DR21 DataRelease

SDY59: Generation of Memory T cells In Young Healthy and Immunocompromised Populations
Status: New
Description: To expand our study of T cell memory repertoires to include healthy children who should still be in the process of generating memory repertoires. These studies will provide data about the age dynamics of memory repertoires. In addition to children, we will examine flu-specific memory repertoires in children with autoimmune diseases who are undergoing mild immunosuppression. This should describe the effects of immunosuppressive therapy on memory formation and function.
Program/Contract:
ProgramContract
Immune Function and Biodefense in Children, Elderly, and Immunocompromised Populations Generation and Decay of Memory T Cell in Young, Old and Immunocompromised Populations
DOI: 10.21430/M3PUJHYDDZ
Subjects: 223
Study PI, contact:
NameOrganizationSite
Jack Gorski BloodCenter of Wisconsin Children's Hospital of Wisconsin
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 187
Clinical Assessments:None
SDY313: HLA Genetics in Pediatric Arthritis
Status: New
Description: JRA (also known as JIA) includes the commonest chronic autoimmune arthropathies of childhood. The MHC is involved with respect to risk, either susceptibility or protection in a subtype specific manner with strong gender bias and differences between ethnicities. Multiple MHC effects have been shown, especially in the commonest subtype, so called early onset pauciarticular JRA (Persistent Oligo in the JIA terminology) with three or more MHC regions believed to interact in generating susceptibility. An additional feature of the disease, unlike some other forms of autoimmunity, is the relative absence of common extended or ancestral haplotypes, especially those carrying HLA-DR4 and HLA-DR7 both of which are protective. The three regions include a class I region, or an area telomeric to it, and two class II regions those around HLA DR/DQ and HLA-DP. None of the regions involved are well defined nor were the specific genes involved identified. The alleles marking these regions (HLA-DR8, 11 and HLA-DPB1*0201) are atypical for autoimmunity. This is therefore an unusual MHC contribution to autoimmunity, the elucidation of which lends itself to high throughput technologies. The genetic features, although involving arthritis, are quite distinct from adult rheumatoid arthritis except for about 5% of older children. It is proposed to construct high throughput SNP maps in a family based study. Subtypes have different MHC profiles and in the rarest and most severe form of disease, systemic onset JRA, the MHC effect is rather minimal. In this form, preliminary data involving KIR gene haplotypes is available. Pursuing these KIR gene observations is proposed. The ability to leverage ongoing phenotyping and family based sample collection ensures a large and continuously growing pool of available DMAs for this project. Some of the patients will also have extensive gene expression studies allowing a comprehensive approach to the MHC and KIR genes in JRA and its subtypes.
Program/Contract:
ProgramContract
HLA Region Genetics in Immune-mediated Diseases I HLA/KIR Region Genetics in Pediatric Arthritis
DOI: 10.21430/M33Z8QHOKB
Subjects: 1156
Study PI, contact:
NameOrganizationSite
David Glass Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center
Publications:
Sequence feature variant type (SFVT) analysis of the HLA genetic association in juvenile idiopathic arthritis.. Pac Symp Biocomput. Nov 2009. doi: - [Pubmed: 19908388]
Juvenile idiopathic arthritis and HLA class I and class II interactions and age-at-onset effects.. Arthritis Rheum. Jun 2010. doi: 10.1002/art.27424. [Pubmed: 20191588]
Biologic similarities based on age at onset in oligoarticular and polyarticular subtypes of juvenile idiopathic arthritis.. Arthritis Rheum. Nov 2010. doi: 10.1002/art.27657. [Pubmed: 20662067]
The susceptibility loci juvenile idiopathic arthritis shares with other autoimmune diseases extend to PTPN2, COG6, and ANGPT1.. Arthritis Rheum. Nov 2010. doi: 10.1002/art.27688. [Pubmed: 20722033]
Dense genotyping of immune-related disease regions identifies 14 new susceptibility loci for juvenile idiopathic arthritis.. Nat Genet. Jun 2013. doi: 10.1038/ng.2614. Epub 2013 Apr 21. [Pubmed: 23603761]
Conditional asymmetric linkage disequilibrium (ALD): extending the biallelic r2 measure.. Genetics. Sep 2014. doi: 10.1534/genetics.114.165266. Epub 2014 Jul 14. [Pubmed: 25023400]
Fine-mapping the MHC locus in juvenile idiopathic arthritis (JIA) reveals genetic heterogeneity corresponding to distinct adult inflammatory arthritic diseases.. Ann Rheum Dis. Dec 2016. doi: - [Pubmed: 27998952]
Resources:
dbGaP http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000494.v1.p1&phv=171340&phd=&pha=&pht=2798&phvf=2&phdf=&phaf=&phtf=1&dssp=1&consent=&temp=1]
Assays:
Assay TypeNumber of Exp. Samples
HLA Typing 1155
SNP microarray 1026
Clinical Assessments:None
SDY522: Differences in Antibody Responses Between Trivalent Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine (2011-12) Correlate With the Kinetics and Magnitude of Interferon Signaling in Children (see companion studies SDY144, SDY360)
Status: New
Description: The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3XZMA3XL4
Subjects: 20
Study PI, contact:
NameOrganizationSite
Octavio Ramilo Nationwide Children's Hospital Nationwide Children's Hospital
Publications:
Differences in antibody responses between trivalent inactivated influenza vaccine and live attenuated influenza vaccine correlate with the kinetics and magnitude of interferon signaling in children.. J Infect Dis. Jul 2014. doi: 10.1093/infdis/jiu079. Epub 2014 Feb 4. [Pubmed: 24495909]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 72
Flow Cytometry 64
Hemagglutination Inhibition 36
Virus Neutralization 108
Clinical Assessments:
Medical History
Vaccination History
Vital Signs
SDY572: Host responses to Enteroaggregative Escherichia coli (EAEC) infection
Status: New
Description: Enteroaggregative Escherichia coli (EAEC) is increasingly recognized as a major cause of diarrheal disease globally. In the current study, we investigated the impact of zinc deficiency on the host and pathogenesis of EAEC. Several outcomes of EAEC infection were investigated including weight loss, EAEC shedding and tissue burden, leukocyte recruitment, intestinal cytokine expression, and virulence expression of the pathogen in vivo. Mice fed a protein source defined zinc deficient diet (dZD) had an 80% reduction of serum zinc and a 50% reduction of zinc in luminal contents of the bowel compared to mice fed a protein source defined control diet (dC). When challenged with EAEC, dZD mice had significantly greater weight loss, stool shedding, mucus production, and, most notably, diarrhea compared to dC mice. Zinc deficient mice had reduced infiltration of leukocytes into the ileum in response to infection suggesting an impaired immune response. Interestingly, expression of several EAEC virulence factors were increased in luminal contents of dZD mice. These data show a dual effect of dietary zinc in benefitting the host while impairing virulence of the pathogen. The study demonstrates the critical importance of zinc and may help elucidate the benefits of zinc supplementation in cases of childhood diarrhea and malnutrition.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3G6QJN9D5
Subjects: 159
Study PI, contact:
NameOrganizationSite
Raquel Hontecillas NIMML UVA
Richard Guerrant UVA UVA
Josep Bassaganya-Riera NIMML VBI
Publications:
Zinc deficiency alters host response and pathogen virulence in a mouse model of enteroaggregative Escherichia coli-induced diarrhea.. Gut Microbes. - 2014. doi: 10.4161/19490976.2014.969642. [Pubmed: 25483331]
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 96
Mass Spectrometry 15
Other 280
Q-PCR 184
Clinical Assessments:None
SDY579: Assessing the role of NLRX1 during mucosal immune responses to H. pylori in mice
Status: New
Description: Helicobacter pylori (HP) colonizes 50% of the world’s population resulting in a decades-long gastric infection. Bacterial interaction with host intracellular environment occurs via injection of bacterial components through a TIVSS or intracellular replication. HP has been recognized for its ability to modulate intracellular NOD-like receptors (NLR). Host responses toward the bacterium can result in asymptomatic, pathogenic or even favorable immunity. Mechanisms underlying the dual role of HP as a commensal versus pathogen are not completely understood. We combined computational modeling, bioinformatics and experimental validation to investigate intracellular host-HP interactions. Global transcriptomic analysis on bone marrow-derived macrophages (BMDM) in a gentamycin protection assay unveiled that intracellular colonization of HP upregulated NOD1, NOD2, NLRP3, NLRC5 and inflammasome components (Caspase-1 and -11) but suppressed regulatory NLRX1 which was inversely correlated to TRAF6, NF-B, proinflammatory cytokines and reactive oxygen species. Loss of NLRX1 facilitates bacterial clearance in BMDM and infected mice. Lastly, we constructed a computational model to shed light on complex immune responses and pathway crosstalk regulated by NLRX1 during infection. In conclusion, NLRX1 is associated with chronic bacterial persistence during H. pylori infection and it may represent an immune evasion mechanism employed by the bacterium to facilitate long-term host colonization.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3L7JSJOLT
Subjects: 161
Study PI, contact:
NameOrganizationSite
Raquel Hontecillas NIMML VBI
Josep Bassaganya-Riera NIMML VBI
Publications:
Modeling the Regulatory Mechanisms by Which NLRX1 Modulates Innate Immune Responses to Helicobacter pylori Infection.. PLoS One. Sep 2015. doi: 10.1371/journal.pone.0137839. eCollection 2015. [Pubmed: 26367386]
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 74
Other 202
Q-PCR 45
Clinical Assessments:None
SDY587: Effect of tissue-specific PPARg deficiency in bacterial loads
Status: New
Description: In this study WT, CD4 cre+ and LysMcre- mice were infected with H. pylori strain SS1 for six months.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3F6N2WGKO
Subjects: 747
Study PI, contact:
NameOrganizationSite
Raquel Hontecillas NIMML VBI
Josep Bassaganya-Riera NIMML VBI
Publications:None
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
Other 450
Sequencing 72
Clinical Assessments:None
SDY588: Zinc and tryptophan effects on immunology
Status: New
Description: WT mice fed either nourished or RBD-Zn diet for two weeks. +/- antibiotic pre-Rx then 042wt infected to determine effect of antibiotics in model.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3O8LDLDTM
Subjects: 115
Study PI, contact:
NameOrganizationSite
Richard Guerrant UVA UVA
Publications:None
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
Other 120
Q-PCR 254
Clinical Assessments:None
SDY598: HP45
Status: New
Description: Eight to thirteen-weeks-old wild-type and LysMcre mice were infected with two doses (days 0 and 2) of 5x10e7 CFU of either H. pylori strain SS1 or mutant ChePep resuspended in 1X PBS. An uninfected group receiving 1X PBS was included.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3XE9NAP4K
Subjects: 674
Study PI, contact:
NameOrganizationSite
Raquel Hontecillas NIMML VBI
Josep Bassaganya-Riera NIMML VBI
Publications:None
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 1640
Other 241
Clinical Assessments:None
SDY601: HP47
Status: New
Description: WT and PPARgfl/fl:LysCre+ (R2+) mice were infected with 5x10e7 CFU of different Helicobacter pylori strains (26695, SS1 and PMSS1). A control uninfected group was included for each genotype. Tissues were collected at 9 months post-infection to determine bacterial loads (stomach) and to assess the expansion of CD4 and CD8 T cells, macrophages, dendritic cells and neutrophils by flow cytometry (blood, spleen and stomach).
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense II Virginia Bioinformatics Institute Modeling Immunity for Biodefense Contract
DOI: 10.21430/M3SB5VLQDV
Subjects: 426
Study PI, contact:
NameOrganizationSite
Raquel Hontecillas NIMML VBI
Josep Bassaganya-Riera NIMML VBI
Publications:None
Resources:
MIEP http://www.modelingimmunity.org/]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 1018
Other 182
Clinical Assessments:None
SDY751: MS3 peptide detection
Status: New
Description: MS3 peptide detection
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Crossprotective CTL Against Influenza
DOI: 10.21430/M39TACCIAJ
Subjects: 1
Study PI, contact:
NameOrganizationSite
Reinhold Dr. Harvard Medical School Dana Farber Cancer Institute
Publications:
Physical detection of influenza A epitopes identifies a stealth subset on human lung epithelium evading natural CD8 immunity.. Proc Natl Acad Sci U S A. Feb 2015. doi: 10.1073/pnas.1423482112. Epub 2015 Feb 2. [Pubmed: 25646416]
Resources:
Reinherz Lab http://dms.hms.harvard.edu/immunology/fac/Reinherz.php]
Assays:None
Clinical Assessments:None
SDY839: Measles Immunity
Status: New
Description: None
Program/Contract:
ProgramContract
Immunogenetics of Measles Immunity Immunogenetics of Measles Immunity
DOI: 10.21430/M3XWLPC8A2
Subjects: 2681
Study PI, contact:
NameOrganizationSite
Gregory Poland Mayo Clinic Mayo Clinic
Publications:
A large population-based association study between HLA and KIR genotypes and measles vaccine antibody responses.. PLoS One. Feb 2017. doi: 10.1371/journal.pone.0171261. eCollection 2017. [Pubmed: 28158231]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISPOT 14598
Sequencing 54
Virus Neutralization 2626
Clinical Assessments:None
SDY983: A Mouse Model of Chronic West Nile Virus
Status: New
Description: Using the Collaborative Cross, a population of recombinant inbred mouse strains with high levels of standing genetic variation, we have identified a mouse model of persistent WNV disease, with persistence of viral loads within the brain.
Program/Contract:
ProgramContract
Systems Approach to Immunity and Inflammation Systems Immunogenetics of Biodefense Pathogens in the Collaborative Cross
DOI: 10.21430/M3D8E1D6Z8
Subjects: 121
Study PI, contact:
NameOrganizationSite
Jennifer Lund Fred Hutchinson Cancer Research Center Fred Hutchinson Cancer Research Center
Publications:
A Mouse Model of Chronic West Nile Virus Disease.. PLoS Pathog. Nov 2016. doi: 10.1371/journal.ppat.1005996. eCollection 2016. [Pubmed: 27806117]
Resources:
Assays:None
Clinical Assessments:
Physical Exam
SDY1015: MaHPIC: Host M. mulatta infected with P. cynomolgi
Status: New
Description: Malaria-naive male rhesus macaques (Macaca mulatta), approximately three years of age, were inoculated intravenously with salivary gland sporozoites produced and isolated at the Centers for Disease Control and Prevention from multiple Anopheles species (An. dirus, An. gambiae, and An. stephensi) and then profiled for clinical, hematological, parasitological, immunological, functional genomic, lipidomic, proteomic, and metabolomic measurements. The experiment was designed for 100 days, and pre- and post-100 day periods to prepare subjects and administer curative treatments respectively. The anti-malarial drug artemether was subcuratively administered selectively to several subjects during the primary parasitemia to suppress clinical complications and to all animals for curative treatment of blood-stage infections to allow detection of relapses. One subject was euthanized during the 100-day experimental period due to clinical complications. The anti-malarial drugs primaquine and chloroquine were administered to all remaining subjects at the end of the study for curative treatment of the liver and blood-stage infections, respectively. Capillary blood samples were collected daily for the measurement of CBCs, reticulocytes, and parasitemias. Capillary blood samples were collected every other day to obtain plasma for metabolomic analysis. Venous blood and bone marrow samples were collected at seven time points for functional genomic, proteomic, lipidomic, and immunological analyses. Within the MaHPIC, this project is known as "Experiment 04". This dataset was produced by Mary Galinski, Rabindra Tirouvaniziam and Tracey Lamb at Emory University. The experimental design and protocols for this study were approved by the Emory University Institutional Animal Care and Use Committee (IACUC).
Program/Contract:
ProgramContract
Systems Biology for Infectious Diseases Research Integrated Approach To Host-Pathogen Interactions
DOI: 10.21430/M3DLU018LB
Subjects: 5
Study PI, contact:
NameOrganizationSite
Mary Galinski Emory University N/A
Publications:
Plasmodium cynomolgi infections in rhesus macaques display clinical and parasitological features pertinent to modelling vivax malaria pathology and relapse infections.. Malar J. Sep 2016. doi: 10.1186/s12936-016-1480-6. [Pubmed: 27590312]
Resources:
MaHPIC Project Website http://www.systemsbiology.emory.edu/]
MaHPIC Data Website http://plasmodb.org/plasmo/mahpic.jsp]
Assays:
Assay TypeNumber of Exp. Samples
Cytometric Bead Array Assay 31
Flow Cytometry 381
Clinical Assessments:None
SDY1: Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered with Omalizumab (an anti-IgE Monoclonal Antibody)
Status: Updated
Description:

Allergic rhinitis affects 20 to 40 million Americans annually. Allergy symptoms, which can range from mild to seriously debilitating, may affect quality of life. Left untreated, allergic rhinitis can exacerbate or trigger more serious conditions, such as asthma and sinus inflammation.

Individuals with allergies react to harmless particles such as dust or pollen. Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response. The immune response results in harmful inflammation of healthy tissues. In ragweed allergy, inflammation occurs in the airways and causes familiar allergy symptoms like sneezing, coughing, and general discomfort.

Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies. The blocking effect of omalizumab is temporary, but giving the drug to people before their regular allergy shots may make the shots more effective.

Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots (given over 12 weeks). The participants will return for follow-up for up to one year, and they may have as many as 27 study visits.

Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network - Casale
DOI: 10.21430/M38Y09R3R9
Subjects: 159
Study PI, contact:
NameOrganizationSite
Thomas Casale Creighton University School of Medicine Creighton University
Publications:
Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis.. J Allergy Clin Immunol. Jan 2006. doi: b 2005 Dec 2. [Pubmed: 16387596]
Combination treatment with omalizumab and rush immunotherapy for ragweed-induced allergic rhinitis: Inhibition of IgE-facilitated allergen binding.. J Allergy Clin Immunol. Sep 2007. doi: b 2007 Jul 12. [Pubmed: 17631952]
Resources:
Clinicaltrials.gov http://clinicaltrials.gov/ct2/show/NCT00078195]
ImmuneTolerance.org http://www.immunetolerance.org/studies/efficacy-and-safety-evaluation-allergen-immunotherapy-co-administered-with-omalizumab-anti-i]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 4376
Flow Cytometry 14462
Clinical Assessments:
15 mins post injection allergy skin reaction measurement
24 hrs post injection allergy skin reaction measurement
Allergen History
Allergy Symptom History
Animal Exposure History
Food Allergy History
Immunotherapy History
Other Allergy History
Participant Diary Card Record
Pre-injection Measurement for Rush immunotherapy(Histamine)
Pre-injection Measurement for Rush immunotherapy(Ragweed)
Vital Signs
SDY2: Immune Response to Varicella Vaccination in Subjects with Atopic Dermatitis Compared to Nonatopic Controls
Status: Updated
Description: This is a mechanistic, double-aim, non-randomized study that will be conducted at 2 sites, Children's Hospital Boston and National Jewish Medical and Research Center. Study participants 12 to 36 months of age with AD and without AD will be enrolled to assess immune response after varicella vaccination.

Estimated Study Duration:

The study is scheduled to be completed in 36 months. Subjects will only complete one scheduled study visit.

Study Population:

Subjects will be enrolled over a 12 month period. Subjects will be recruited at Children's Hospital Boston and National Jewish Medical and Research Center.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3G33VVU77
Subjects: 71
Study PI, contact:
NameOrganizationSite
Lynda Schneider Children's Hospital, Boston Children's Hospital Boston
Publications:None
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00406081]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 500
ELISPOT 293
Flow Cytometry 442
Clinical Assessments:
Any Adverse Event?
Any medications taken
Atopic Dermatitis Assessment
EASI Score
Family History
Medical History
Non-AD Assessment
Physical Exam
Rajka-Langeland Score
Skin exam
Skin Infection History
SDY3: Responses to Immunization with Keyhole Limpet Hemocyanin (KLH) Administered by Scarification and the Intradermal (ID) Route
Status: Updated
Description: AD is characterized by skin inflammation and recurrent skin infections. In addition, people with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH itself, may cause an immune response.

The purpose of this study is to determine the body's reaction to pure KLH in people without AD. This will be used to establish a baseline immune response and may be compared to the immune response in people with AD during future studies.

This study will last 8 weeks and will have 11 study visits. Participants in this study will be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at Visits 5 and 6.
  • Participants in Arm 1 will receive 2 immunizations each with 100 μg of KLH each.
  • Participants in Arm 2 will receive 2 immunizations through scarification (a shallow cut in the skin) with jabs, each containing 20 mg/mL of KLH. Adverse reactions will be monitored after each immunization. Once safety data from these 2 groups have been reviewed, the next 2 groups will be enrolled.
  • Participants in Arm 3 will receive 2 immunizations each with 250 μg of KLH each.
  • Participants in Arm 4 will receive 2 immunizations through scarification with 15 jabs, each containing 20mg/mL of KLH. Other study visits will include allergy testing and blood and urine collection.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3STULGP9K
Subjects: 26
Study PI, contact:
NameOrganizationSite
Henry Milgrom National Jewish Health National Jewish Health
Publications:
Response to cutaneous immunization with low-molecular-weight subunit keyhole limpet hemocyanin.. Int Arch Allergy Immunol. - 2012. doi: 10.1159/000328784. Epub 2011 Oct 28. [Pubmed: 22042247]
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00614731]
Assays:None
Clinical Assessments:
Any Adverse Event?
Any medications taken
DTH Test
DTH Test Assessment
Immunization KLH
Medical History
Physical Exam
SDY4: Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum
Status: Updated
Description: DETAILED_DESCRIPTION

AD is characterized by skin inflammation and recurrent skin infections. In addition, people with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH itself, may cause an immune response.

The purpose of this study is to determine the body's reaction to pure KLH in people without AD. This will be used to establish a baseline immune response and may be compared to the immune response in people with AD during future studies.

This study will last 8 weeks and will have 11 study visits. Participants in this study will be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at Visits 5 and 6.

  • Participants in Arm 1 will receive 2 immunizations each with 100 μg of KLH each.
  • Participants in Arm 2 will receive 2 immunizations through scarification (a shallow cut in the skin) with jabs, each containing 20 mg/mL of KLH. Adverse reactions will be monitored after each immunization. Once safety data from these 2 groups have been reviewed, the next 2 groups will be enrolled.
  • Participants in Arm 3 will receive 2 immunizations each with 250 μg of KLH each.
  • Participants in Arm 4 will receive 2 immunizations through scarification with 15 jabs, each containing 20mg/mL of KLH. Other study visits will include allergy testing and blood and urine collection.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M398H5TAXP
Subjects: 235
Study PI, contact:
NameOrganizationSite
Thomas Bieber The University of Bonn, Germany The University of Bonn, Germany
Publications:
Atopic dermo-respiratory syndrome is a correlate of eczema herpeticum.. Allergy. Jul 2011. doi: 10.1111/j.1398-9995.2010.02538.x. Epub 2011 Jan 24. [Pubmed: 21255038]
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00438022]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 3500
Clinical Assessments:
AD Assessment
Any Adverse Event?
Clinical variant of AD
EASI Score
Eczema herpeticum evaluation
Family History
Medical History
Onset of AD and evolution
Physical Exam
Question about medications taken
Rajka-Langeland Score
Severity Scoring of Atopic Dermatitis
SDY5: Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects with Atopic Dermatitis and Psoriasis
Status: Updated
Description: People with AD or psoriasis are very sensitive to skin infections and inflammations. A group of small proteins known as cathelicidins are known to be responsible for immune defense against such infections. People with AD or psoriasis seem to be missing these proteins from their skin.

The purpose of this study is to determine if the amount of cathelicidins and other small proteins in saliva is a predictor for the amount found in the skin. This is a single visit observational study. People with AD or psoriasis, as well as healthy participants, are being recruited for this study. Participants will provide a detailed medical history and undergo a physical examination. In addition, saliva and blood collection, and skin punch biopsies will be performed.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3KLK90P9T
Subjects: 85
Study PI, contact:
NameOrganizationSite
Richard Gallo University of California at San Diego University of California at San Diego
Publications:None
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00407979]
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00789880]
Assays:None
Clinical Assessments:
Any Adverse Event?
Any medications taken
Medical History
Physical Exam
Psoriasis Area and Severity Index
Rajka-Langeland Score
Skin exam
Skin lesion involved and skin lesion duration
Smoking Status
SDY6: ADVN Biomarker Registry Study
Status: Updated
Description: This protocol describes the development of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) Biomarker Registry Study. The proposed Registry is a database with a minimum of 1,000 subjects who have voluntarily agreed to provide medical and demographic information about themselves and their health status.

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

In addition, enrolled subjects will be asked to provide a blood sample for evaluation of biomarkers, and permission for blood sample storage to support future analyses. Provision of a blood sample for evaluation of biomarkers for future analyses will be optional for subjects under 6 years of age.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3J22ZOZM9
Subjects: 1231
Study PI, contact:
NameOrganizationSite
Lisa Beck University of Rochester Medical Center University of Rochester Medical Center
Publications:None
Resources:
NIH Reporter https://projectreporter.nih.gov/project_info_details.cfm?aid=9042233&icde=33171050]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 236
Clinical Assessments:
Affected body surface area for Atopic dermatitis subject
Allergy History
Any Adverse Event?
Any medications taken
Atopic Dermatitis Assessment
Atopic dermatitis supplemental information
CBC Panic values
Confirmation of Diagnostic Category
Current Medical History
EASI Score
Eczema Herpeticum Assessment
EV Assessment
Family History
Health Status
Initial diagnosis
Interim Medical History
Interim Skin Infection History
Medical History
Molluscum Contagiosum Assessment
Non-AD Assessment
Original Diagnosis
Physical Exam
Rajka-Langeland Score
Skin Infection History
Skin/Integument exam
Staphylococcus aureus infection history for previously enrolled subject
Staphylococcus Aureus Infection History Questionnaire
Vaccination history
SDY7: ADVN Biomarker Registry Study: CMI/Ab-Vaccinia Substudy
Status: Updated
Description: To measure total and specific antibody titers and T cell responses in a sample of subjects who experienced eczema vaccinatum (EV) and a group of subjects who did not suffer from EV (normal controls or healthy AD subjects).
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3G81PA5G7
Subjects: 90
Study PI, contact:
NameOrganizationSite
Donald Leung National Jewish Health National Jewish Health
Publications:None
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00550316]
Assays:None
Clinical Assessments:
Any Adverse Event?
EASI Score
Family History
Interim Medical History
Interim Skin Infection History
Medical History
Physical Exam
Question about medications taken
Rajka-Langeland Score
Skin/Integument exam
Smallpox vaccination status
Vaccination history
SDY8: ADVN Biomarker Registry Study: CMI-HSV Substudy
Status: Updated
Description: To evaluate AD subjects cell mediated immunity CMI responses to Herpes simplex virus.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3GCZX3F7X
Subjects: 67
Study PI, contact:
NameOrganizationSite
Donald Leung National Jewish Health National Jewish Health
Publications:None
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00550316]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 251
ELISPOT 64
Clinical Assessments:
Any Adverse Event?
EASI Score
Family History
Interim Medical History
Interim Skin Infection History
Medical History
Physical Exam
Question about medications taken
Rajka-Langeland Score
Skin Infection History
Skin/Integument exam
Vaccination history
SDY9: ADVN Biomarker Registry: Neutrophil Substudy
Status: Updated
Description: To evaluate the chemotactic function of peripheral blood leukocytes such as neutrophils in subjects with ADEH+, ADEH-, and NA controls.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3OP2QB064
Subjects: 62
Study PI, contact:
NameOrganizationSite
Lisa Beck University of Rochester Medical Center University of Rochester Medical Center
Publications:None
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00550316]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 64
Flow Cytometry 490
Clinical Assessments:
Any Adverse Event?
Any medications taken?
EASI Score
Family History
Interim Medical History
Interim Skin Infection History
Medical History
Physical Exam
Rajka-Langeland Score Assessment
Skin Infection History
Skin/Integument exam
Vaccination and Viral History
SDY10: Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus
Status: Updated
Description: AD is a chronic inflammatory skin disease characterized by frequent viral skin infections. Recent studies have found that components in the skin of people with AD may block AMP expression. AMPs are responsible for preventing infection from viruses.

The purpose of this study is to examine small pox virus replication and AMP expression in the skin of patients with AD as well as identify other antiviral molecules involved in immune response. These findings will be compared with those of people with psoriasis or asthma, or healthy individuals. This study will consist of one study visit at which skin and blood samples will be taken.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3K0GCB4KL
Subjects: 292
Study PI, contact:
NameOrganizationSite
Donald Leung National Jewish Health National Jewish Health
Publications:
Vaccinia virus-specific molecular signature in atopic dermatitis skin.. J Allergy Clin Immunol. Jan 2010. doi: 10.1016/j.jaci.2009.10.024. [Pubmed: 20109744]
The signal transducer and activator of transcription 6 gene (STAT6) increases the propensity of patients with atopic dermatitis toward disseminated viral skin infections.. J Allergy Clin Immunol. Nov 2011. doi: 10.1016/j.jaci.2011.06.003. Epub 2011 Jul 18. [Pubmed: 21762972]
Resources:
ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/study/NCT00407069]
Assays:None
Clinical Assessments:
Any Adverse Event?
Any Concomitant Medications
Medical History
Physical Exam
Rajka-Langeland Score
Skin/Integument exam
SDY13: Analysis of the Response of Subjects with Atopic Dermatitis to Oral Vitamin D3 by Measurement of Antimicrobial Peptide Expression in Skin and Saliva
Status: Updated
Description: The goal of the Atopic Dermatitis Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) patients from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations.

A critical host defense defect uncovered in patients with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions. AMPs are important effectors and triggers in the innate immune system, and the lack of expression in AD patients could be a key component in their susceptibility to EV.

This study will examine whether or not administration of oral Vitamin D3 given over 21 days will change the AMP expression in the skin or saliva of AD subjects and healthy controls.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3LARLT608
Subjects: 90
Study PI, contact:
NameOrganizationSite
Donald Leung National Jewish Health National Jewish Health
Jon Hanifin Oregon Health & Science University Oregon Health & Science University
Richard Gallo University of California at San Diego University of California at San Diego
Publications:None
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00789880]
Assays:None
Clinical Assessments:
Any Adverse Event?
Any medications taken
Atopic Dermatitis Assessment
EASI Score
Family History
Fitzpatrick skin scale assessment
Medical History
Non-AD Assessment
Physical/Oral Exam
Rajka-Langeland Score
Skin exam
Skin lesion Involved and skin lesion duration
Smoking Status
Vital sign
SDY14: Antimicrobial Response to Oral Vitamin D3 in Patients with Psoriasis
Status: Updated
Description: The goal of the Atopic Dermatitis and Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) subjects from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations.

A critical host defense defect uncovered in subjects with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions. AMPs are important effectors and triggers in the innate immune system, and the lack of expression of these peptides in AD patients could be a key component in their susceptibility to EV.

The main Vitamin D3 study will examine whether or not the administration of oral Vitamin D3 over 21 days will change the AMP expression in the skin and saliva of AD subjects and healthy controls. Many new avenues of research are also being explored in this subject population and require initial exploratory data to be collected to assess their potential.

As an addition to the Antimicrobial Response to Oral Vitamin D protocol, this substudy protocol will provide further control information on psoriatic responses to oral vitamin D; information on bacterial colonization in AD, non-AD, and psoriatic subjects; and assess tape stripping as a noninvasive method for the measurement of cathelicidin skin expression.
Program/Contract:
ProgramContract
Atopic Dermatitis & Vaccinia Network (ADVN) Atopic Dermatitis and Vaccinia Network (ADVN) Clinical Studies Consort-26629c
DOI: 10.21430/M3U5ABTPCJ
Subjects: 62
Study PI, contact:
NameOrganizationSite
Richard Gallo University of California at San Diego University of California at San Diego
Publications:
A randomized controlled double-blind investigation of the effects of vitamin D dietary supplementation in subjects with atopic dermatitis.. J Eur Acad Dermatol Venereol. Jun 2014. doi: 10.1111/jdv.12176. Epub 2013 May 3. [Pubmed: 23638978]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/study/NCT00789880]
Assays:None
Clinical Assessments:
Any Adverse Event?
Any medications taken
Atopic Dermatitis Assessment
EASI Score
Family History
Fitzpatrick skin scale assessment
Medical History
Non-AD Assessment
Physical/Oral Exam
Psoriasis Area and Severity Index
Rajka-Langeland Score
Skin exam
Skin lesion Involved and skin lesion duration
Smoking Status
Vital sign
SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine
Status: Updated
Description: Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3I44H8R17
Subjects: 46
Study PI, contact:
NameOrganizationSite
A. Karolina Palucka Baylor Reasearch Institute Baylor Reasearch Institute
Publications:
Systems scale interactive exploration reveals quantitative and qualitative differences in response to influenza and pneumococcal vaccines.. Immunity. Apr 2013. doi: 10.1016/j.immuni.2012.12.008. [Pubmed: 23601689]
Resources:
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE30101]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 542
Flow Cytometry 2208
Hemagglutination Inhibition 66
Luminex xMAP 229
Nanostring 18
Transcription profiling by array 161
Virus Neutralization 89
Clinical Assessments:None
SDY218: Oral Immunotherapy for Childhood Egg Allergy
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.. N Engl J Med. Jul 2012. doi: 10.1056/NEJMoa1200435. [Pubmed: 22808958]
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
SDY364: Systems Biology Approach to Study Influenza Vaccine 2012-13 in Healthy Children (see companion studies SDY144, SDY368, SDY387)
Status: Updated
Description: The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3U11KLQFF
Subjects: 23
Study PI, contact:
NameOrganizationSite
OCTAVIO RAMILO NATIONWIDE CHILDREN'S HOSPITAL NATIONWIDE CHILDREN'S HOSPITAL
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 79
Flow Cytometry 348
Hemagglutination Inhibition 92
Virus Neutralization 138
Clinical Assessments:
Medical History
Vaccination History
Vital Signs
SDY368: Systems Biology Approach to Study Influenza Vaccine 2013-14 in Healthy Children (see companion studies SDY364, SDY144, SDY387)
Status: Updated
Description: The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M3VUYLMJSR
Subjects: 22
Study PI, contact:
NameOrganizationSite
OCTAVIO RAMILO NATIONWIDE CHILDREN'S HOSPITAL NATIONWIDE CHILDREN'S HOSPITAL
Publications:None
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 87
Flow Cytometry 352
Hemagglutination Inhibition 132
Virus Neutralization 132
Clinical Assessments:
Medical History
Vaccination History
Vital Signs
SDY387: Systems Biology Approach to Study Influenza Vaccine 2010-11 in Healthy Children (see companion studies SDY144, SDY368, SDY387)
Status: Updated
Description: The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Systems Analysis Vaccine Responses in Healthy and Hyporesponsive Humans
DOI: 10.21430/M34N2JOQQM
Subjects: 22
Study PI, contact:
NameOrganizationSite
Octavio Ramilo Nationwide Children's Hospital Nationwide Children's Hospital
Publications:
Induction of ICOS+CXCR3+CXCR5+ TH cells correlates with antibody responses to influenza vaccination.. Sci Transl Med. Mar 2013. doi: 10.1126/scitranslmed.3005191. [Pubmed: 23486778]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 80
Flow Cytometry 195
Hemagglutination Inhibition 40
Virus Neutralization 120
Clinical Assessments:
Medical History
Vaccination History
Vital Signs
SDY465: Exploring the human maternal microbiome and its contribution to preterm birth
Status: Updated
Description: Preterm births occur in 12 percent of pregnancies. Preterm infants are at risk for long term health problems such as impaired hearing and vision, cerebral palsy and developmental delays. This study will characterize the human maternal microbiome and host response profiles associated with term and preterm births and identify features of each that are predicitive of preterm labor and delivery
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M3D491LGDT
Subjects: 47
Study PI, contact:
NameOrganizationSite
David Relman March of Dimes Prematurity Research Center at Stanford University School of Medicine March of Dimes Prematurity Research Center at Stanford University School of Medicine
Publications:
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:
March of Dimes Prematurity Research Center at Stanford University http://prematurity.stanford.edu/]
Stanford University R Markdown http://statweb.stanford.edu/~susan/papers/PNASRR.html.]
Assays:
Assay TypeNumber of Exp. Samples
16S rRNA gene sequencing 4122
Clinical Assessments:
Maternal_Health_and_Pregnancy_Status
SDY475: Characterization of the human maternal immune response 6 months or greater post delivery via cytometry Time-of-Flight(CyTOF).
Status: Updated
Description: Preterm births occur in 12 percent of pregnancies. Preterm infants are at risk for long term health problems such as impaired hearing and vision, cerebral palsy and developmental delays. This study will characterize the human maternal preterm birth immune system using Cytometry-Time-of-Flight analysis of whole blood
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M3D8CS7ILY
Subjects: 23
Study PI, contact:
NameOrganizationSite
Martin Angst March of Dimes Prematurity Research Center at Stanford University School of Medicine March of Dimes Prematurity Research Center at Stanford University School of Medicine
Publications:
Implementing Mass Cytometry at the Bedside to Study the Immunological Basis of Human Diseases: Distinctive Immune Features in Patients with a History of Term or Preterm Birth.. Cytometry A. Sep 2015. doi: 10.1002/cyto.a.22720. Epub 2015 Jul 17. [Pubmed: 26190063]
Resources:
March of Dimes Prematurity Research Center at Stanford University http://prematurity.stanford.edu/]
Cytobank https://www.cytobank.org/cytobank/experiments/44738]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 95
Clinical Assessments:
Medical History
Medication History
Obstetric History
Study Session
SDY660: LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis
Status: Updated
Description: ITN032AD: Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms).
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3SFPACKA3
Subjects: 640
Study PI, contact:
NameOrganizationSite
Gideon Lack King's College London Immune Tolerance Network
Publications:
Identifying infants at high risk of peanut allergy: the Learning Early About Peanut Allergy (LEAP) screening study.. J Allergy Clin Immunol. Jan 2013. doi: 10.1016/j.jaci.2012.09.015. Epub 2012 Nov 19. [Pubmed: 23174658]
Randomized trial of peanut consumption in infants at risk for peanut allergy.. N Engl J Med. Feb 2015. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23. [Pubmed: 25705822]
Effect of Avoidance on Peanut Allergy after Early Peanut Consumption.. N Engl J Med. Apr 2016. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4. [Pubmed: 26942922]
Impact of peanut consumption in the LEAP Study: Feasibility, growth, and nutrition.. J Allergy Clin Immunol. Oct 2016. doi: 10.1016/j.jaci.2016.04.016. Epub 2016 Jun 10. [Pubmed: 27297994]
Resources:
LEAP Study Information Website http://www.leapstudy.co.uk/]
Immune Tolerance Network Trialshare https://www.itntrialshare.org]
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00329784]
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01366846]
Assays:None
Clinical Assessments:
Allergy Skin Prick Test
Dust
Peanut Challenge Outcome at end of LEAP
SDY691: HLA and KIR Haplotype Sequencing
Status: Updated
Description: Assay development for complete HLA and KIR haplotype sequencing from cell lines
Program/Contract:
ProgramContract
HLA Region Genetics in Immune-mediated Diseases II Insights into immune-related disease born from population genomics
DOI: 10.21430/M3RES1FXTG
Subjects: 97
Study PI, contact:
NameOrganizationSite
Paul Norman Stanford Stanford
Publications:
Defining KIR and HLA Class I Genotypes at Highest Resolution via High-Throughput Sequencing.. Am J Hum Genet. Aug 2016. doi: 10.1016/j.ajhg.2016.06.023. [Pubmed: 27486779]
Sequences of 95 human MHC haplotypes reveal extreme coding variation in genes other than highly polymorphic HLA class I and II.. Genome Res. Mar 2017. doi: 10.1101/gr.213538.116. [Epub ahead of print] [Pubmed: 28360230]
Resources:
NCBI BioProject https://www.ncbi.nlm.nih.gov/bioproject/?term=PRJEB6763]
GitHub https://github.com/n0rmski/projectH]
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 290
Clinical Assessments:None
SDY939: Pathologically expanded peripheral B cell-helper T cells in Rheumatoid Arthritis
Status: Updated
Description: CD4+ T cells are central mediators of autoimmune pathology; however,
Program/Contract:
ProgramContract
PROSET-HD Profiling of Cell Subsets in Human Disease PROSET-HD Profiling of Cell Subsets in Human Disease
DOI: 10.21430/M3OLBPJIB1
Subjects: 4
Study PI, contact:
NameOrganizationSite
Michael Brenner Division of Rheumatology, Immunology, and Allergy, Brigham and Womens Hospital and Harvard Medical School Brigham and Women's Hospital
Publications:
Pathologically expanded peripheral T helper cell subset drives B cells in rheumatoid arthritis.. Nature. Feb 2017. doi: 10.1038/nature20810. [Pubmed: 28150777]
Resources:
Brigham and Women's Hospital http://brighamandwomens.org]
NCBI GEO https://ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE80253]
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 64
Clinical Assessments:
Clinical Disease Activity Index (CDAI)
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