DR32 DataRelease
Release Date: 09/12/2019
| SDY1086: Responses to Inactivated Influenza Vaccine (IIV) in adults with or without antibiotics | |||||||||||||||||||||||
| Status: | New | ||||||||||||||||||||||
| Description: | Single center, open mechanistic study in which subjects will be randomized to receive IIV per label at day 4 of a 5 day course of a specific antibiotic regimen (Group A) or IIV alone (Group B). Blood samples for immunologic testing will be collected at screening (from D -21 to D -1), on D0 (at vaccination), D1, D3, D7 (+/- 1 day), D30 (+/- 5 days), D90 (+/-14 days), D180 (+-/14 days), D365 (+/-28 days) post vaccination for both groups to study innate and/or adaptive immune responses. Stool samples will be collected in both groups at screening (from D - 21 to D -1), on vaccination (D0), D1, D3, D7 (+/- 1 day) and D30 (+/- 5 days), D90 (+/-14 days), D180 (+/-14 days), D365 (+/- 28 days) to study the gut microbiome in both groups. For Group A, additional visit on D-6 to D-3 will occur with stool and blood samples collection. Study will be conducted outside the 2014-2015 and 2015-2016 influenza seasons.Antibiotics received by Group A will be started 3 days prior to vaccination (D-3) and continued on day of vaccination (D0) and for one day after vaccination (D1) for a total of 5 days a) Flagyl 500 mg po tid b) Vancocin 125 mg po qid c) Neomycin sulfate 500mg po tid. The dosage of each antibiotic is taken from their respective package inserts and does not exceed the maximum dose allowed for each antibiotic. The antibiotic regimen is a broad spectrum regimen covering all types of fecal flora (anaerobes, gram positive, and gram negative bacteria); has a good safety record; has poor systemic absorption for part of the regimen (Vancocin and Neomycin sulfate ); and part of the regimen is used to treat Clostridium difficile infections (Vancocin and Flagyl). Subjects in Group A are asked to avoid all ethanol and any ethanol- containing drugs while taking antibiotics and for 48h before and after taking the antibiotics. | ||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3GEIUPY7R | ||||||||||||||||||||||
| Subjects: | 34 | ||||||||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||||||||
| SDY1464: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 2014 | |||||||
| Status: | New | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
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| DOI: | 10.21430/M3AUKDIXFI | ||||||
| Subjects: | 26 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1467: B-cell Immunity to Influenza SLVP017 2009 | |||||||
| Status: | New | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
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| DOI: | 10.21430/M3BNBGK39S | ||||||
| Subjects: | 51 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1485: Subcutaneous Immunotherapy for Mouse in Adults (SCITMO/ICAC-26) | |||||||
| Status: | New | ||||||
| Description: | This study is an open label multi-site trial of mouse allergenic extract administered by subcutaneous injection in approximately 10 - 12 adults ages 18 to 55 years with asthma. The study will be based on a continuous treatment schedule with mouse allergenic extract for a period of approximately 24 weeks. It is primarily designed to study the safety of this therapy. There will be a Screening Visit followed by a Dose Initiation Visit, at which the subject will receive their first injection. Up to 2 doses of SCIT will be given weekly during dose escalation, separated by a minimum of 2 days. Dose escalation will occur over a minimum of 11 weeks. Dose escalation can be delayed at any point if there are excessive large local reactions or other concerns, although to continue on to maintenance each subject will need to reach the maintenance dose in a maximum of 18 weeks. Once the maintenance dose is achieved, bi-weekly visits will continue to complete a total of 24 weeks of treatment. Blood will be collected at baseline and then monthly for assessment of biomarkers of allergen immunotherapy, including mouse specific IgE, IgG, IgG4, and inhibition of mouse antigen binding to B-cells. Mouse skin testing will be performed at screening. | ||||||
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| DOI: | 10.21430/M3XNRU4K3V | ||||||
| Subjects: | 50 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1486: Development of a Comprehensive Antibody Staining Database using a Standardized Analytics Pipeline | |||||||
| Status: | New | ||||||
| Description: | The goal of this study was to apply a standardized CyTOF workflow and analysis pipeline in conjunction with the Biolegend Legendscreen kit to comprehensively screen surface protein expression patterns across all major defined immune cell subsets in peripheral blood and to evaluate the impact of fixation on these expression patterns | ||||||
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| DOI: | 10.21430/M3THZOC0FS | ||||||
| Subjects: | 3 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1521: Memory B Cells with cross-reactive Abs to fluA(H1-H3) | |||||||
| Status: | New | ||||||
| Description: | To understand how the humoral immune system generates and matures protective responses to influenza virus infections and vaccinations. The group isolated B membory single cell clones from three unrelated, adult donors post TIV-vaccination, characterized the cross-reacting Abs to fluA (H1-H3) antigens, and generated the VDJ lineage tree of Bmem clones from one donor. The lineage and crystal structure analysis showed that members of a lineage had a BCR structure similar to that of a previously described Ab, encoded by different gene segments. Comparison showed that both Abs contacted the HA receptor-binding site through long heavy-chain third complementarity determining regions (HCDR3). Affinities of the clonal-lineage BCRs for historical influenza-virus HAs from both group 1 (H1) and group 2 (H3) viruses suggested that serial responses to seasonal influenza exposures had elicited the lineage and driven affinity maturation. | ||||||
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| DOI: | 10.21430/M3VTDIBF4T | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1522: Longitudinal study to common vaccines | ||||||||||
| Status: | New | |||||||||
| Description: | Goal: To understand the longevity of humoral immune protection and the role played by memory B cells after common vaccinations. To quantify the heterogeneity in antibody responses to different vaccines and viruses. To quantify the time to loss of protective immunity to each vaccine or virus at the population level. Methods: Performed longitudinal data analysis on antibody titers for viral antigens (vaccinia, measles, mumps, rubella, varicella-zoster virus, and Epstein-Barr virus) and nonreplicating antigens (tetanus and diphtheria) in 45 subjects for a period of up to 26 years. Used a mixed-effects modeling framework to characterize the heterogeneity in antibody responses and to determine how variation in the magnitude and decay rate affect how protective immunity is lost at the population level to different virus and vaccine antigens. Results: Antiviral antibody responses were remarkably stable, with half-lives ranging from an estimated 50 years for varicella-zoster virus to more than 200 years for other viruses such as measles and mumps. Antibody responses against tetanus and diphtheria antigens waned more quickly, with estimated half-lives of 11 years and 19 years, respectively. B-cell memory was long-lived, but there was no significant correlation between peripheral memory B-cell numbers and antibody levels for five of the eight antigens tested. The statistical analysis and models helped to stratify the heterogenity factors and quantified each in a single plot to view interplays of factors, such as the fast-decay of anti-nonreplicating-antigens is compensated for by the higher magnitude of responses (relative to the level for protection) which explains a higher fraction of vaccinated individuals have protective immunity to tetanus and diphtheria than to measles, rubella, and vaccinia in the first 4 decades, suggesting the need for reevaluation of their boosting schedules. | |||||||||
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| DOI: | 10.21430/M3F210A2MA | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY1528: Preeclampsia Study | |||||||
| Status: | New | ||||||
| Description: | Preeclampsia is one of the most severe pregnancy complications and a leading cause of maternal death. However, early diagnosis of preeclampsia remains a clinical challenge, only limited information of select immune cell subsets is available. The goal is to detect characteristic immune dysfunctions in the maternal blood prior to the clinical onset of preeclampsia. The study used a high-dimensional mass cytometry immunoassay to characterize the dynamic changes of over 370 immune cell features in maternal blood during healthy and preeclamptic pregnancies. Results: A set of eight cell-specific immune features that accurately predict the preeclampsia well before the clinical diagnosis is identified. Several features recapitulated previously known immune dysfunctions in preeclampsia, such as elevated pro-inflammatory innate immune responses early in pregnancy and impaired regulatory T (Treg) cell signaling. The analysis revealed additional novel immune responses that were strongly associated with, and preceded the onset of preeclampsia, notably abnormal STAT5ab signaling dynamics in CD4+T cell subsets (AUC 0.92, p = 8.0E-5). These results provide a global readout of the dynamics of the maternal immune system early in pregnancy and lay the groundwork for identifying clinically-relevant immune dysfunctions for the prediction and prevention of preeclampsia | ||||||
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| DOI: | 10.21430/M32422NUZU | ||||||
| Subjects: | 23 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1529: Transcriptional profiling of yellow fever vaccine-naive participants bafore and after vaccination against yellow fever. | |||||||
| Status: | New | ||||||
| Description: | Post-vaccination transcriptomic profiling at days 3, 7, 14 and 84 and other immune parameters have been investigated in association with the immune response, at day 80 post-vaccination, to Yellow Fever vaccine (YF-17D) in a cohort of 36 participants recruited in Entebee (Uganda). | ||||||
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| DOI: | 10.21430/M36X4BH892 | ||||||
| Subjects: | 36 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling | |||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||
| Description: | Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models | ||||||||||||||||||||||||
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| DOI: | 10.21430/M3OYWCJHO1 | ||||||||||||||||||||||||
| Subjects: | 159 | ||||||||||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||||||||||
| SDY887: Defective signaling in aging, influenza vaccination 2007 SLVP015 | |||||||
| Status: | Updated | ||||||
| Description: | Pilot year. Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 10 young (20-30 years) and 19 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||
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| DOI: | 10.21430/M33JMYFLF1 | ||||||
| Subjects: | 29 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY888: Human Immune Signature of Dengue virus infection- Gene Expression of CD4 subsets | |||||||||
| Status: | Updated | ||||||||
| Description: | The human Immune Signature of Dengue virus infection was studied in two endemic areas. T cell responses were compared in infected patients and uninfected individuals also from Dengue endemic areas. | ||||||||
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| DOI: | 10.21430/M3C4L4WD2Z | ||||||||
| Subjects: | 102 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY1025: Asthma Phenotypes in the Inner City (APIC/ICAC-19) | ||||||||||||
| Status: | Updated | |||||||||||
| 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. | |||||||||||
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| DOI: | 10.21430/M39SEUM79K | |||||||||||
| Subjects: | 717 | |||||||||||
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| Assays: | None | |||||||||||
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| SDY1026: Biomarkers of Cockroach Sublingual Immunotherapy 2 (BioCSI 2/ICAC-17) | |||||||
| Status: | Updated | ||||||
| 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 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1027: The Role of Epigenetics in Inner City Asthma (ICAC-15) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | The study is designed to determine the relation between methylation of CpG motifs and asthma in children residing in the inner city. | ||||||||||||
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| DOI: | 10.21430/M3SXDBHQTS | ||||||||||||
| Subjects: | 200 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY1028: Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE/ICAC-20) | ||||||||||
| Status: | Updated | |||||||||
| 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. | |||||||||
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| DOI: | 10.21430/M3HZZOS3Y5 | |||||||||
| Subjects: | 513 | |||||||||
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| Assays: | None | |||||||||
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