DR30 DataRelease

SDY616: Interferon Responses in Eczema Herpeticum (ADRN-01)
Status: New
Description: Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-g plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig)G2a. Recent studies have demonstrated that IFN-g generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-g induction leads to susceptibility to HSV infection in ADEH+ patients.
Program/Contract:
ProgramContract
Atopic Dermatitis Research Network (ADRN) 2011-2015 Atopic Dermatitis Research Network (ADRN)
DOI: 10.21430/M34DAGM5W4
Subjects: 84
Study PI, contact:
NameOrganizationSite
Donald Leung National Jewish Health National Jewish Health
Publications:
Identification of novel gene signatures in patients with atopic dermatitis complicated by eczema herpeticum.. J Allergy Clin Immunol. Oct 2014. doi: 10.1016/j.jaci.2014.07.018. Epub 2014 Aug 23. [Pubmed: 25159465]
Ankyrin repeat domain 1 regulates innate immune responses against herpes simplex virus 1: A potential role in eczema herpeticum.. J Allergy Clin Immunol. Jun 2018. doi: 10.1016/j.jaci.2018.01.001. Epub 2018 Jan 31. [Pubmed: 29371118]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01429311]
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 22
Clinical Assessments:None
SDY1162: Meta-Analysis of Vaginal Microbiome Data Provides New Insights On Preterm Birth
Status: New
Description: Preterm birth (PTB) is defined as the birth of an infant before 37 weeks of gestational age. It is the leading cause of perinatal morbidity and mortality worldwide, with 15 million preterm births per year. Vaginal microbiome more specifically is known to change throughout pregnancy, and can even affect the fetus before delivery. This study presents the first meta-analysis of vaginal microbiome in preterm birth. This study integrated raw 16S ribosomal RNA vaginal microbiome data from three pregnancy related studies consisting of over 300 pregnant patients sampled longitudinally over the three trimesters. It was found that women who later have a preterm delivery, have a higher variance in their vaginal microbiome, with the largest, most significant difference between term and preterm patients being in samples collected during the first trimester. While several of the microbial genera have been reported previously, three of those nine microbial genera are newly reported here. New hypotheses emerging from such an integrative analysis can lead to novel diagnostics to identify women who are at higher risk for PTB and potentially inform new therapeutic interventions.
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M3TRYB4WHX
Subjects: 202
Study PI, contact:
NameOrganizationSite
Marina Sirota University of California, San Francisco University of California, San Francisco
Publications:
Diversity of the vaginal microbiome correlates with preterm birth. Reproductive sciences January 2014. doi: 0.1177/1933719113488838 [Pubmed: 23715799]
The vaginal microbiota of pregnant women who subsequently have spontaneous preterm labor and delivery and those with a normal delivery at term.. Microbiome. May 2014. doi: 10.1186/2049-2618-2-18. eCollection 2014. [Pubmed: 24987521]
Temporal and spatial variation of the human microbiota during pregnancy.. Proc Natl Acad Sci U S A. Sep 2015. doi: 10.1073/pnas.1502875112. Epub 2015 Aug 17. [Pubmed: 26283357]
Resources:
Stanford MOD Prematurity Research Center http://prematurity.stanford.edu/]
UCSF ICHS http://ichs.ucsf.edu/]
Sirota Laboratory http://sirotalab.ucsf.edu/index.html]
Butte Laboratory http://buttelab.ucsf.edu/]
Assays:
Assay TypeNumber of Exp. Samples
16S rRNA gene sequencing 323
Clinical Assessments:None
SDY1256: Small Sample- Big Data: The Gambia
Status: New
Description: To enable characterization of the molecular ontogeny in early life, we developed a robust experimental and analytical approach that applies system biology tools to peripheral blood samples from human newborns
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Systems Biology To Identify Biomarkers Of Neonatal Vaccine Immunogenicity
DOI: 10.21430/M3IXMI1PCO
Subjects: 30
Study PI, contact:
NameOrganizationSite
Ofer Levy Boston Children's Hospital Boston Children's Hospital, Harvard Medical School
Publications:
Dynamic molecular changes during the first week of human life follow a robust developmental trajectory.. Nat Commun. Mar 2019. doi: 10.1038/s41467-019-08794-x. [Pubmed: 30862783]
Resources:
NIH Clinical trial https://clinicaltrials.gov/ct2/show/NCT03246230]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 52
Luminex xMAP 60
Mass Spectrometry 115
RNA sequencing 50
Clinical Assessments:None
SDY1343: Toward more predictable birthdays
Status: New
Description: Low-cost methods for monitoring fetal development could improve prenatal care, especially in low-resource settings. By measuring the levels of certain placental RNA transcripts in maternal blood, Ngo et al. developed two noninvasive blood tests that provide a window into the progression of individual pregnancies. In a small proof-of-concept study, the first blood test predicted fetal age and delivery date with an accuracy comparable to that of ultrasound. The second blood test, also examined in a small pilot study, discriminated women at risk of preterm delivery from those who delivered at full term. The next step will be to assess the reliability of the tests in large, blinded clinical trials.
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M3RP599G2M
Subjects: 69
Study PI, contact:
NameOrganizationSite
Stephen Quake March of Dimes Prematurity Research Center at Stanford University School of Medicine March of Dimes Prematurity Research Center at Stanford University School of Medicine
Mads Malbye Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark
Publications:
Noninvasive blood tests for fetal development predict gestational age and preterm delivery.. Science June 2018. doi: 10.1126/science.aar3819 [Pubmed: 29880692]
Resources:
SRA ? sequencing data https://www.ncbi.nlm.nih.gov/sra/?term=SRP130149]
GitHub ? analyses scripts https://github.com/miramou/pregnancy_cfRNA]
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 15
Clinical Assessments:None
SDY1361: B cell sequencing data from individuals with kidney transplantation
Status: New
Description: This data comes from peripheral blood from individuals that had a kidney transplantation. The study is a longitudinal study with data collected at time 0 (considered pre-transplant), 6 and 24 months after the transplant. They are classified in three clinical outcomes defined by pathology reads of serial allograft biopsies scored by Banff criteria and the chronic allograft damage index (CADI) score: Non progressors (NP; n=10) had low non incremental CADI score without acute rejection, progressors with no rejection (PNR; n=10) had incremental CADI score over 2 years without rejection, and progressors with rejection (PR; n=7) had incremental high CADI scores over 2 years with rejection episodes. This data reveal that the immune repertoire diversity of individuals that reject the organ is higher in comparison with those that did not reject the organ. Additionally, after 2 years of follow-up, patients who developed rejection show an overall reduction of B-celll diversity with persistence in and expansion of specific clones.
Program/Contract:
ProgramContract
DOI: 10.21430/M37EGAHB65
Subjects: 27
Study PI, contact:
NameOrganizationSite
Minnie Sarwal UCSF UCSF
Marina Sirota UCSF UCSF
Publications:
Steroid-free immunosuppression since 1999: 129 pediatric renal transplants with sustained graft and patient benefits.. Am J Transplant. Jun 2009. doi: 10.1111/j.1600-6143.2009.02640.x. Epub 2009 May 13. [Pubmed: 19459814]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00141037]
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 137
Clinical Assessments:
CADI
End Stage Renal Disese Cause
HLA Mismatch
Kidney Donation History
SDY1385: Flow Cytometry of T cells for TB Resistance Study
Status: New
Description: Intracellular Cytokine Staining data for human T cell responses to antigens specific to and not specific to Mycobacterium tuberculosis. COMPASS analysis shows that Ugandan TB ?resisters? exhibit IFNg-independent CD4 T cell responses, suggesting exposure to TB antigens despite negative test results.
Program/Contract:
ProgramContract
Mechanisms of Immune Protection from TB among HIV-infected Individuals (R01) RFA-AI-14-072 Resistance To MTB Infection In HIV Infected Individuals In Uganda And S. Africa
DOI: 10.21430/M3SA04CC03
Subjects: 47
Study PI, contact:
NameOrganizationSite
Chetan Seshadri University of Washington University of Washington
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 375
Clinical Assessments:None
SDY1412: Small Sample- Big Data- Papua New Guinea Newborn Pilot Study
Status: New
Description: To enable characterization of the molecular ontogeny in early life, we developed a robust experimental and analytical approach that applies system biology tools to peripheral blood samples from human newborns
Program/Contract:
ProgramContract
DOI: 10.21430/M3TEJV0F4I
Subjects: 27
Study PI, contact:
NameOrganizationSite
Ofer Levy Boston Children's Hospital Boston Children's Hospital, Harvard Medical School
Publications:None
Resources:
NIH Clinical trial https://clinicaltrials.gov/ct2/show/NCT03246230]
Project Report https://projectreporter.nih.gov/project_info_description.cfm?aid=9245969&icde=33437113]
Assays:
Assay TypeNumber of Exp. Samples
Mass Spectrometry 74
RNA sequencing 50
Clinical Assessments:None
SDY1432: Clinical Islet Transplantation Consortium (CITC)
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.
Program/Contract:
ProgramContract
DOI: 10.21430/M34PPEBZA7
Subjects: 0
Study PI, contact:
NameOrganizationSite
Bernhard Hering University of Minnesota University of Minnesota
Xunrong Luo Northwestern University Northwestern University
Olle Korsgren Uppsala Univ. Hospital Uppsala Univ. Hospital
Nicole Turgeon Emory University Emory University
Ali Naji University of Pennsylvania University of Pennsylvania
Andrew Posselt University of California, San Francisco University of California, San Francisco
Camillo Ricordi University of Miami University of Miami
James Shapiro University of Alberta University of Alberta
Dixon Kaufman University of Wisconsin University of Wisconsin
James Markmann Massachusetts General Hospital Massachusetts General Hospital
Jose Oberholzer University of Illinois University of Illinois
Publications:
Improvement in ?-cell secretory capacity after human islet transplantation according to the CIT07 protocol.. Diabetes. Aug 2013. doi: 10.2337/db12-1802. Epub 2013 Apr 29. [Pubmed: 23630300]
Improvement in insulin sensitivity after human islet transplantation for type 1 diabetes.. J Clin Endocrinol Metab. Nov 2013. doi: 10.1210/jc.2013-1764. Epub 2013 Oct 1. [Pubmed: 24085506]
Insulin sensitivity index in type 1 diabetes and following human islet transplantation: comparison of the minimal model to euglycemic clamp measures.. Am J Physiol Endocrinol Metab. May 2014. doi: 10.1152/ajpendo.00667.2013. Epub 2014 Apr 1. [Pubmed: 24691031]
Restoration of Glucose Counterregulation by Islet Transplantation in Long-standing Type 1 Diabetes.. Diabetes. May 2015. doi: 10.2337/db14-1620. Epub 2014 Dec 18. [Pubmed: 25524910]
Consistency of quantitative scores of hypoglycemia severity and glycemic lability and comparison with continuous glucose monitoring system measures in long-standing type 1 diabetes.. Diabetes Technol Ther. Apr 2015. doi: 10.1089/dia.2014.0289. Epub 2015 Jan 28. [Pubmed: 25629445]
Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. Jul 2016. doi: 10.2337/dc15-1988. Epub 2016 Apr 18. [Pubmed: 27208344]
Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation.. Diabetes. Sep 2016. doi: 10.2337/db16-0222. Epub 2016 Jun 20. [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: 2016 Jul 27. [Pubmed: 27465220]
Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes.. J Clin Endocrinol Metab. Nov 2016. doi: 2016 Aug 29. [Pubmed: 27571180]
Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue.. J Clin Invest. Apr 2017. doi: 10.1172/JCI87993. Epub 2017 Mar 20. [Pubmed: 28319051]
Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. May 2018. doi: 10.2337/dc17-1779. Epub 2018 Mar 21. [Pubmed: 29563196]
Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation.. Transplantation. Mar 2019. doi: 10.1097/TP.0000000000002425. [Pubmed: 30211831]
Resources:
CITC https://www.citisletstudy.org/]
NIDDK https://repository.niddk.nih.gov/studies/citc/]
clinicaltrials.gov CIT-01 https://clinicaltrials.gov/ct2/show/NCT00789308]
NIDDK CIT-02 https://repository.niddk.nih.gov/studies/cit-02/]
clinicaltrials.gov CIT-02 https://clinicaltrials.gov/ct2/show/NCT00464555]
NIDDK CIT-03 https://repository.niddk.nih.gov/studies/cit-03/]
clinicaltrials.gov CIT-03 https://clinicaltrials.gov/ct2/show/NCT00434850]
NIDDK CIT-04 https://repository.niddk.nih.gov/studies/cit-04/]
clinicaltrials.gov CIT-04 https://clinicaltrials.gov/ct2/show/NCT00468403]
NIDDK CIT-05 https://repository.niddk.nih.gov/studies/cit-0501/]
clinicaltrials.gov CIT-05 https://clinicaltrials.gov/ct2/show/NCT00468442]
clinicaltrials.gov CIT-06 https://clinicaltrials.gov/ct2/show/NCT00468117]
NIDDK CIT-07 https://repository.niddk.nih.gov/studies/cit-07/]
clinicaltrials.gov CIT-07 https://clinicaltrials.gov/ct2/show/NCT00434811]
clinicaltrials.gov CIT-08 https://clinicaltrials.gov/ct2/show/NCT01369082]
Assays:None
Clinical Assessments:None
SDY1437: Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation
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. CIT01 participants were randomized to study treatment including Low Molecular Weight Sulfated Dextran (LMW-DS) and study treatment without LMW-DS. Subjects in both arms received induction and maintenance immunosuppression consisting of ATG (basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus. CIT01 subjects randomized to the LMW-DS arm also received LMW-DS before and during islet transplant.
Program/Contract:
ProgramContract
DOI: 10.21430/M3YZY4PXCS
Subjects: 24
Study PI, contact:
NameOrganizationSite
Olle Korsgren Uppsala University Hospital Uppsala University Hospital
Publications:
Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation.. Transplantation. Mar 2019. doi: 10.1097/TP.0000000000002425. [Pubmed: 30211831]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00789308]
NIDDK Repository https://repository.niddk.nih.gov/studies/cit-01/]
Clinical Islet Transplantation Consortium https://www.citisletstudy.org/]
Assays:None
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1446: Comparing aerosol and intradermal boost regimes of candidate TB vaccine MVA85A.
Status: New
Description: There is an urgent need for an effective tuberculosis (TB) vaccine. Heterologous prime-boost regimens with recombinant viral vectors are effective at inducing induce high levels of potent cellular immunity. MVA85A is a candidate TB vaccine designed to boost BCG-induced immunity. This phase I experimental medicine clinical trial was designed to evaluate whether alternating aerosol and intradermal vaccination routes would boost the immune response cellular immunity to the Mycobacterium tuberculosis antigen 85A.
Program/Contract:
ProgramContract
NIHR Biomedical Research Centres (BRCs) NIHR Biomedical Research Centre at Oxford University Hospitals NHS Foundation Trust and the University of Oxford
DOI: 10.21430/M3ER3DU6NW
Subjects: 37
Study PI, contact:
NameOrganizationSite
Helen McShane University of Oxford Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Publications:None
Resources:
ClinicalTrials.gov Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A https://clinicaltrials.gov/ct2/show/NCT01954563]
EU Clinical Trials Register (N.B. EudraCT does not display phase 1 trials) 2013-002020-16]
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 792
Clinical Assessments:
Bronchoscopy
SDY56: Systems Biology of 2010 trivalent Influenza vaccine (TIV) in young and elderly (see companion study SDY61 2007, SDY270 2009, SDY119 2011)
Status: Updated
Description: Study Objective
To identify innate signatures that correlate with the magnitude, quality and persistence of B cell responses after vaccination with TIV in the young versus the elderly.

Study Design
Single center, open label study in which adult healthy volunteers with no contraindications to immunization will be vaccinated with TIV. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30, D180 post vaccination to study innate and/or adaptive immunity markers. Even though influenza vaccination is considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Volunteers will be also asked to report local and systemic AEs developing the day of a blood draw.
Additionally, only AEs considered related (unlikely, possibly, probably or definitely related) will be collected and reported in this study from Day 0 (vaccination) to Day 180. After Day 30 only related SAEs will be collected and reported.

Study Duration
12 months (6 months accrual and 6 months follow-up period)
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Biological Analysis of Innate and Adaptive Responses to Vaccination
DOI: 10.21430/M3X9SKF8RQ
Subjects: 70
Study PI, contact:
NameOrganizationSite
Bali Pulendran Emory University Emory University
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 745
Hemagglutination Inhibition 324
Luminex xMAP 240
microRNA profiling assay 288
Transcription profiling by array 288
Clinical Assessments:None
SDY80: Cellular and molecular characterization of the immune response in healthy NIH employees at baseline and after immunization with the H1N1 or seasonal influenza vaccines
Status: Updated
Description: The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects (NIH employees) prior to vaccination and then at various time points after receiving the FDA-licensed seasonal and H1N1 influenza vaccine. These samples will be used to perform a comprehensive and detailed analysis of the immune system at baseline and in response to vaccination. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in a large number of healthy adults (NIH employees). This information may be useful in designing newer, more effective vaccines to prevent the spread of H1N1 influenza.
Program/Contract:
ProgramContract
NIH Center for Human Immunology, Autoimmunity and Inflammation (CHI) Center for Human Immunology, Autoimmunity and Inflammation
DOI: 10.21430/M3STAI2V6T
Subjects: 64
Study PI, contact:
NameOrganizationSite
John Tsang NIH NIH
Publications:
Global analyses of human immune variation reveal baseline predictors of postvaccination responses.. Cell. Apr 2014. doi: 10.1016/j.cell.2014.03.031. [Pubmed: 24725414]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 227
Flow Cytometry 2137
Transcription profiling by array 301
Virus Neutralization 564
Clinical Assessments:None
SDY888: Human Immune Signature of Dengue virus infection- Gene Expression of CD4 subsets
Status: Updated
Description: The human Immune Signature of Dengue virus infection was studied in two endemic areas. T cell responses were compared in infected patients and uninfected individuals also from Dengue endemic areas.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (HIPC2)
DOI: 10.21430/M3C4L4WD2Z
Subjects: 92
Study PI, contact:
NameOrganizationSite
Alessandro Sette La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
Unique phenotypes and clonal expansions of human CD4 effector memory T cells re-expressing CD45RA.. Nat Commun. Nov 2017. doi: 10.1038/s41467-017-01728-5. [Pubmed: 29133794]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 14
HLA Typing 13
RNA sequencing 74
Clinical Assessments:None
SDY984: Zoster vaccine in young and elderly
Status: Updated
Description: Study objective: To analyze the generic innate immune signatures that correlate with the magnitude of the adaptive immune responses (by gamma-interferon ELISPOT, responder-cell frequency (RCF) and flow cytometric studies) in young and elderly populations in order to identify the correlation signatures of the innate immune responses to Zoster vaccine.Study design: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected during a screening visit (between days D-56 to D-14) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 post vaccination to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Systems Biological Analysis of Innate and Adaptive Responses to Vaccination HIPC2
DOI: 10.21430/M36N1BYFT5
Subjects: 77
Study PI, contact:
NameOrganizationSite
Nadine Rouphael Emory Hope Clinic Emory
Myron Levin Vaccine Research Trials Center Denver
Publications:
Metabolic Phenotypes of Response to Vaccination in Humans.. Cell. May 2017. doi: 10.1016/j.cell.2017.04.026. Epub 2017 May 11. [Pubmed: 28502771]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 411
ELISPOT 557
Flow Cytometry 1166
Luminex xMAP 100
Mass Spectrometry 360
Q-PCR 306
Transcription profiling by array 288
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 (AMP) Accelerating Medicines Partnership (AMP)
DOI: 10.21430/M35FLWNXH1
Subjects: 107
Study PI, contact:
NameOrganizationSite
PJ Utz Stanford PEARL
Michael Holers Colorado PEARL
Publications:None
Resources:
NIH AMP RA/SLE Program https://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp]
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 (AMP) Accelerating Medicines Partnership (AMP)
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:None
Resources:
NIH AMP RA/SLE Program https://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 175
Flow Cytometry 309
Microscopy 421
RNA sequencing 10189
Clinical Assessments:
Medical History
SDY1294: A Systems Vaccinology Approach Reveals Temporal Transcriptomic Changes of Immune Responses to the Yellow Fever 17D Vaccine.
Status: Updated
Description: In this study, we used a systems vaccinology approach to identify temporal changes in immune response signatures to the yellow fever (YF)-17D vaccine, with the aim of comprehensively characterizing immune responses associated with protective immunity. We conducted a cohort study in which 21 healthy subjects in China were administered one dose of the YF-17D vaccine; PBMCs were collected at 0 h and then at 4 h and days 1, 2, 3, 5, 7, 14, 28, 84, and 168 postvaccination, and analyzed by transcriptional profiling and immunological assays. At 4 h postvaccination, genes associated with innate cell differentiation and cytokine pathways were dramatically downregulated, whereas receptor genes were upregulated, compared with their baseline levels at 0 h. Immune response pathways were primarily upregulated on days 5 and 7, accompanied by the upregulation of the transcriptional factors JUP, STAT1, and EIF2AK2. We also observed robust activation of innate immunity within 2 d postvaccination and a durable adaptive response, as assessed by transcriptional profiling. Coexpression network analysis indicated that lysosome activity and lymphocyte proliferation were associated with dendritic cell (DC) and CD4+ T cell responses; FGL2, NFAM1, CCR1, and TNFSF13B were involved in these associations. Moreover, individuals who were baseline-seropositive for Abs against another flavivirus exhibited significantly impaired DC, NK cell, and T cell function in response to YF-17D vaccination. Overall, our findings indicate that YF-17D vaccination induces a prompt innate immune response and DC activation, a robust Ag-specific T cell response, and a persistent B cell/memory B cell response.
Program/Contract:
ProgramContract
DOI: 10.21430/M3LT8WVHVH
Subjects: 21
Study PI, contact:
NameOrganizationSite
Yiming Shao Chinese Center for Disease Control and Prevention State Key Laboratory of Infectious Disease Prevention and Control
Publications:
A Systems Vaccinology Approach Reveals Temporal Transcriptomic Changes of Immune Responses to the Yellow Fever 17D Vaccine.. Journal of Immunology August 2017. doi: https://doi.org/10.4049/jimmunol.1700083 [Pubmed: 28687661]
Resources:
Publication http://www.jimmunol.org/content/199/4/1476.long]
NCBI GEO https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE82152]
Assays:
Assay TypeNumber of Exp. Samples
Neutralizing Antibody Titer Assay 63
Transcription profiling by array 109
Clinical Assessments:None
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