DR31 DataRelease

SDY1267: Malaria Vaccine in Healthy Adults
Status: New
Description: Approximately 168 healthy, malaria-naive volunteers aged 18 - 50 years, divided into 2 groups (84 in each group), will receive either one dose of Ad35.CS.01 followed by two doses of 257049 at monthly intervals or 3 doses of 257049 vaccine at monthly intervals. Of these, a maximum of 138 vaccinated volunteers will be challenged with P. falciparum infected mosquitoes. The challenge will occur 2 weeks following the third immunization. A group of up to 18 infectivity controls will begin participation in the study at the challenge stage. These controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals.
Program/Contract:
ProgramContract
DOI: 10.21430/M3FVO9SM7Y
Subjects: 67
Study PI, contact:
NameOrganizationSite
GSK Clinical Trials GSK Clinical Trials GlaxoSmithKline GSK Investigational Site Silver Spring, Maryland, United States, 20910
Publications:
Ad35.CS.01-RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naive Adults.. PLoS One. Jul 2015. doi: 10.1371/journal.pone.0131571. eCollection 2015. [Pubmed: 26148007]
Systems analysis of protective immune responses to RTS,S malaria vaccination in humans.. Proc Natl Acad Sci U S A. Feb 2017. doi: 10.1073/pnas.1621489114. Epub 2017 Feb 13. [Pubmed: 28193898]
Resources:
NCT01366534 https://clinicaltrials.gov/ct2/show/study/NCT01366534?view=record]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 583
Clinical Assessments:None
SDY1302: Prematurity, Respiratory outcomes, Immune System, and Microbiome Study (PRISM)
Status: New
Description: Enrollment min/max Age Unit is weeks Post-menstrual age at birth.
Program/Contract:
ProgramContract
Respiratory Pathogens Research Center (RPRC) Respiratory Pathogens Research Center (RPRC)
DOI: 10.21430/M3LBDA3IAM
Subjects: 225
Study PI, contact:
NameOrganizationSite
Pryhuber Gloria University of Rochester Medical Center University of Rochester
Publications:
T cell developmental arrest in former premature infants increases risk of respiratory morbidity later in infancy.. JCI Insight. Feb 2018. doi: 10.1172/jci.insight.96724. [Epub ahead of print] [Pubmed: 29467329]
Resources:
Respiratory Pathogen Research Center Studies https://www.urmc.rochester.edu/respiratory-pathogens-research-center/projects.aspx]
Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts on Lymphocyte and Respiratory Function in Infants Born Prematurely or Full Term https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001347.v2.p1]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 1863
Clinical Assessments:None
SDY1341: Vaginal Virome and Preterm Birth (See companion study SDY1206)
Status: New
Description: Despite decades of attempts to link infectious agents to preterm birth, an exact causative microbe or community of microbes remains elusive. Culture-independent sequencing of vaginal bacterial communities demonstrates community characteristics are associated with preterm birth, although none are specific enough to apply clinically. Viruses are important components of the vaginal microbiome and have dynamic relationships with vaginal bacterial communities. The authors hypothesized that vaginal eukaryotic DNA viral communities either alone or in the context of bacterial communities are associated with preterm birth. In this nested case-control study, serial mid-vaginal swabs were obtained at routine prenatal visits and bacterial communities and eukaryotic viral communities were characterized from extracted DNA. Viral communities were analyzed according to presence/absence of viruses, diversity, dynamics over time, and association with bacterial community data obtained from the same specimens.
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M31K9QN0OM
Subjects: 60
Study PI, contact:
NameOrganizationSite
Molly Stout Washington University in St Louis School of Medicine, St. Louis, MO Washington University in St Louis School of Medicine, St. Louis, MO
Publications:
The Vaginal Eukaryotic DNA Virome and Preterm Birth.. Am J Obstet Gynecol. May 2018. doi: - [Pubmed: 29738749]
Resources:
SRA ? Sequencing Data https://www.ncbi.nlm.nih.gov/bioproject/PRJNA294119/]
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 136
Whole Genome Sequencing 128
Clinical Assessments:
Preganancy Termor Preterm
SDY1363: Suspect screening for chemicals in pregnant women
Status: New
Description: In utero exposure to environmental chemicals can adversely impact pregnancy outcomes and childhood health but minimal biomonitoring data exist on the majority of chemicals used in commerce.
Program/Contract:
ProgramContract
NIH Revision Awards for Creating Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER) Transdisciplinary Approach To Rapidly Identify Reproductive Toxics In Pregnant Women And Newborns
Children's Environmental Health and Disease Prevention Research Centers UCSF Pregnancy Exposures To Environmental Chemicals (PEEC) Children's Center
DOI: 10.21430/M3ZWNRQPCG
Subjects: 75
Study PI, contact:
NameOrganizationSite
Tracey Woodruff UCSF Program on Reproductive Health and the Environment UCSF Program on Reproductive Health and the Environment
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Mass Spectrometry 75
Clinical Assessments:None
SDY1417: Pregnancy induces an earlier chronotype in both mice and women
Status: New
Description: Wrist actigraphy was obtained for two weeks before conception and then throughout pregnancy. Chronotype was measured by determining the time of sleep onset from the actigraphy profile of each 24-hour period (12 PM to 12 PM the next day) during the first (gestational weeks 4 through 13), second (weeks 14 through 27) and third trimesters (week 28 until delivery).
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M34RFPUKX4
Subjects: 0
Study PI, contact:
NameOrganizationSite
Erik Herzog Washington University in St. Louis March of Dimes Prematurity Research Center at Washington University
Publications:None
Resources:
March of Dimes Prematurity Research Center Washington University St. Louis https://prematurityresearch.wustl.edu/]
Assays:None
Clinical Assessments:None
SDY1436: Novel correlates of protection against influenza A(H1N1)pdm virus infection
Status: New
Description: Novel influenza virus vaccines that target more conserved epitopes of influenza viruses, specifically the hemagglutinin stalk and neuraminidase, are currently being developed. However, HA stalk antibodies have not yet been correlated with protection from natural infection in humans. We performed a household transmission study to identify alternative correlates of protection in naturally exposed individuals. Pre-existing antibody levels measured in hemagglutinin inhibition (HI) and ELISA assays were linked to the risk of PCR-confirmed infection and disease after exposure. We identified 50% protective titers and levels for HI, full-length HA, NA, and HA stalk. HI, HA stalk and NA antibodies all remained protective against infection and disease when adjusted for age. When additionally adjusted for other antibody levels, we found HI and HA stalk, but not NA antibodies to be independently protective against infection. Similar reductions were observed for symptomatic influenza. Furthermore, ELISA assays were found to accurately predict seroconversion in addition to traditional HI assays. This study establishes HA stalk antibodies as an additional correlate of protection against influenza virus infection in humans in a natural exposure scenario and supports the HA stalk as a target for novel universal influenza virus vaccine candidates.
Program/Contract:
ProgramContract
NIAID Program Dynamics Of Influenza Transmission In Nicaraguan Households
DOI: 10.21430/M3HXYMFM42
Subjects: 366
Study PI, contact:
NameOrganizationSite
Aubree Gordon University of Michigan University of Michigan
Publications:None
Resources:
Assays:None
Clinical Assessments:None
SDY1439: Adjuvanted influenza-H1N1 vaccination reveals lymphoid signatures of age-dependent early responses and of clinical adverse events.
Status: New
Description: Adjuvanted vaccines afford invaluable protection against disease, and the molecular and cellular changes they induce offer direct insight into human immunobiology. Here we show that within 24 h of receiving adjuvanted swine flu vaccine, healthy individuals made expansive, complex molecular and cellular responses that included overt lymphoid as well as myeloid contributions. Unexpectedly, this early response was subtly but significantly different in people older than _35 years. Wide-ranging adverse clinical events can seriously confound vaccine adoption, but whether there are immunological correlates of these is unknown. Here we identify a molecular signature of adverse events that was commonly associated with an existing B cell phenotype. Thus immunophenotypic variation among healthy humans may be manifest in complex pathophysiological responses.
Program/Contract:
ProgramContract
DOI: 10.21430/M3LJTCB0M1
Subjects: 196
Study PI, contact:
NameOrganizationSite
Adrian Hayday King's College London, Francis Crick Institute Peter Gorer Department of Immunobiology, ImmunoSurveillance Laboratory
Publications:
Adjuvanted influenza-H1N1 vaccination reveals lymphoid signatures of age-dependent early responses and of clinical adverse events.. Nature Immunology February 2016. doi: 10.1038/ni.3328 [Pubmed: 26726811]
Resources:
Publication https://www.nature.com/articles/ni.3328]
E-MTAB-2313.processed ftp://ftp.ebi.ac.uk/pub/databases/microarray/data/experiment/MTAB/E-MTAB-2313/E-MTAB-2313.processed.1.zip]
E-MTAB-2313.raw ftp://ftp.ebi.ac.uk/pub/databases/microarray/data/experiment/MTAB/E-MTAB-2313/E-MTAB-2313.raw.1.zip]
Assays:
Assay TypeNumber of Exp. Samples
Neutralizing Antibody Titer Assay 392
Transcription profiling by array 173
Clinical Assessments:None
SDY1473: Whole exome sequencing reveals HSPA1L as a genetic risk factor for spontaneous preterm birth
Status: New
Description: Preterm birth is the leading cause of infant mortality, and prematurity is further associated with serious morbidities in later life. Genetic and environmental risk factors play a role in the susceptibility to preterm birth. Despite numerous studies, the genetic basis for preterm birth remains poorly defined. We investigated the presence of rare, possibly risk associated nucleotide variants in mothers with spontaneous preterm births (SPTB). The first set of mothers with family history of recurrent preterm births was of northern Finnish origin. An additional set of mothers (sister pairs, both giving birth preterm) of European origin was also studied. Whole exome sequencing identified multiple rare, likely damaging HSPA1L variants in several families affected by SPTB, and this gene was associated with the glucocorticoid receptor signaling pathway. Potential involvement of one of the HSPA1L variants in SPTB was further supported by large GWAS dataset. In addition, this variant alters protein post-translational modification potential, and thus may affect protein stability and its function as a chaperone.
Program/Contract:
ProgramContract
DOI: 10.21430/M31DFMAKJW
Subjects: 0
Study PI, contact:
NameOrganizationSite
Loius Mugli Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center
Johanna Huusk University of Oulu University of Oulu
Publications:
Whole exome sequencing reveals HSPA1L as a genetic risk factor for spontaneous preterm birth.. PLoS Genet. Jul 2018. doi: 10.1371/journal.pgen.1007394. eCollection 2018 Jul. [Pubmed: 30001343]
Resources:
Assays:None
Clinical Assessments:None
SDY1474: Anthropoid primate specific retroviral element THE1B controls expression of CRH in placenta and alters gestation length
Status: New
Description: The proper timing of delivery is critical during pregnancy; if too early or too late, the baby will be at risk of serious health problems and even death. Corticotropin-releasing hormone (CRH) is a protein that can be detected in maternal blood, and its concentration correlates with the timing of birth. In humans and other anthropoid primates, CRH is made by the placenta, whereas in other mammals, it is produced in a specialized region of the brain. To understand the regulation and evolution of this key protein, we inserted the human CRH gene and nearby regions into the mouse genome, which resulted in human CRH expression in the mouse placenta. Mouse litters that make CRH in their placentas are born later than control mice, showing that CRH can directly affect birth timing. Using our mouse model, we then selectively deleted a remnant of an ancient retrovirus that is normally found in the DNA of anthropoid primates and demonstrated that this specific region controls expression of CRH in the placenta. Deletion of this region also restored normal birth timing in the mice by eliminating CRH production from the placenta. We propose that retroviral regulation of CRH in the placenta may be a mechanism of controlling birth timing in humans and other anthropoid primates.
Program/Contract:
ProgramContract
DOI: 10.21430/M3AZYDHB5Z
Subjects: 0
Study PI, contact:
NameOrganizationSite
Louis Mugli Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center
Publications:
Anthropoid primate-specific retroviral element THE1B controls expression of CRH in placenta and alters gestation length.. PLoS Biol. Sep 2018. doi: 10.1371/journal.pbio.2006337. eCollection 2018 Sep. [Pubmed: 30231016]
Resources:
Assays:None
Clinical Assessments:None
SDY1487: CD33 recruitment inhibits IgE-mediated anaphylaxis and desensitizes mast cells to allergen
Status: New
Description: Allergen immunotherapy for patients with allergies begins with weekly escalating doses of allergen under medical supervision to monitor and treat IgE mast cell?mediated anaphylaxis. There is currently no treatment to safely desensitize mast cells to enable robust allergen immunotherapy with therapeutic levels of allergen. Here, we demonstrated that liposomal nanoparticles bearing an allergen and a high-affinity glycan ligand of the inhibitory receptor CD33 profoundly suppressed IgE-mediated activation of mast cells, prevented anaphylaxis in Tg mice with mast cells expressing human CD33, and desensitized mice to subsequent allergen challenge for several days. We showed that high levels of CD33 were consistently expressed on human skin mast cells and that the antigenic liposomes with CD33 ligand prevented IgE-mediated bronchoconstriction in slices of human lung. The results demonstrated the potential of exploiting CD33 to desensitize mast cells to provide a therapeutic window for administering allergen immunotherapy without triggering anaphylaxis.
Program/Contract:
ProgramContract
Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) RFA-AI-16-065 Using Siglecs and their ligands to treat allergic diseases SALTAD
DOI: 10.21430/M37G7PMJ7E
Subjects: 0
Study PI, contact:
NameOrganizationSite
James Paulson The Scripps Research Institute The Scripps Research Institute
Publications:
CD33 recruitment inhibits IgE-mediated anaphylaxis and desensitizes mast cells to allergen.. J Clin Invest. Mar 2019. doi: 10.1172/JCI125456. Epub 2019 Feb 18. [Pubmed: 30645205]
Resources:
The Scripps Research Institute https://www.scripps.edu/]
Rutgers Institute for Translational Medicine and Science https://ritms.rutgers.edu/]
Assays:None
Clinical Assessments:None
SDY1502: Platelets attach to lung ILC2 expressing PSGL-1 and influence ILC2 function
Status: New
Description: Electron microscopy demonstrates that mouse lung ILC2 expressing PSGL-1 have platelets attached to their surface and that platelet depletion reduces lung ILC2 proliferation and Th2 cytokines suggesting ILC2 function is influenced by attachment to platelets
Program/Contract:
ProgramContract
Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) RFA-AI-16-065 Airway inflammation and airway remodeling
DOI: 10.21430/M3208RB6VB
Subjects: 26
Study PI, contact:
NameOrganizationSite
David Broide UCSD UCSD
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 203
Q-PCR 6
Clinical Assessments:None
SDY1503: Transcriptomes From Human Tissue Biopsies During Pregnancy
Status: New
Description: Spontaneous preterm labor is one of the leading causes of preterm birth and is associated with pathological changes in both the uterine myometrium and cervix The aim of this study was to understand how these changes occur at a cellular level. Samples of 310 single cell transcriptomes were derived from biopsies of tissues obtained from 4 pregnant women in their third trimester that underwent planned cesarean hysterectomies because of suspected morbidly adherent placentas. Using single cell transcriptomic analyses, different cell types obtained from cervical and uterine biopsies during late pregnancy were delineated using marker genes. Expressed genes were cross validated using the Human Protein Atlas. The cells were separated into 5 major groups using unbiased clustering of marker genes: endothelial, leukocytes, epithelial, smooth muscle, and stromal cells. Genes that separated the different cell types were observed to be genes whose coordinated expression drives that cell type?s specific biological function. In addition to cell type specific genes, enriched expression of genes implicated in active inflammatory processes were also observed. The single cell catalogue created during this study gives a deeper understanding of pathologies that occur during childbirth, including preterm births.
Program/Contract:
ProgramContract
DOI: None
Subjects: 0
Study PI, contact:
NameOrganizationSite
Stephen Quake Stanford University Stanford University
Publications:None
Resources:
NCBI BioProject https://www.ncbi.nlm.nih.gov/bioproject/PRJNA325371]
Assays:None
Clinical Assessments:None
SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling
Status: Updated
Description: Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling
DOI: 10.21430/M3OYWCJHO1
Subjects: 159
Study PI, contact:
NameOrganizationSite
Gregory Poland Mayo Clinic Mayo Clinic
Publications:
The impact of immunosenescence on humoral immune response variation after influenza A/H1N1 vaccination in older subjects.. PLoS One. Mar 2015. doi: 10.1371/journal.pone.0122282. eCollection 2015. [Pubmed: 25816015]
System-Wide Associations between DNA-Methylation, Gene Expression, and Humoral Immune Response to Influenza Vaccination.. PLoS One. Mar 2016. doi: 10.1371/journal.pone.0152034. eCollection 2016. [Pubmed: 27031986]
Gene signatures related to HAI response following influenza A/H1N1 vaccine in older individuals.. Heliyon. May 2016. doi: 10.1016/j.heliyon.2016.e00098. eCollection 2016. [Pubmed: 27441275]
Simultaneous enumeration of cancer and immune cell types from bulk tumor gene expression data.. Elife. Nov 2017. doi: 10.7554/eLife.26476. [Pubmed: 29130882]
Resources:
NIH Reporter 5U01AI089859-05 http://projectreporter.nih.gov/project_info_details.cfm?aid=8695082]
Assays:
Assay TypeNumber of Exp. Samples
Cell Culture 556
DNA methylation profiling assay 952
ELISPOT 1113
Flow Cytometry 3387
Hemagglutination Inhibition 1272
Mass Spectrometry 61
Meso Scale Discovery ECL 1272
PCR 466
Q-PCR 159
RNA sequencing 1100
Virus Neutralization 635
Clinical Assessments:None
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 1 (HIPC1) 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 Syst. Oct 2016. doi: 10.1016/j.cels.2016.09.009. Epub 2016 Oct 13. [Pubmed: 27746093]
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
Clinical Assessments:None
SDY1041: CMV CD8 T Cells
Status: Updated
Description: We present human T cell responses in multiple sites including blood, lymphoid, mucosal and secretory tissues of 20 CMV seropositive donors. Overall, CMV-specific T cells were maintained in distinct distribution patterns, either predominant in blood, bone marrow (BM) and lung, or lymph nodes (LN) with the frequency and function in blood distinct from tissues. Together, our results reveal tissue T cell reservoirs for CMV control, with global effects on T cell homeostasis over the human lifespan.
Program/Contract:
ProgramContract
Tissue compartmentalization of human lymphocytes P01AI106697 Tissue compartmentalization of human lymphocytes
DOI: 10.21430/M3MIPLU7ZU
Subjects: 20
Study PI, contact:
NameOrganizationSite
Donna Farber Columbia University CCTI
Publications:
Tissue reservoirs of antiviral T cell immunity in persistent human CMV infection.. J Exp Med. Mar 2017. doi: 10.1084/jem.20160758. Epub 2017 Jan 27. [Pubmed: 28130404]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 342
Clinical Assessments:None
SDY1178: Islet Transplantation in Type 1 Diabetes (CIT-07) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08)
Status: Updated
Description: The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. Subjects in CIT07, a single arm Phase 3 license-enabling study, received induction and maintenance immunosuppression in an open-label fashion consisting of rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus and low-dose tacrolimus.
Program/Contract:
ProgramContract
The Clinical Islet Transplantation Consortium ADVANCING ISLET TRANSPLANTS FOR TYPE 1 DIABETES CARE
The Clinical Islet Transplantation Consortium B-LYMPHOCYTE IMMUNOTHERAPY IN ISLET TRANSPLANTATION
The Clinical Islet Transplantation Consortium ISLET TRANSPLANT - COSTIMULATORY BLOCKADE WITH LEA29Y
The Clinical Islet Transplantation Consortium 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/M3P7Q1ZRXJ
Subjects: 48
Study PI, contact:
NameOrganizationSite
Bernhard Hering University of Minnesota University of Minnesota
Xunrong Luo Northwestern University Northwestern University
Olle Korsgren Uppsala Univ. Hospital Uppsala Univ. Hospital
Nicole Turgeon Emory University Emory University
Ali Naji University of Pennsylvania University of Pennsylvania
Andrew Posselt University of California, San Francisco University of California, San Francisco
Camillo Ricordi University of Miami University of Miami
James Shapiro University of Alberta University of Alberta
Dixon Kaufman University of Wisconsin University of Wisconsin
Publications:
Improvement in beta-cell secretory capacity after human islet transplantation according to the CIT07 protocol.. Diabetes. Aug 2013. doi: 10.2337/db12-1802. Epub 2013 Apr 29. [Pubmed: 23630300]
Insulin sensitivity index in type 1 diabetes and following human islet transplantation: comparison of the minimal model to euglycemic clamp measures.. Am J Physiol Endocrinol Metab. May 2014. doi: 10.1152/ajpendo.00667.2013. Epub 2014 Apr 1. [Pubmed: 24691031]
Restoration of Glucose Counterregulation by Islet Transplantation in Long-standing Type 1 Diabetes.. Diabetes. May 2015. doi: 10.2337/db14-1620. Epub 2014 Dec 18. [Pubmed: 25524910]
Consistency of quantitative scores of hypoglycemia severity and glycemic lability and comparison with continuous glucose monitoring system measures in long-standing type 1 diabetes.. Diabetes Technol Ther. Apr 2015. doi: 10.1089/dia.2014.0289. Epub 2015 Jan 28. [Pubmed: 25629445]
Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. Jul 2016. doi: 10.2337/dc15-1988. Epub 2016 Apr 18. [Pubmed: 27208344]
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.. Diabetes. Nov 2016. doi: b 2016 Jul 27. [Pubmed: 27465220]
Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes.. J Clin Endocrinol Metab. Nov 2016. doi: b 2016 Aug 29. [Pubmed: 27571180]
Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue.. J Clin Invest. Apr 2017. doi: 10.1172/JCI87993. Epub 2017 Mar 20. [Pubmed: 28319051]
Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.. Diabetes Care. May 2018. doi: 10.2337/dc17-1779. Epub 2018 Mar 21. [Pubmed: 29563196]
Resources:
CIT-07 ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/NCT00434811]
CIT-08 ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01369082]
NIDDK Repository https://repository.niddk.nih.gov/studies/cit-07/]
Clinical Islet Transplantation Consortium https://www.citisletstudy.org/]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 219
Clinical Assessments:
Blood Sugar and Hypoglycemic Events
CGMS
Clarke Score
FSIGT
GFR
Physical Examination
SDY1387: Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy (ICAC-29)
Status: Updated
Description: ICAC-29/MUPPITS-1 is a prospective, longitudinal, nested case-control study designed to identify changes in gene transcription predictive of and associated with asthma exacerbations in children ages 6 to 17 years with difficult-to-control, exacerbation-prone asthma. Participants will be followed prospectively for the onset of a cold and a subsequent asthma exacerbation. An internet-based asthma and cold symptom diary will be accessed by participants using a hand-held device. When the participant reports development of a cold, a clinic visit will be scheduled as soon as possible (within 48 hours of cold symptom onset) to collect blood and nasal samples. A second clinic visit will occur 4-6 days from the onset of cold symptoms to obtain samples after the initial cold, but prior to the use of systemic corticosteroids. Participants will be followed for up to two colds or approximately 6 months after Visit 0, whichever comes first.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3Q1C6388O
Subjects: 227
Study PI, contact:
NameOrganizationSite
Daniel Jackson University of Wisconsin University of Wisconsin
Matthew Altman University of Wisconsin University of Wisconsin
Publications:
Transcriptome networks identify mechanisms of viral and nonviral asthma exacerbations in children.. Nat Immunol. May 2019. doi: 10.1038/s41590-019-0347-8. Epub 2019 Apr 8. [Pubmed: 30962590]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02502890]
GEO https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE115824]
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 2068
Clinical Assessments:None
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