DR23 DataRelease
Release Date: 09/29/2017
SDY15: Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis | |||||||||
Status: | New | ||||||||
Description: | The main objective of the Atopic Dermatitis and Vaccinia Network (ADVN) is to reduce the risk of eczema vaccinatum (EV) following smallpox vaccination. Since direct vaccination of atopic dermatitis (AD) subjects with live vaccinia virus (VV) is contraindicated due to the heightened risk of EV, a surrogate virus, yellow fever (YF) (the highly attenuated vaccine strain, 17D), was chosen. This is a live virus that can be administered transcutaneously (TC) with a bifurcated needle in a manner analogous to smallpox vaccination. In this study, AD subjects and controls will be vaccinated with the yellow fever virus (YFV) (YFV-17D) by the subcutaneous (SC) or TC route to determine: 1) whether there are quantitative differences in the antiviral immune responses elicited in these 2 distinct groups of subjects; and 2) whether the route of vaccination alters these immune responses, especially in AD subjects who may have altered cutaneous immunity. Using in-depth analysis of both innate and adaptive immunity in AD subjects and controls, an immunological signature may be identified that would aid in the screening process of individuals who might be at risk for EV. Moreover, this study will provide substantial information about normal and defective cutaneous immunity in AD subjects, which will be critical for future development of therapeutic drugs aimed at preventing or alleviating EV, as well as other more common viral skin infections. | ||||||||
Program/Contract: |
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DOI: | 10.21430/M3KTJ8SA7A | ||||||||
Subjects: | 82 | ||||||||
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SDY49: Analysis of STAT mediated dendritic cell activation mechanisms with different stimuli. | |||||||
Status: | New | ||||||
Description: | Cells isolated from healthy subjects are used for the in vitro analysis of STAT mediated dendritic cell activation with different stimuli. This is preformed by measuring cell responses to interleukin or other treatments with or without siRNA inhibition of signaling pathways mediating dendritic cell maturation. Analysis of DC responses is measured with flow cytometry, siRNA inhibition, QPCR and western blots. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3S5MWVVTL | ||||||
Subjects: | 2 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY50: Measuring the Activation Kinetics of Signaling Pathways in virus infected or cytokine treated dendritic cells. | |||||||
Status: | New | ||||||
Description: | Analysis of the activation kinetics of signaling pathways involved with dendritic cell maturation. Analysis of activation measured by the treatment of cells with cytokines, cytokine/receptor antagonists or infection with NDV, SeV or PR8 influenza. Assay methods include flow cytometry, imaging flow cytometry, ELISA, qPCR and Western blot. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3TLD5BC4S | ||||||
Subjects: | 2 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY194: Innate Immune Pathways in Elderly and Immunosuppressed Populations 2011 | |||||||||
Status: | New | ||||||||
Description: | Innate Immune Pathways in Elderly and Immunosuppressed Populations | ||||||||
Program/Contract: |
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DOI: | 10.21430/M32GW683ZT | ||||||||
Subjects: | 120 | ||||||||
Study PI, contact: |
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Publications: | None | ||||||||
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Clinical Assessments: | None |
SDY272: Humoral responses to Influenza vaccination in aged populations - Year 1 2011 (See companion studies SDY622 2012, SDY648 2013, SDY739 2014, SDY819 2015) | |||||||||
Status: | New | ||||||||
Description: | The purpose of this study was to measure the antibody responses to the Trivalent Inactivated influenza Vaccine(TIV) in young and aged subjects | ||||||||
Program/Contract: |
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DOI: | 10.21430/M3T9X2TDBK | ||||||||
Subjects: | 46 | ||||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY350: Mouse Study of X31 Influenza Infection | |||||||
Status: | New | ||||||
Description: | Influenza primary infection study with murine subject | ||||||
Program/Contract: |
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DOI: | 10.21430/M3LO7MV28O | ||||||
Subjects: | 37 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY396: Immune Responses to Seasonal LAIV 2011-2012 Influenza Vaccination in Humans (see companion study SDY224,SDY564) | |||||||||||
Status: | New | ||||||||||
Description: | To use system biology approaches to compare differences in immune responses to vaccine | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M3S7UQFBVS | ||||||||||
Subjects: | 18 | ||||||||||
Study PI, contact: |
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Publications: | None | ||||||||||
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Clinical Assessments: | None |
SDY564: Immune Responses to Seasonal TIV 2012-2013 Influenza Vaccination in Humans (see companion study SDY396,SDY224) | |||||||||||
Status: | New | ||||||||||
Description: | To use system biology approaches to compare differences in immune responses to vaccine | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M3ZLPC4WQZ | ||||||||||
Subjects: | 10 | ||||||||||
Study PI, contact: |
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Publications: | None | ||||||||||
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Clinical Assessments: | None |
SDY583: Immune Responses to Seasonal Influenza Vaccination in Mouse model | ||||||||||
Status: | New | |||||||||
Description: | Seasonal influenza vaccine study with Murine subject | |||||||||
Program/Contract: |
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DOI: | 10.21430/M3FUNSCZCK | |||||||||
Subjects: | 66 | |||||||||
Study PI, contact: |
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Publications: | None | |||||||||
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Clinical Assessments: | None |
SDY585: 2013 Murine Vaccine with Adjuvant Study | |||||||
Status: | New | ||||||
Description: | Study of Influenza vaccine coupled with adjuvant in Murine model | ||||||
Program/Contract: |
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DOI: | 10.21430/M3I8W54C3M | ||||||
Subjects: | 36 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY591: Cdiff32 | |||||||
Status: | New | ||||||
Description: | 20 to 25-week old WT mice will be infected with 10^7 cfu/mouse of C. difficile by orogastric gavage. A control uninfected group will be included. The C difficile strain to use is VPI10463 (ATCC 43255). | ||||||
Program/Contract: |
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DOI: | 10.21430/M3T1G3YFSX | ||||||
Subjects: | 48 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY618: ADRN Influenza Vaccine Pilot (ADRN-03) | |||||||
Status: | New | ||||||
Description: | This is a single center, open-label, mechanistic study designed to determine the variance of the antibody response in non-atopic and ADEH- participants receiving a single dose of the 2011-2012 seasonal Fluzone Intradermal vaccine administered per label. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3AFZ310EE | ||||||
Subjects: | 40 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
Resources: |
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Assays: | None | ||||||
Clinical Assessments: | None |
SDY619: ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04) | |||||||
Status: | New | ||||||
Description: | Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections. The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections. The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin. | ||||||
Program/Contract: |
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DOI: | 10.21430/M384Z5ZXPI | ||||||
Subjects: | 150 | ||||||
Study PI, contact: |
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Publications: |
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Assays: | None | ||||||
Clinical Assessments: | None |
SDY620: Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study (ADRN-05) | |||||||
Status: | New | ||||||
Description: | This is a multi-site, randomized, open label, mechanistic study designed to compare the immune response in non-atopic and AD participants receiving a single dose of the 2012-2013 seasonal Fluzone Intradermal vaccine administered per label. A secondary objective is to compare the immune response of AD participants receiving intradermal influenza vaccination to the response of AD participants receiving intramuscular influenza vaccination. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3UT5M218G | ||||||
Subjects: | 368 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: | None | ||||||
Clinical Assessments: | None |
SDY622: Humoral responses to Influenza vaccination in aged populations - Year 2 2012 (See companion studies SDY272 2011, SDY648 2013, SDY739 2014, SDY819 2015) | |||||||||||
Status: | New | ||||||||||
Description: | The purpose of this study was to measure the B cell responses to the Trivalent Inactivated influenza Vaccine(TIV) in young and aged subjects, and measure their different B cell subsets. | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M34F1R11OM | ||||||||||
Subjects: | 63 | ||||||||||
Study PI, contact: |
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Assays: |
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Clinical Assessments: | None |
SDY648: Humoral responses to Influenza vaccination in aged populations - Year 3 2013 (See companion studies SDY272 2011, SDY622 2012, SDY739 2014, SDY819 2015) | |||||||||||
Status: | New | ||||||||||
Description: | The purpose of this study was to measure the B celland T cell responses to the Trivalent Inactivated influenza Vaccine(TIV) in young and aged subjects, and measure their different B cell subsets. | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M3E3VOEDY2 | ||||||||||
Subjects: | 63 | ||||||||||
Study PI, contact: |
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Assays: |
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Clinical Assessments: | None |
SDY739: Humoral responses to Influenza vaccination in aged populations - Year 4 2014 (See companion studies SDY272 2011, SDY622 2012, SDY648 2013, SDY819 2015) | |||||||||||
Status: | New | ||||||||||
Description: | The purpose of this study was to measure the B celland T cell responses to the Trivalent Inactivated influenza Vaccine(TIV) in young and aged subjects, and measure their different B cell subsets. | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M352VU0YNY | ||||||||||
Subjects: | 65 | ||||||||||
Study PI, contact: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY746: Innate Immune Pathways in Elderly and Immunosuppressed Populations 2012 | |||||||
Status: | New | ||||||
Description: | Innate Immune Pathways in Elderly and Immunosuppressed Populations | ||||||
Program/Contract: |
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DOI: | 10.21430/M3E3ZNTJ56 | ||||||
Subjects: | 115 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY819: Humoral responses to Influenza vaccination in aged populations - Year 5 2015 (See companion studies SDY272 2011, SDY622 2012, SDY648 2013, SDY739 2014) | ||||||||||
Status: | New | |||||||||
Description: | The purpose of this study was to measure the B cell and T cell responses to the Trivalent Inactivated influenza Vaccine(TIV) in young and aged subjects, and measure their different B cell subsets. | |||||||||
Program/Contract: |
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DOI: | 10.21430/M39Y58SSCH | |||||||||
Subjects: | 45 | |||||||||
Study PI, contact: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY873: Modeling Viral Immunity and Antagonism in Dendritic Cells | |||||||
Status: | New | ||||||
Description: | A suite of ex vivo perturbations are applied to explore DC response | ||||||
Program/Contract: |
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DOI: | 10.21430/M3EXEMMV8M | ||||||
Subjects: | 93 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Assays: |
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Clinical Assessments: | None |
SDY901: Activation of the PD-1 Pathway Contributes to Immune Escape in EGFR-Driven Lung Tumors | |||||||
Status: | New | ||||||
Description: | The success in lung cancer therapy with Programmed Death (PD)-1 blockade suggests that immune escape mechanisms contribute to lung tumor pathogenesis. We identified a correlation between Epidermal Growth Factor Receptor (EGFR) pathway activation and a signature of immunosuppression manifested by upregulation of PD-1, PD-L1, cytotoxic T lymphocyte antigen-4 (CTLA-4), and multiple tumor-promoting inflammatory cytokines. We observed decreased cytotoxic T cells and increased markers of T cell exhaustion in mouse models of EGFR-driven lung cancer. PD-1 antibody blockade improved the survival of mice with EGFR-driven adenocarcinomas by enhancing effector T cell function and lowering the levels of tumor promoting cytokines. Expression of mutant EGFR in bronchial epithelial cells induced PD-L1, and PD-L1 expression was reduced by EGFR inhibitors in non-small cell lung cancer cell lines with activated EGFR. These data suggest that oncogenic EGFR signaling remodels the tumor microenvironment to trigger immune escape, and mechanistically link treatment response to PD-1 inhibition. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3VRA7INN8 | ||||||
Subjects: | 8 | ||||||
Study PI, contact: |
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Publications: |
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Assays: |
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Clinical Assessments: | None |
SDY1025: APIC | ||||||||||||
Status: | New | |||||||||||
Description: | This study looks to define the phenotypic characteristics of Difficult-to-Treat asthma, among 650 children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis. | |||||||||||
Program/Contract: |
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DOI: | 10.21430/M39SEUM79K | |||||||||||
Subjects: | 717 | |||||||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: | None | |||||||||||
Clinical Assessments: |
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SDY1026: BioCSI 2 (Biomarkers of Cockroach Sublingual Immunotherapy 2) | |||||||
Status: | New | ||||||
Description: | This study looks to compare two doses of glycerinated German cockroach allergenic extract versus placebo administered via the sublingual route in 99 children ages 5 to 17 years with perennial allergic rhinitis, asthma, or both. It is designed to study biomarkers of the immune response to allergen immunotherapy as well as the safety of this therapy. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3LVUFRQOA | ||||||
Subjects: | 99 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: | None | ||||||
Clinical Assessments: | None |
SDY1027: Epigenetics | |||||||||||||
Status: | New | ||||||||||||
Description: | The study is designed to determine the relation between methylation of CpG motifs and asthma in children residing in the inner city. | ||||||||||||
Program/Contract: |
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DOI: | 10.21430/M3SXDBHQTS | ||||||||||||
Subjects: | 200 | ||||||||||||
Study PI, contact: |
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Assays: |
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Clinical Assessments: | None |
SDY1028: Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE) | ||||||||||
Status: | New | |||||||||
Description: | A three-armed prospective randomized double-blind placebo-controlled trial investigating the efficacy of standard care plus 4-5 months of treatment with (a) a boost of inhaled corticosteroid therapy Flovent Diskus (fluticasone) versus (b) Xolair(omalizumab) or (c) placebo Xolair (omalizumab) and placebo Flovent Diskus (fluticasone) in reducing the exacerbations during the fall season. | |||||||||
Program/Contract: |
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DOI: | 10.21430/M3HZZOS3Y5 | |||||||||
Subjects: | 513 | |||||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: | None | |||||||||
Clinical Assessments: |
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SDY1029: SCITCO (Subcutaneous Immunotherapy for Cockroach) | |||||||
Status: | New | ||||||
Description: | This is an open label single site trial of German cockroach allergenic extract administered by subcutaneous injection in 10 adults ages 18 to 55 years with perennial allergic rhinitis, asthma, or both. It is designed to study biomarkers of the immune response to allergen immunotherapy as well as the safety of this therapy. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3XJ80W9FK | ||||||
Subjects: | 11 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: | None | ||||||
Clinical Assessments: | None |
SDY1100: Project 3 - Optimization experiments DCs DV2 and DV4 - CyTOF | |||||||
Status: | New | ||||||
Description: | Ex vivo infections of human monocyte derived DCs DENV2 and DENV4 analysis were performed to study the innate immune profile upon infection with those viruses using CyTOF and to elucidate the appropiated time points for future experiments. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3JDEIXF26 | ||||||
Subjects: | 7 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1108: Systemic Immunity for Cancer Immunotherapy | |||||||||||||
Status: | New | ||||||||||||
Description: | A systems approach reveals that engagement of systemic immunity is critical to the process of tumor rejection following immunotherapy. Using a spontaneous model of triple-negative breast cancer, we assessed immune cell dynamics across the organism during tumor rejection | ||||||||||||
Program/Contract: |
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DOI: | 10.21430/M3L410EFMQ | ||||||||||||
Subjects: | 13 | ||||||||||||
Study PI, contact: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1115: Comparative analysis of neonatal and adult immune responses after in vitro rhinovirus stimulation | |||||||
Status: | New | ||||||
Description: | Rhinovirus infections during infancy account for the majority of respiratory illness health care utilization and are an associated risk factor for subsequent development of allergic asthma. Neonatal type I interferon production is diminished compared to adults after stimulation with TLR agonists. However, broad profiling of immune cell responses to infectious rhinovirus has not been undertaken and we hypothesized that additional immune differences can be identified in neonates. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3IR2J7XWW | ||||||
Subjects: | 17 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1149: Project 3 - Optimization experiments DCs DV2 and DV4 - MBAA | |||||||
Status: | New | ||||||
Description: | Ex vivo infections of human monocyte derived DCs DENV2 (16681) and DENV4 (Indonesia/1976/1036) analysis were performed to study the innate immune profile upon infection usin a multiplexed beads array assay (MBAA) with those viruses and to elucidate the appropiated time points for future experiments. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3C546VF92 | ||||||
Subjects: | 7 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1152: Phosphorylation profiles of ERK, p38, MAPKs in DCs in response to different pathogenic stimuli | |||||||
Status: | New | ||||||
Description: | 2 different stimuli were used to activated DCs LPS and Curdlan. A time course experiment was conducted for 2 hr to measure the phosphorylation profiles of MAPKs, ERK1/2 and p38. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3N3RFL2E5 | ||||||
Subjects: | 2 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1153: Induction of maturation Marker after combinatorial TNFa and IFNb treatment | |||||||
Status: | New | ||||||
Description: | Explore combinatorial TNFa and IFNb treatment of DCs | ||||||
Program/Contract: |
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DOI: | 10.21430/M35IWA4GOQ | ||||||
Subjects: | 2 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1154: siRNA knock down of RIG-I and TBK1 in DCs | |||||||
Status: | New | ||||||
Description: | DCs were transfected with RIG-I or TBK1 targeting siRNA and infected with NDV 24h post-transfectio | ||||||
Program/Contract: |
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DOI: | 10.21430/M3WMFFH6SY | ||||||
Subjects: | 2 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
Resources: |
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Assays: |
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Clinical Assessments: | None |
SDY1155: RNA-Seq and miRNA-Seq of Human Placenta | |||||||
Status: | New | ||||||
Description: | RNA sequencing was performed with the primary goal of discovering key placental villous trophoblast(VT) and decidual basalis(DB) transcripts differentially expressed in intra-amniotic infection (IAI)-induced pretrem birth (PTB) | ||||||
Program/Contract: |
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DOI: | 10.21430/M34I5YT3K9 | ||||||
Subjects: | 15 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: |
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Clinical Assessments: |
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SDY1157: Immune response throughout human pregnancy | |||||||
Status: | New | ||||||
Description: | The phenotype and intracellular signaling activities of all major innate and adaptive immune cells were simultaneously quantified in serial whole-blood samples throughout pregnancy. Three sets of data were generated by quantifying the abundances of peripheral immune cell sub-sets, capturing endogenous intracellular signaling activities, and determining the capacity of immune cell subsets to respond to stimulation with receptor-specific ligands. The csEN algorithm was adapted from the Elastic Net (EN) regularized regression method and accounts for the influence of previous biological knowledge of receptor-specific signal transduction on the generation of single-cell mass cytometry data. This algorithm allowed to infer a model of interrelated immune features that accurately predicts the timing of immunological adaptations over the entire course of a term pregnancy. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3OV4WX72N | ||||||
Subjects: | 28 | ||||||
Study PI, contact: |
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Publications: |
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Resources: |
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Assays: |
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Clinical Assessments: |
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SDY1164: Vaginal microbial signature for preterm birth | |||||||
Status: | New | ||||||
Description: | Recent studies about association between maternal vaginal microbiota and risks for preterm birth (PTB) conflicted along similar lines: Caucasian and Asian women cohorts showed associations between PTB and low Lactobacillus vaginal communities (BV-like) while no significant association with PTB was detected in cohorts of African-American women. This study compares two new larger cohorts of women at low and high risk for PTB, addressing two challenges: (i) low power resulting from the combination of small study populations (30?91 pregnant women), the many taxa measured by metabarcoding, and the absence of initial hypotheses more specific than some difference between preterm and term gestations; and (ii) insufficient understanding of population-specific factors that might modulate the PTB?microbiota association. | ||||||
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DOI: | 10.21430/M37W3869AH | ||||||
Subjects: | 136 | ||||||
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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. | ||||||||||
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DOI: | 10.21430/M3STAI2V6T | ||||||||||
Subjects: | 64 | ||||||||||
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Clinical Assessments: | None |
SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine | |||||||||||||||||
Status: | Updated | ||||||||||||||||
Description: | Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination. | ||||||||||||||||
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DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
Subjects: | 46 | ||||||||||||||||
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Clinical Assessments: | None |
SDY671: Knechtle ITN013ST: Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults | ||||||||||
Status: | Updated | |||||||||
Description: | This study will evaluate the effects of intravenous (IV) alemtuzumab and oral sirolimus and tacrolimus after kidney transplantation. The study will also evaluate this regimen's potential to allow eventual discontinuation of components of long-term immunosuppressive therapy. Study duration will be 4 years. Participants will undergo kidney transplantation on Day 0, receive IV doses of alemtuzumab, acetaminophen, and diphenhydramine on Days 0, 1, and 2, as well as methylprednisolone on Day 0. Patients will receive up to 10 days of valganciclovir or acyclovir post transplant. Daily oral doses of tacrolimus will contiue for 60 days and sirolimus daily by mouth for at least 12 months after transplant. Participants will take sulfamethoxazole-trimethoprim 3 times a week, valganciclovir or acyclovir for up to 10 days post-transplant, and clotrimazole or nystatin by mouth for at least 3 months post-transplant. Sixty-to study visits are planned to be spread out over 4 years post transplant. Sirolimus withdrawal process will occur over a minimum of 3 months at an approximate rate of 33% of the pre-withdrawal dose per month. Participants eligible for sirolimus withdrawal will undergo several kidney biopsies, including one 2 weeks prior to the start of withdrawal, 6 and 12 months after completion of withdrawal, 1 year after study enrollment, and annually thereafter. | |||||||||
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DOI: | 10.21430/M38BB6XTX9 | |||||||||
Subjects: | 20 | |||||||||
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SDY775: Evaluating differences between healthy placental microbiome and contamination control sample microbiomes | |||||||
Status: | Updated | ||||||
Description: | Placental samples from healthy deliveries were compared to an extensive set of bacterial contamination controls as well as to oral and vaginal samples from the same women. This control study was unable to distinguish bacterial species and abundance between placental and contamination control samples | ||||||
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DOI: | 10.21430/M3PZM1ERD2 | ||||||
Subjects: | 7 | ||||||
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Clinical Assessments: | None |