DR33 DataRelease

SDY787: T cell immune signature of whole cell vs acellular pertussis vaccination in healthy individuals
Status: New
Description: T cell immune signature of whole cell (wP) vs acellular pertussis (aP) vaccination as well as priming in healthy individuals was studied. Healthy adults originally primed with either aP or wP were recruited. A subset of these donors was boosted with aP and subsequently tested 0.5 to 44 months after the boost.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (La Jolla)
DOI: None
Subjects: 144
Study PI, contact:
NameOrganizationSite
Alessandro Sette La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
Th1 versus Th2 T cell polarization by whole-cell and acellular childhood pertussis vaccines persists upon re-immunization in adolescence and adulthood.. Cellular immunology Jun-Jul 2016. doi: 10.1016/j.cellimm.2016.05.002 [Pubmed: 27212461]
Th1/Th17 polarization persists following whole-cell pertussis vaccination despite repeated acellular boosters.. The Journal of clinical investigation Aug 2018. doi: 10.1172/JCI121309 [Pubmed: 29920186]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 74
ELISPOT 139
HLA Typing 87
Luminex xMAP 806
RNA sequencing 64
Clinical Assessments:None
SDY1331: Efficacy of Islet After Kidney Transplantation (CIT-06) 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. Unlike the other studies, subjects in CIT06 had previously received a kidney transplant and were receiving maintenance immunosuppression. CIT06 was a single arm Phase 3 license-supporting study. At the time of islet transplant, subjects in CIT06 received induction therapy in an open-label fashion with rabbit anti-thymocyte globulin (ATG, 5 doses; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) and etanercept. Subjects remained on their calcineurin-based maintenance immunosuppression regimen already in place for their renal allograft.
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 CLINICAL ISLET TRANSPLANTATION: DATA COORDINATING CENTER
The Clinical Islet Transplantation Consortium STRATEGIES TO IMPROVE LONG TERM ISLET GRAFT SURVIVAL
The Clinical Islet Transplantation Consortium INNATE IMMUNITY IN CLINICAL ISLET TRANSPLANTATION
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 IMMUNE TOLERANCE NETWORK
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION: CLINICAL CENTERS
DOI: 10.21430/M33GZ8UR05
Subjects: 24
Study PI, contact:
NameOrganizationSite
James Markmann Massachusetts General Hospital Massachusetts General Hospital
Bernhard Hering University of Minnesota University of Minnesota
Xunrong Luo Northwestern University Northwestern University
Jose Oberholzer University of Illinois University of Illinois
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 b-cell secretory capacity after human islet transplantation according to the CIT07 protocol.. Diabetes Aug 2013. doi: 10.2337/db12-1802 [Pubmed: 23630300]
Improvement in insulin sensitivity after human islet transplantation for type 1 diabetes.. The Journal of clinical endocrinology and metabolism Nov 2013. doi: 10.1210/jc.2013-1764 [Pubmed: 24085506]
Insulin sensitivity index in type 1 diabetes and following human islet transplantation: comparison of the minimal model to euglycemic clamp measures.. American journal of physiology. Endocrinology and metabolism May 2014. doi: 10.1152/ajpendo.00667.2013 [Pubmed: 24691031]
Restoration of Glucose Counterregulation by Islet Transplantation in Long-standing Type 1 Diabetes.. Diabetes May 2015. doi: 10.2337/db14-1620 [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 technology & therapeutics Apr 2015. doi: 10.1089/dia.2014.0289 [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 [Pubmed: 27208344]
Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation.. Diabetes Sep 2016. doi: 10.2337/db16-0222 [Pubmed: 27325286]
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: 10.2337/db16-0234 [Pubmed: 27465220]
Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes.. The Journal of clinical endocrinology and metabolism Nov 2016. doi: 10.1210/jc.2016-1649 [Pubmed: 27571180]
Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue.. The Journal of clinical investigation Apr 2017. doi: 10.1172/JCI87993 [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 [Pubmed: 29563196]
Resources:
CIT-06 ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00468117]
NIDDK Repository https://repository.niddk.nih.gov/studies/cit-06/]
CIT-08 ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01369082]
Clinical Islet Transplantation Consortium https://www.citisletstudy.org/]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 37
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1335: Immune Profiling Assay Development for Pertussis vaccines
Status: New
Description: Enrollment min/max Age Unit is years old
Program/Contract:
ProgramContract
Respiratory Pathogens Research Center (RPRC) Respiratory Pathogens Research Center (RPRC)
DOI: 10.21430/M3T5G6GG5X
Subjects: 72
Study PI, contact:
NameOrganizationSite
Sally Quataert University of Rochester Medical Center University of Rochester
Publications:None
Resources:
Respiratory Pathogen Research Center Studies https://www.urmc.rochester.edu/respiratory-pathogens-research-center/projects.aspx]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 1558
Clinical Assessments:None
SDY1402: PROGENI-KI (CTOT-08)
Status: New
Description: Kidney transplantation is a good 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 working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers). This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).
Program/Contract:
ProgramContract
Clinical Trials in Organ Transplantation (CTOT) Proteogenomics for Organ Transplantation: Prediction, Diagnosis, Intervention
DOI: 10.21430/M3Z4SLIS4Q
Subjects: 307
Study PI, contact:
NameOrganizationSite
Michael Abecassis Feinberg School of Medicine, Northwestern University Feinberg School of Medicine, Northwestern University
Publications:
Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant.. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons Jan 2019. doi: 10.1111/ajt.15011 [Pubmed: 29985559]
Gene expression biomarkers for kidney transplant rejection - The entire landscape.. EBioMedicine Apr 2019. doi: 10.1016/j.ebiom.2019.03.060 [Pubmed: 30910482]
Gene expression biomarkers for kidney transplant rejection-The entire landscape-Author's reply.. EBioMedicine Apr 2019. doi: 10.1016/j.ebiom.2019.03.061 [Pubmed: 30930045]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01289717]
NCBI GEO GSE107509 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE107509]
Assays:
Assay TypeNumber of Exp. Samples
Array 530
Clinical Assessments:None
SDY1466: Monozygotic and Dizygotic Twin Pair T-Cell Responses to Influenza Vaccination SLVP018 2013
Status: New
Description: Evaluate the variation in immune response between individuals and assess whether it changes as a function of age and similarity in genetic and environmental background (by comparing differences between monozygotic and dizygotic twin pairs of different ages).
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33B64BQUE
Subjects: 20
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
Variation in the human immune system is largely driven by non-heritable influences.. Cell Jan 2015. doi: 10.1016/j.cell.2014.12.020 [Pubmed: 25594173]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01987349]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 160
Clinical Assessments:None
SDY1468: B-cell Immunity to Influenza (SLVP017) 2010
Status: New
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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M30IB1ZZDJ
Subjects: 70
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03020498]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 420
Luminex xMAP 390
Clinical Assessments:None
SDY1469: B-cell Immunity to Influenza (SLVP017) 2011
Status: New
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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3HXQPVM9E
Subjects: 21
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03020498]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 171
Luminex xMAP 112
Clinical Assessments:None
SDY1471: B-cell Immunity to Influenza (SLVP017) 2013
Status: New
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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3WEPI1HA3
Subjects: 8
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03020537]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 56
Clinical Assessments:None
SDY1475: Expanded PD-1hi CXCR5- T peripheral helper cells promote B cells responses in lupus via IL-21
Status: New
Description: Evaluate the T cell populations altered in the circulation of patients with SLE by highdimensionalmass cytometry. We identify a highly expanded population of PD-1hi CXCR5- Tcells in SLE patients, including in early SLE patients studied prior to initiation of strongimmunosuppressive therapies. By phenotype, transcriptome, and function, these cells are Tphcells, a peripherally homing B cell helper population
Program/Contract:
ProgramContract
NIH Program Molecular Control of Cd4 T Cell Ability To Help B Cells
DOI: 10.21430/M32K1Q3IAP
Subjects: 64
Study PI, contact:
NameOrganizationSite
Deepak Rao Brigham and Women's Hospital Brigham and Women's Hospital
Publications:
PD-1hiCXCR5- T peripheral helper cells promote B cell responses in lupus via MAF and IL-21.. JCI insight Oct 2019. doi: 10.1172/jci.insight.130062 [Pubmed: 31536480]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 124
Clinical Assessments:
History of nephritis (yes/no)
SLEDAI-2k
SDY1513: Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults (CoFAR1)
Status: New
Description: This Phase 1 multi-center, non-randomized, open label safety trial will investigate the safety of EMP-123, a rectally administered vaccine consisting of three recombinant modified peanut antigens encapsulated within dead E. coli. EMP-123 will be administered to healthy volunteers for 4 weekly administrations of the study product in a dose escalation manner followed by 4 weeks of follow-up, then a Data Safety Monitoring Board (DSMB) review. If no safety concerns are noted, 10 peanut allergic subjects will be enrolled with weekly dose escalation of the study product for 10 weeks followed by biweekly treatment at a fixed dose (same dose as 10th dose) for 6 weeks. These subjects will then return in 4 weeks for a final assessment. If a delay in dose escalation is required (as defined in Section 6.6), the dose may be escalated during the biweekly dosing interval. Only a single repeat dose or dose reduction will be permitted in this trial. Dosing will not be continued beyond 13 doses or 16 weeks, and the dose will not be escalated beyond 3,063 ug (total modified peanut protein with no adjustment for body weight).
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M3UEJMBVUI
Subjects: 28
Study PI, contact:
NameOrganizationSite
Scott Sicherer Mount Sinai School of Medicine Mount Sinai School of Medicine
Publications:
A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy.. Allergy Jun 2013. doi: 10.1111/all.12158 [Pubmed: 23621498]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00850668]
Assays:None
Clinical Assessments:None
SDY1514: An Observational Study of Childhood Food Allergy (CoFAR2)
Status: New
Description: This observational study will investigate the developmental immunology of peanut, egg, and milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut allergy. This strategy will help to delineate, compare, and contrast biological markers and immunologic changes associated with the development of peanut allergy and loss of egg and milk allergy, while simultaneously evaluating important clinical and environmental influences likely to account for the recent rise in the prevalence of these allergies. The hallmark of food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies that represent an end result of a T helper 2 (Th2) influenced immune response. Currently, there is only a limited understanding of the mechanisms involved in the developmental course of food allergies. To effectively prevent or reverse the progression of food allergy, immune interventions will be needed. Furthermore, it is likely that successful strategies will need to be directed to those persons at identifiable risk (e.g., who have biomarkers associated with development of peanut allergy).
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M3CCG5XNFF
Subjects: 515
Study PI, contact:
NameOrganizationSite
Scott Sicherer Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Publications:
Immunologic features of infants with milk or egg allergy enrolled in an observational study (Consortium of Food Allergy Research) of food allergy.. The Journal of allergy and clinical immunology May 2010. doi: 10.1016/j.jaci.2010.02.038 [Pubmed: 20451041]
The natural history of egg allergy in an observational cohort.. The Journal of allergy and clinical immunology Feb 2014. doi: 10.1016/j.jaci.2013.12.1041 [Pubmed: 24636473]
Atopic dermatitis increases the effect of exposure to peanut antigen in dust on peanut sensitization and likely peanut allergy.. The Journal of allergy and clinical immunology Jan 2015. doi: 10.1016/j.jaci.2014.10.007 [Pubmed: 25457149]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00356174]
Assays:None
Clinical Assessments:None
SDY1515: Peanut Sublingual Immunotherapy (CoFAR4)
Status: New
Description: Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine in the event of peanut exposure. The sublingual route is a potential method to administer immunotherapy for the treatment of food allergies. The intent of this study is to induce desensitization and eventually tolerance to peanut protein and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for individuals with peanut allergy. The trial will enroll 40 participants. After the first 10 participants between the ages of 18 and 40 are enrolled, safety information will be reviewed. If there are no safety concerns, the study will continue to enroll the remaining participants between the ages of 12 and 40. This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge (OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and maintenance therapy over a 44-week period, followed by another OFC. Following the OFC, participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a higher maximum dose than the first treatment group. Maintenance therapy will continue for both groups for more than 2 years. Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant throughout the course of the study. Additionally, 10 participants will be enrolled as control participants who will not receive any study therapy and will only have blood drawn at 3 visits throughout the course of the trial.
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M3UH9QGIY2
Subjects: 62
Study PI, contact:
NameOrganizationSite
Hugh Sampson Mount Sinai School of Medicine Mount Sinai School of Medicine
Publications:
Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial.. The Journal of allergy and clinical immunology Jan 2013. doi: 10.1016/j.jaci.2012.11.011 [Pubmed: 23265698]
Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.. The Journal of allergy and clinical immunology May 2015. doi: 10.1016/j.jaci.2014.12.1917 [Pubmed: 25656999]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00580606]
Assays:None
Clinical Assessments:None
SDY1519: Eosinophilic Esophagitis Databank (CoFAR5)
Status: New
Description: This is a multi-site, single visit registry in subjects aged 6 months to 65 years old, of any race, gender, or ethnicity with a biopsy confirmed EoE. Participants/parents/guardians will provide responses regarding the medical history, and will provide salivary and/or blood samples. The study team will have access to the participant's medical record to verify diagnosis information and medical history.
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M36BWCCNH7
Subjects: 709
Study PI, contact:
NameOrganizationSite
Mirna Chehade Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai
Marc Rothenberg Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center
Publications:
Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease.. Nature genetics Aug 2014. doi: 10.1038/ng.3033 [Pubmed: 25017104]
Phenotypic Characterization of Eosinophilic Esophagitis in a Large Multicenter Patient Population from the Consortium for Food Allergy Research.. The journal of allergy and clinical immunology. In practice Sep 2018. doi: 10.1016/j.jaip.2018.05.038 [Pubmed: 30075341]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01323803]
Assays:None
Clinical Assessments:None
SDY1520: Peanut Epicutaneous Immunotherapy (CoFAR6)
Status: New
Description: This is a multi-center, randomized, double-blind, placebo-controlled trial of DBV712 (Viaskin Peanut) in peanut-allergic subjects reacting to <1044 mg of peanut protein in an OFC. Subjects will be randomized to two doses of Viaskin Peanut patch or matched placebo (1:1:1) and then will undergo a 5044 mg of peanut protein OFC at week 52, designed to investigate the efficacy, safety and immunologic effects of Viaskin Peanut patch treatment for peanut allergy. Active Viaskin Peanut patch dosing will be with 100 ?g and 250 ?g patches applied every 24 hours and Viaskin placebo patch dosing will be with a placebo (no antigen) patch applied every 24 hrs. At 52 weeks, a 5044 mg of peanut protein OFC will occur. After the 52-week OFC the subject will be unblinded. In the unlikely event that an active subject on active treatment passes the week 52 OFC and has a peanut-specific IgE<2 kUA/L, he/she will discontinue dosing for up to 20 weeks. Sustained unresponsiveness (defined in Section 1.1) will be assessed with a 5044 mg of peanut protein OFCs, followed by an open feeding at 8 weeks, and if negative, again at 20 weeks. Those who pass the OFC after 20 weeks off treatment will be instructed to add peanut to their diet. Those that fail either of these OFCs will resume dosing as described in section 3. Subjects who fail the week 52 OFC, either active or placebo will dose with the 250 ?g dose from the time of unblinding (~ week 52) through week 130. After the 52-week OFC, placebo-treated subjects who do not demonstrate sustained unresponsiveness, will cross-over to active treatment at a dose of 250 ?g daily for a total of 30 months (130 weeks) of active therapy. At the end of study, all subjects will undergo a 5044 mg of peanut protein OFC on treatment; those who pass the OFC will have treatment discontinued and will have an OFC at 8 weeks and 20 weeks, to assess for sustained unresponsiveness off of therapy. Throughout the protocol, all subjects will remain on a peanut-free diet for the duration of active therapy and through any challenges after therapy is completed.
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M397ZURMSI
Subjects: 86
Study PI, contact:
NameOrganizationSite
Stacie Jones University of Arkansas for Medical Sciences University of Arkansas for Medical Sciences
Publications:
Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.. The Journal of allergy and clinical immunology Apr 2017. doi: 10.1016/j.jaci.2016.08.017 [Pubmed: 28091362]
Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets.. The Journal of allergy and clinical immunology Jun 2018. doi: 10.1016/j.jaci.2017.11.060 [Pubmed: 29408715]
Resources:
ClinicalTrial.gov https://clinicaltrials.gov/ct2/show/NCT01904604]
Assays:None
Clinical Assessments:None
SDY1533: Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes (CIT-03) 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. The focus of CIT03 was to evaluate the investigational agent, deoxyspergualin. Subjects in CIT03 received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), deoxyspergualin, etanercept, sirolimus, and low-dose tacrolimus in an open-label fashion.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium CLINICAL REFINEMENT OF ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION AT NORTHWESTERN
DOI: 10.21430/M3Z6I3UMVL
Subjects: 14
Study PI, contact:
NameOrganizationSite
Publications:None
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00434850]
Assays:None
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1535: TIGIT is upregulated by HIV-1 infection and marks a highly functional adaptive and mature subset of natural killer cells
Status: New
Description: Performed a mass cytometry-based screen of NK cell receptor expression patterns in healthy controls and HIV+ individuals and then focused mechanistic studies on the expression and function of T cell immunoreceptor with Ig and ITIM domains (TIGIT)
Program/Contract:
ProgramContract
NIH Program Natural Killer Cell Repertoire In Hiv Infection Outcomes
DOI: 10.21430/M368XIMING
Subjects: 50
Study PI, contact:
NameOrganizationSite
Catherine Blish Stanford University Stanford University
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 100
Clinical Assessments:None
SDY1544: LEA29Y (Belatacept) Emory Edmonton Protocol (LEEP) (CIT-04) 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. The focus of CIT04 was to evaluate the effectiveness of an IS regimen that included belatacept. For immunosuppression, CIT04 subjects received belatacept, basiliximab, and mycophenolate mofetil in an open-label fashion.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium CLINICAL REFINEMENT OF ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION AT NORTHWESTERN
DOI: 10.21430/M3F5QE35RO
Subjects: 10
Study PI, contact:
NameOrganizationSite
James Shapiro University of Alberta University of Alberta
Nicole Turgeon Emory University Emory University
Publications:None
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00468403]
Assays:None
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1550: Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7)
Status: New
Description: This is a multi-center, randomized, open label study to investigate sustained unresponsiveness induction and safety of Baked Egg vs. Egg OIT, for OFC documented egg allergy, in individuals who pass a 2 gm baked egg protein OFC. All eligible subjects will receive a double-blind placebo controlled baked egg OFC. Individuals who pass the baked egg OFC will then have a double-blind placebo controlled egg OFC. Those who react at a cumulative dose of <= 1444 mg of egg white protein will be randomized 1:1 to Baked Egg or Egg OIT. Approximately 40 of the first individuals who do not pass the initial baked egg food challenge will be assigned to Egg OIT and are the Egg OIT assignment group. Those who tolerate more than 1444 mg of egg white protein on the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1 year and a 2 year OFC.
Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M3UFZVM91I
Subjects: 187
Study PI, contact:
NameOrganizationSite
Hugh Sampson Mount Sinai School of Medicine Mount Sinai School of Medicine
Publications:
Transcriptional Profiling of Egg Allergy and Relationship to Disease Phenotype.. PloS one Oct 2016. doi: 10.1371/journal.pone.0163831 [Pubmed: 27788149]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01846208]
Assays:None
Clinical Assessments:None
SDY1553: Strategies to Improve Long Term Islet Graft Survival (CIT-02) 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. The CIT02 protocol focused on treating islets pre-transplant, and subjects were randomized to receive islets prepared with either Lisofylline or Exenatide. For induction and maintenance immunosuppression, the subjects received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus in an open-label fashion.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium CLINICAL REFINEMENT OF ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION AT NORTHWESTERN
DOI: 10.21430/M3VGVKPRV0
Subjects: 6
Study PI, contact:
NameOrganizationSite
Ali Naji University of Pennsylvania University of Pennsylvania
Camillo Ricordi University of Miami University of Miami
Publications:None
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00464555]
Assays:None
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1554: B-Lymphocyte Immunotherapy in Islet Transplantation (CIT-05) 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 CIT05 received, in an open label-fashion, the anti-CD20 agent rituximab in combination with rabbit anti-thymocyte globulin (ATG; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) for induction and sirolimus alone for maintenance, a calcineurin-inhibitor free regimen.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium CLINICAL REFINEMENT OF ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium CLINICAL ISLET TRANSPLANTATION AT NORTHWESTERN
DOI: 10.21430/M38DLILKD5
Subjects: 2
Study PI, contact:
NameOrganizationSite
Ali Naji University of Pennsylvania University of Pennsylvania
Publications:None
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00468442]
Assays:None
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1594: Modified CyTOF Helios Injector Can Improve Data Quality
Status: New
Description: Healthy donor PBMCs were collected, CD45 barcoded, pooled and stained with a standard immunophentyping panel. The stained and fixed cells were then divided into multiple aliquots, frozen and distributed to 7 institutions and acquired on 10 separate Helios mass cytometers using both the standard and modified acqusition protocols to evaluate staining quality and inter-instrument variability
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Dengue Human Immunology Project Consortium (DHIPC MSSM)
DOI: 10.21430/M3O1ZSRR7P
Subjects: 5
Study PI, contact:
NameOrganizationSite
Adeeb Rahman Icahn School of Medicine at Mt. Sinai Department of Genetics and Genomic Sciences
Publications:
A Modified Injector and Sample Acquisition Protocol Can Improve Data Quality and Reduce Inter-Instrument Variability of the Helios Mass Cytometer.. Cytometry. Part A : the journal of the International Society for Analytical Cytology Sep 2019. doi: 10.1002/cyto.a.23866 [Pubmed: 31364278]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 100
Clinical Assessments:None
SDY1598: Epidemiological Evidence for Lineage-Specific Differences in the Risk of Inapparent Chikungunya Virus Infection
Status: New
Description: Estimate the ratio of symptomatic to asymptomatic CHIKV infections (S:A ratio), elucidate sign and symptom cooccurrence, characterize the probability of infection and disease occurrence across age, identify risk factors associated with infection and disease outcomes, and quantify differences in the proportions of inapparent CHIKV infections between the Asian CHIKV lineage and the ECSA CHIKV lineage
Program/Contract:
ProgramContract
Protective Immunity Following Dengue Virus Natural Infections and Vaccination Protective Immunity Following Dengue Virus Natural Infections and Vaccination
DOI: 10.21430/M3IANCCO4A
Subjects: 296
Study PI, contact:
NameOrganizationSite
Eva Harris University of California, Berkeley Managua, Nicaragua
Publications:
Epidemiological Evidence for Lineage-Specific Differences in the Risk of Inapparent Chikungunya Virus Infection.. Journal of virology Feb 2019. doi: 10.1128/JVI.01622-18 [Pubmed: 30463967]
Resources:
Journal of Virology https://jvi.asm.org/content/93/4/e01622-18]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 592
Clinical Assessments:None
SDY25: Genotyping and gene function in healthy volunteers
Status: Updated
Description:

The goal of this study is to create a pool of potential subjects genotyped in a manner identical to that used in the AVA000 trial population.

Subjects were screened for exclusion based on history of chronic infectious or immune diseases and to avoid sampling during current acute infection. Genotyping data are available for reference purposes. The subjects agreed to be available to be recalled for sampling of blood for ex vivo studies of differential immunologic function of genetic variants corresponding to those associated with variation in vaccine response.

Program/Contract:
ProgramContract
Population Genetics Analysis Program (1) Population Genetics Analysis Program: Immunity to Vaccines/Infections
DOI: 10.21430/M3L5GO913J
Subjects: 1426
Study PI, contact:
NameOrganizationSite
Richard Kaslow University of Alabama at Birmingham "University of Alabama, Birmingham"
Publications:
The role of HLA-DR-DQ haplotypes in variable antibody responses to anthrax vaccine adsorbed.. Genes and immunity Sep 2011. doi: 10.1038/gene.2011.15 [Pubmed: 21368772]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 379
Other 1
PCR 1
SNP microarray 1
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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 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
Flow Cytometry 2208
Hemagglutination Inhibition 66
Luminex xMAP 229
Nanostring 18
Neutralizing Antibody Titer Assay 27
Transcription profiling by array 703
Virus Neutralization 89
Clinical Assessments:None
SDY211: Inner-City Anti-IgE Therapy for Asthma (ICATA/ICAC-08)
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) RFA-AI-13-036 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.. The New England journal of medicine Mar 2011. doi: 10.1056/NEJMoa1009705 [Pubmed: 21410369]
A computerized decision support tool to implement asthma guidelines for children and adolescents.. The Journal of allergy and clinical immunology May 2019. doi: 10.1016/j.jaci.2018.10.060 [Pubmed: 30529451]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct/show/NCT00377572]
Assays:None
Clinical Assessments:None
SDY218: Oral Immunotherapy for Childhood Egg Allergy (CoFAR3)
Status: Updated
Description:

In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time. This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC).

For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg.

Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg.

At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Program/Contract:
ProgramContract
Immunobiology of Food Allergy and Its Treatment Immunobiology of Food Allergy and Its Treatment (CoFAR)
DOI: 10.21430/M3Q2O0X9Z5
Subjects: 55
Study PI, contact:
NameOrganizationSite
Wesley Burks Duke University Multiple sites
Stacie Jones Arkansas Children's Hospital Multiple sites
Publications:
Oral immunotherapy for treatment of egg allergy in children.. The New England journal of medicine Jul 2012. doi: 10.1056/NEJMoa1200435 [Pubmed: 22808958]
Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy.. The Journal of allergy and clinical immunology Apr 2016. doi: 10.1016/j.jaci.2015.12.1316 [Pubmed: 26924470]
Component-resolved analysis of IgA, IgE, and IgG4 during egg OIT identifies markers associated with sustained unresponsiveness.. Allergy Nov 2016. doi: 10.1111/all.12895 [Pubmed: 27015954]
A 5-year Summary of Real-life Dietary Egg Consumption after Completion of a 4-year Egg OIT Protocol.. The Journal of allergy and clinical immunology Dec 2019. doi: 10.1016/j.jaci.2019.11.045 [Pubmed: 31881232]
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT00461097?term=NCT00461097]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 939
Flow Cytometry 2370
Clinical Assessments:None
SDY311: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) SLVP015 2010 (See companion studies SDY315 2012 / 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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33MSDRJ55
Subjects: 76
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford-LPCH Vaccine Program
Publications:
A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.. Nature medicine Mar 2019. doi: 10.1038/s41591-019-0381-y [Pubmed: 30842675]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 79
Flow Cytometry 464
Hemagglutination Inhibition 140
Luminex xMAP 426
Transcription profiling by array 73
Clinical Assessments:None
SDY315: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) SLVP015 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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 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:
A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.. Nature medicine Mar 2019. doi: 10.1038/s41591-019-0381-y [Pubmed: 30842675]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 74
Flow Cytometry 408
Hemagglutination Inhibition 136
Luminex xMAP 138
Transcription profiling by array 71
Clinical Assessments:None
SDY400: Immunologic and genomic signatures of influenza vaccine response - 2012 (see companion studies SDY63, SDY404, SDY520)
Status: Updated
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year3 2012
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 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
Mass Spectrometry 118
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: Updated
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year2 2011
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 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.. The Journal of infectious diseases Apr 2015. doi: 10.1093/infdis/jiu573 [Pubmed: 25367297]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 2062
Hemagglutination Inhibition 138
Mass Spectrometry 1086
Transcription profiling by array 512
Clinical Assessments:None
SDY478: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 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:
A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.. Nature medicine Mar 2019. doi: 10.1038/s41591-019-0381-y [Pubmed: 30842675]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
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
SDY520: Immunologic and genomic signatures of influenza vaccine response - 2013 (see companion studies SDY63, SDY404, SDY400)
Status: Updated
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year4 2013
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Defining signatures for immune responsiveness by functional systems immunology HIPC1
DOI: 10.21430/M3KVVHM735
Subjects: 61
Study PI, contact:
NameOrganizationSite
David Hafler Yale Yale
Publications:None
Resources:
NA NA]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 114
Transcription profiling by array 99
Clinical Assessments:None
SDY619: ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04)
Status: Updated
Description: Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections. The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections. The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin.
Program/Contract:
ProgramContract
Atopic Dermatitis Research Network (ADRN) 2011-2015 Atopic Dermatitis Research Network (ADRN)
DOI: 10.21430/M384Z5ZXPI
Subjects: 150
Study PI, contact:
NameOrganizationSite
Lisa Beck University of Rochester Medical Center University of Rochester Medical Center
Publications:
Temporal and Racial Differences Associated with Atopic Dermatitis Staphylococcusaureus and Encoded Virulence Factors.. mSphere Nov-Dec 2016. doi: 10.1128/mSphere.00295-16 [Pubmed: 27981233]
Altered composition of epidermal lipids correlates with Staphylococcus aureus colonization status in atopic dermatitis.. The British journal of dermatology Oct 2017. doi: 10.1111/bjd.15409 [Pubmed: 28244066]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02115399]
Assays:None
Clinical Assessments:
Dermatology Life Quality Index
EASI Score
SDY640: Immunologic and genomic signatures of influenza vaccine response - 2014
Status: Updated
Description: Project 1: Immunologic and genomic signatures of influenza vaccine response - year5 2014
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Defining signatures for immune responsiveness by functional systems immunology HIPC1
DOI: 10.21430/M3A6GYD5L0
Subjects: 37
Study PI, contact:
NameOrganizationSite
David Hafler Yale Yale
Publications:None
Resources:
LN1 NA]
Assays:
Assay TypeNumber of Exp. Samples
Array 79
Hemagglutination Inhibition 280
Clinical Assessments:None
SDY887: Defective signaling in aging, influenza vaccination 2007 SLVP015
Status: Updated
Description: Pilot year. Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 10 young (20-30 years) and 19 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33JMYFLF1
Subjects: 29
Study PI, contact:
NameOrganizationSite
Cornelia Dekker Stanford University Stanford University
Publications:
Defective Signaling in the JAK-STAT Pathway Tracks with Chronic Inflammation and Cardiovascular Risk in Aging Humans.. Cell systems Oct 2016. doi: 10.1016/j.cels.2016.09.009 [Pubmed: 27746093]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
Department of Pediatrics- Infectious Diseases Stanford University School of Medicine http://med.stanford.edu/pedsid/contact.html]
Shen-Orr Lab, Technion http://shenorrlab.technion.ac.il/]
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 382
Neutralizing Antibody Titer Assay 174
Clinical Assessments:None
SDY997: AMP Lupus Network Project: Molecular Characterization of Lupus Nephritis and Correlation with Response to Therapy
Status: Updated
Description: Phase I will be devoted to the study of at least 45 subjects with lupus nephritis and 25 controls with the intent of achieving the following goals: (i) to assess feasibility of obtaining a sufficient yield of high quality data based on current and refined AMP SOPs, (ii) to assess recruitment rates and the number of sites necessary to effectively recruit for Phase II, (iii) to ensure that the technologies developed in Phase 0 are working well, especially with regard to transport and scaling up to handle specimens from multiple sites; (iv) to demonstrate that the selected technologies can be used for the purpose of reliably differentiating lupus nephritis kidneys from kidney tissue without lupus nephritis, (v) where necessary, to further refine the technologies before embarking on a large-scale project; and most importantly (vi) to provide critical data upon which to make rational decisions about key elements of the Phase II study design (e.g., eligibility criteria, estimates of variation for power calculations, and site-specific capability regarding patient recruitment, specimen handling, etc.).
Program/Contract:
ProgramContract
Accelerating Medicines Partnership RA/SLE (AMP RA/SLE) RFA-AR-14-016 Accelerating Medicines Partnership RA/SLE (AMP RA/SLE)
DOI: 10.21430/M35FLWNXH1
Subjects: 107
Study PI, contact:
NameOrganizationSite
PJ Utz Stanford PEARL
Michael Holers Colorado PEARL
Publications:
Tubular cell and keratinocyte single-cell transcriptomics applied to lupus nephritis reveal type I IFN and fibrosis relevant pathways.. Nature immunology Jul 2019. doi: 10.1038/s41590-019-0386-1 [Pubmed: 31110316]
The immune cell landscape in kidneys of patients with lupus nephritis.. Nature immunology Jul 2019. doi: 10.1038/s41590-019-0398-x [Pubmed: 31209404]
PD-1hiCXCR5- T peripheral helper cells promote B cell responses in lupus via MAF and IL-21.. JCI insight Oct 2019. doi: 10.1172/jci.insight.130062 [Pubmed: 31536480]
The Accelerating Medicines Partnership ? Organizational Structure and Preliminary Data from the Phase 1 Studies of Lupus Nephritis. Arthritis Care & Research September 2019. doi: 10.1002/acr.24066 [Pubmed: Arthritis Care]
A protocol for single-cell transcriptomics from cryopreserved renal tissue and urine for the Accelerating Medicine Partnership (AMP) RA/SLE network. bioRxiv March 2018. doi: 10.1101/275859 [Pubmed: bioRxiv]
Resources:
NIH AMP RA/SLE Program https://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp]
dbGAP Accelerating Medicines Partnership-Rheumatoid Arthritis (AMP-RA) https://www.ncbi.nlm.nih.gov/gap/?term=phs001457.v1.p1]
?Accelerating Medicines Partnership (AMP)?SLE Phase I project https://immunogenomics.io/ampsle]
?Accelerating Medicines Partnership (AMP)?Lupus Nephritis (SLE) Phase I project https://immunogenomics.io/cellbrowser/]
AMP Phase 1 Single Cell Portal https://portals.broadinstitute.org/single_cell/study/amp-phase-1]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 259
Flow Cytometry 171
RNA sequencing 13417
Clinical Assessments:
SLE Assessments
SDY998: AMP Rheumatoid Arthritis Phase 1
Status: Updated
Description: The primary goal for RA arthroplasty P1 studies are: To establish if molecular signatures and pathways identified using core AMP technologies differ between OA and RA in 20 RA surgical samples and 10 OA arthroplasty samples.
Program/Contract:
ProgramContract
Accelerating Medicines Partnership RA/SLE (AMP RA/SLE) RFA-AR-14-016 Accelerating Medicines Partnership RA/SLE (AMP RA/SLE)
DOI: 10.21430/M3KXJHSP4T
Subjects: 62
Study PI, contact:
NameOrganizationSite
Jennifer Anolik Rochester Rochester
Vivian Bykerk HSS HSS
Larry Moreland Pittsburg Pittsburg
Michael Holers Colorado Colorado
Peter Gregersen Northwell Northwell
Gary Firestein UCSD UCSD
PJ Utz Stanford Stanford
Michael Weisman Cedars Sinai Cedars Sinai
Publications:
Methods for high-dimensional analysis of cells dissociated from cryopreserved synovial tissue. Arthritis research & therapy Jul 2018. doi: 10.1186/s13075-018-1631-y [Pubmed: 29996944]
Defining inflammatory cell states in rheumatoid arthritis joint synovial tissues by integrating single-cell transcriptomics and mass cytometry.. Nature immunology Jul 2019. doi: 10.1038/s41590-019-0378-1 [Pubmed: 31061532]
PD-1hiCXCR5- T peripheral helper cells promote B cell responses in lupus via MAF and IL-21.. JCI insight Oct 2019. doi: 10.1172/jci.insight.130062 [Pubmed: 31536480]
HBEGF+ macrophages identified in rheumatoid arthritis promote joint tissue invasiveness and are reshaped differentially by medications. bioRxiv January 2019. doi: 10.1101/525758 [Pubmed: bioRxiv]
Resources:
NIH AMP RA/SLE Program https://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp]
AMP RA ImmunoGenomics Analysis Code https://immunogenomics.io/ampra/]
dbGAP Accelerating Medicines Partnership-Rheumatoid Arthritis (AMP-RA) https://www.ncbi.nlm.nih.gov/gap/?term=phs001457.v1.p1]
?Accelerating Medicines Partnership (AMP)?SLE Phase I project https://immunogenomics.io/ampsle]
?Accelerating Medicines Partnership (AMP)?Lupus Nephritis (SLE) Phase I project https://immunogenomics.io/cellbrowser/]
AMP Phase 1 Single Cell Portal https://portals.broadinstitute.org/single_cell/study/amp-phase-1]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 175
Flow Cytometry 309
Microscopy 421
RNA sequencing 10189
Clinical Assessments:
Medical History
SDY1039: Scleroderma: Cyclophosphamide or Transplantation (SCOT)
Status: Updated
Description: This prospective, randomized, open-label, multi-center, 2-arm, Phase II clinical trial will randomize approximately 114 subjects with severe SSc in the United States and Canada. Subjects will be randomly assigned in a 1:1 ratio to a treatment of high-dose immunosuppressive therapy with autologous stem cell rescue (HDIT transplantation) or to treatment of monthly pulse IV cyclophosphamide. Subjects will be stratified by treatment center. The initial treatment period will be approximately 3 months for the HDIT transplantation arm (from the time of initiation of mobilization until the day of transplant) and 12 months for the cyclophosphamide arm. Subjects will be followed for up to 72 months after randomization. The study will continue for 54 months after the last subject is randomized.
Program/Contract:
ProgramContract
Autoimmunity Centers of Excellence (ACE) AI-12-060, AI-12-059 SCLERODERMA CYCLOPHOSPHAMIDE OR TRANSPLANTION STUDY (SCOT)
DOI: 10.21430/M3SM4YLTLH
Subjects: 141
Study PI, contact:
NameOrganizationSite
Publications:
Gastric antral vascular ectasia and its clinical correlates in patients with early diffuse systemic sclerosis in the SCOT trial.. The Journal of rheumatology Apr 2013. doi: 10.3899/jrheum.121087 [Pubmed: 23418384]
Review: Hematopoietic Stem Cell Transplantation for Scleroderma: Effective Immunomodulatory Therapy for Patients With Pulmonary Involvement.. Arthritis & rheumatology (Hoboken, N.J.) Oct 2016. doi: 10.1002/art.39748 [Pubmed: 27213276]
Myeloablative Autologous Stem-Cell Transplantation for Severe Scleroderma.. The New England journal of medicine Jan 2018. doi: 10.1056/nejmoa1703327 [Pubmed: 29298160]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00114530]
NCBI GEO GSE137276 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE137276]
Assays:
Assay TypeNumber of Exp. Samples
Array 143
Clinical Assessments:
Modified Rodnan Skin Score
Pulmonary Function Tests
Scleroderma Health Assessment Questionnaire
SDY1299: Identification of Three Rheumatoid Arthritis Disease Subtypes By Machine Learning Integration of Synovial Histologic Features and RNA Sequencing Data
Status: Updated
Description: Gene expression analysis of RA and OA synovial tissue revealed 3 distinct synovial subtypes. These labels were used to generate a histologic scoring algorithm in which the histologic scores were found to be associated with parameters of systemic inflammation, including the erythrocyte sedimentation rate, CRP levels, and autoantibody levels. Comparison of gene expression patterns to clinical features revealed a potentially clinically important distinction: mechanisms of pain may differ in patients with different synovial subtypes.
Program/Contract:
ProgramContract
Accelerating Medicines Partnership RA/SLE (AMP RA/SLE) RFA-AR-14-016 Accelerating Medicines Partnership RA/SLE (AMP RA/SLE)
DOI: 10.21430/M3V2G6PBYS
Subjects: 45
Study PI, contact:
NameOrganizationSite
Laura Donlin Hospital for Special Surgery, The Rockefeller University Hospital for Special Surgery
Publications:
Identification of Three Rheumatoid Arthritis Disease Subtypes by Machine Learning Integration of Synovial Histologic Features and RNA Sequencing Data.. Arthritis & rheumatology (Hoboken, N.J.) May 2018. doi: 10.1002/art.40428 [Pubmed: 29468833]
Histologic and Transcriptional Evidence of Subclinical Synovial Inflammation in Patients With Rheumatoid Arthritis in Clinical Remission.. Arthritis & rheumatology (Hoboken, N.J.) Jul 2019. doi: 10.1002/art.40878 [Pubmed: 30835943]
Resources:
Hospital for Special Surgery www.hss.edu]
Accelerating Medicines Partnership Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE)? https://www.nih.gov/research-training/accelerating-medicines-partnership-amp/autoimmune-diseases-rheumatoid-arthritis-lupus]
Assays:
Assay TypeNumber of Exp. Samples
Protein microarray 45
RNA sequencing 45
Clinical Assessments:
Arthritis Evaluation
SDY1328: Transcriptional profiling of HBV-naive subjects before vaccination against Hepatitis A/B viruses, Diphtheria/Tetanus toxoids and Cholera.
Status: Updated
Description: Mechanisms of poor responses to vaccines remain unknown. Hepatitis B virus-naive elderly subjects received three vaccines, including a vaccine against hepatitis B virus (HBV). Pre-vaccination high dimensional analyses of blood using transcriptional profiling and flow cytometry revealed that subjects having increased memory B cell frequencies and higher expression of genes downstream of B cell receptor signaling responded more strongly to the HBV vaccine whereas subjects having higher expression of inflammatory related genes and greater numbers of activated innate immune cells showed a weaker response to this vaccine. The heme-induced response was associated with the poor response to the hepatitis B vaccine. Transcriptional profiling and flow cytometry results were validated in a distinct set of elderly subjects with accuracy greater than 60%. Our study is the first that identifies baseline predictors of responses to vaccines in a population of subjects known to be highly susceptible to infections.
Program/Contract:
ProgramContract
Other Programs Merck & Co. Inc
DOI: 10.21430/M3ID8ZC1AT
Subjects: 174
Study PI, contact:
NameOrganizationSite
Rafick-Pierre Sekaly Case Western Reserve University Case Western Reserve University
Publications:
Pre-vaccination inflammation and B-cell signalling predict age-related hyporesponse to hepatitis B vaccination.. Nature communications Jan 2016. doi: 10.1038/ncomms10369 [Pubmed: 26742691]
Resources:
ClinicalTrials.gov NCT01119703]
Gene Expression Omnibus GSE65834]
Assays:
Assay TypeNumber of Exp. Samples
Transcription profiling by array 342
Clinical Assessments:None
SDY1364: 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
Status: Updated
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-g) 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 Jul 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
ELISPOT 144
Transcription profiling by array 96
Clinical Assessments:None
SDY1464: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 2014
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 (HIPC) RFA-AI-14-007, RFA-AI-09-040 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M3AUKDIXFI
Subjects: 99
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.. Nature medicine Mar 2019. doi: 10.1038/s41591-019-0381-y [Pubmed: 30842675]
The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system.. Scientific data Oct 2019. doi: 10.1038/s41597-019-0213-4 [Pubmed: 31636302]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 504
Clinical Assessments:None
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