Description: This open-label phase II trial involving 2 arms where treatment is 0 or 3 cycles of hOKT3gamma1 (Ala-Ala) 6 months apart over the first year of disease in participants with new onset T1DM. Cycles consist of 12 daily doses hOKT3gamma1 (Ala-Ala).
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3WGK6K01J
Subjects: 11
Study PI, contact:
NameOrganizationSite
Kevan Herold Yale University Benaroya Research Institute
Publications:None
Resources:
Immune Tolerance Network (ITN) Trialshare https://www.itntrialshare.org/project/Studies/ITN007AIPUBLIC/Study%20Data/begin.view]
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00806572]
Assays:None
Clinical Assessments:None
SDY720: Age-related alterations in innate immune responses (See companion study SDY739)
Status: Updated
Description: Aging leads to dysregulation of multiple components of the immune system that result in increased susceptibility to infections and poor response to vaccines in the aging population. The dysfunctions of adaptive B and T cells are well documented but the effect of aging on innate immunity remains incompletely understood. Using a heterogeneous population of peripheral blood mononuclear cells (PBMCs), we first undertook transcriptional profiling and found that PBMCs isolated from old individuals (>= 65 yrs) exhibited a delayed and altered response to stimulation with TLR4, TLR7/8, and RIG-I agonists compared to cells obtained from adults (<= 40 yrs). This delayed response to innate immune agonists resulted in the reduced production of pro-inflammatory and antiviral cytokines and chemokines including TNFa, IL-6, IL-1b, IFNg, IFNa, CCL2 and CCL7. While the major monocyte and dendritic cell subsets did not change numerically with aging, activation of specific cell types was altered. PBMCs from old subjects also had a lower frequency of CD40+ monocytes, impaired up-regulation of PD-L1 on monocytes and T cells and increased expression of PD-L2 and B7-H4 on B cells. The defective immune response to innate agonists adversely affected adaptive immunity as TLR-stimulated PBMCs (minus CD3 T cells) from old subjects elicited significantly lower levels of adult T cell proliferation than those from adult subjects in an allogeneic mixed lymphocyte reaction (MLR). Collectively, these age-associated changes in cytokine, chemokine and interferon production, as well as co-stimulatory protein expression could contribute to the blunted memory B and T cell immune responses to vaccines and infections.
Program/Contract:
ProgramContract
Protective Immunity in Special Populations Immunological basis of age-related vulnerability in biodefense and emerging infections SP2 UAz
DOI: 10.21430/M3FZ2BAZSA
Subjects: 61
Study PI, contact:
NameOrganizationSite
Elias Haddad Drexel University College of Medicine Division of Infectious Diseases and HIV Medicine
Publications:
Global analyses revealed age-related alterations in innate immune responses after stimulation of pathogen recognition receptors.. Aging Cell. Jun 2015. doi: 10.1111/acel.12320. Epub 2015 Feb 27. [Pubmed: 25728020]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 192
ELISA 96
Flow Cytometry 408
Luminex xMAP 447
Clinical Assessments:None
SDY756: Histology post influenza
Status: Updated
Description: Histological analysis in lung post infection of B6 or B6 A02 transgenic AAD mice with influenza A/PR8/34 virus
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Crossprotective CTL Against Influenza
DOI: 10.21430/M3EWWO0ERE
Subjects: 1
Study PI, contact:
NameOrganizationSite
Ellis Reinherz Harvard Medical School Dana Farber Cancer Institute
Publications:None
Resources:
Reinherz Lab http://dms.hms.harvard.edu/immunology/fac/Reinherz.php]
Assays:
Assay TypeNumber of Exp. Samples
Microscopy 20
Clinical Assessments:None
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