DR27 DataRelease
Release Date: 07/03/2018
SDY1260: Correlation between human innate and adaptive immune responses to T-cell independent or dependent meningococcal vaccines. | |||||||
Status: | New | ||||||
Description: | Thirty healthy adults (18-45 years of age) with no history of prior meningococcal vaccination and no contraindications to immunization will be vaccinated using either the meningococcal conjugate vaccine (MCV) or the meningococcal non-conjugate polysaccharide vaccine (MPSV). The study will be conducted as a randomized double blinded trial. Vaccine administration will be performed by an unblinded vaccine administrator, who will not be involved in subsequent assessments. Blood samples will be collected on Days D0 (at enrollment) and D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immunity markers. Even though meningococcal vaccination is considered safe, volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. | ||||||
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DOI: | 10.21430/M3F47KSLLP | ||||||
Subjects: | 30 | ||||||
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Clinical Assessments: | None |
SDY1264: Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans | |||||||
Status: | New | ||||||
Description: | A major challenge in vaccinology is to prospectively determine vaccine efficacy. Here we have used a systems biology approach to identify early gene signatures that predicted immune responses in humans vaccinated with yellow fever vaccine YF-17D. Vaccination induced genes that regulate virus innate sensing and type I interferon production. Computational analyses identified a gene signature, including complement protein C1qB and eukaryotic translation initiation factor 2 alpha kinase 4 an orchestrator of the integrated stress response that correlated with and predicted YF-17D CD8+ T cell responses with up to 90% accuracy in an independent, blinded trial. A distinct signature, including B cell growth factor TNFRS17, predicted the neutralizing antibody response with up to 100% accuracy. These data highlight the utility of systems biology approaches in predicting vaccine efficacy. | ||||||
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DOI: | 10.21430/M3XTBR8F18 | ||||||
Subjects: | 25 | ||||||
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Clinical Assessments: | None |
SDY1276: Time series of global gene expression after trivalent influenza vaccination in humans | |||||||||
Status: | New | ||||||||
Description: | The relationship between gene expression patterns and humoral immune response to vaccination was analyzed in order to understand the interindividual variability among immune reponse to vaccination | ||||||||
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DOI: | 10.21430/M3J92GN8I3 | ||||||||
Subjects: | 226 | ||||||||
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Clinical Assessments: | None |
SDY1289: YFV integrated mulitlineage and polyfunctional responses | |||||||
Status: | New | ||||||
Description: | Correlates of immune-mediated protection to most viral and cancer vaccines are still unknown. This impedes the development of novel vaccines to incurable diseases such as HIV and cancer. In this study, we have used functional genomics and polychromatic flow cytometry to define the signature of the immune response to the yellow fever (YF) vaccine 17D (YF17D) in a cohort of 40 volunteers followed for up to 1 yr after vaccination. We show that immunization with YF17D leads to an integrated immune response that includes several effector arms of innate immunity, including complement, the inflammasome, and interferons, as well as adaptive immunity as shown by an early T cell response followed by a brisk and variable B cell response. Development of these responses is preceded, as demonstrated in three independent vaccination trials and in a novel in vitro system of primary immune responses (modular immune in vitro construct [MIMIC] system), by the coordinated up-regulation of transcripts for specific transcription factors, including STAT1, IRF7, and ETS2, which are upstream of the different effector arms of the immune response. These results clearly show that the immune response to a strong vaccine is preceded by coordinated induction of master transcription factors that lead to the development of a broad, polyfunctional, and persistent immune response that integrates all effector cells of the immune system. peripheral blood samples from human newborns | ||||||
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DOI: | 10.21430/M37CO9E6FQ | ||||||
Subjects: | 30 | ||||||
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Clinical Assessments: | None |
SDY1293: Expression of genes associated with immunoproteasome processing of major histocompatibility complex peptides is indicative of protection with adjuvanted RTS,S malaria vaccine. | |||||||
Status: | New | ||||||
Description: | Background. Patterns of expressed genes in the peripheral blood mononuclear cells of persons who were receiving RTS,S/AS01 or RTS,S/AS02 malaria vaccine and were undergoing experimental challenge with mosquito-borne falciparum malaria were examined to identify markers associated with protection. | ||||||
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DOI: | 10.21430/M3ETOL8TGS | ||||||
Subjects: | 58 | ||||||
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Clinical Assessments: | None |
SDY1299: Identification of Three Rheumatoid Arthritis Disease Subtypes By Machine Learning Integration of Synovial Histologic Features and RNA Sequencing Data | |||||||
Status: | New | ||||||
Description: | Gene expression analysis of RA and OA synovial tissue revealed 3 distinct synovial subtypes. These labels were used to generate a histologic scoring algorithm in which the histologic scores were found to be associated with parameters of systemic inflammation, including the erythrocyte sedimentation rate, CRP levels, and autoantibody levels. Comparison of gene expression patterns to clinical features revealed a potentially clinically important distinction: mechanisms of pain may differ in patients with different synovial subtypes. | ||||||
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DOI: | 10.21430/M3V2G6PBYS | ||||||
Subjects: | 45 | ||||||
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SDY1328: Transcriptional profiling of HBV-naive subjects before vaccination against Hepatitis A/B viruses, Diphtheria/Tetanus toxoids and Cholera. | |||||||
Status: | New | ||||||
Description: | Mechanisms of poor responses to vaccines remain unknown. Hepatitis B virus-naive elderly subjects received three vaccines, including a vaccine against hepatitis B virus (HBV). Pre-vaccination high dimensional analyses of blood using transcriptional profiling and flow cytometry revealed that subjects having increased memory B cell frequencies and higher expression of genes downstream of B cell receptor signaling responded more strongly to the HBV vaccine whereas subjects having higher expression of inflammatory related genes and greater numbers of activated innate immune cells showed a weaker response to this vaccine. The heme-induced response was associated with the poor response to the hepatitis B vaccine. Transcriptional profiling and flow cytometry results were validated in a distinct set of elderly subjects with accuracy greater than 60%. Our study is the first that identifies baseline predictors of responses to vaccines in a population of subjects known to be highly susceptible to infections. | ||||||
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DOI: | 10.21430/M3ID8ZC1AT | ||||||
Subjects: | 174 | ||||||
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Clinical Assessments: | None |
SDY1337: Sequence-based HLA-A, B, C, DP, DQ, and DR typing | |||||||
Status: | New | ||||||
Description: | DNA sequence-based typing at the HLA-A, -B, -C, -DPB1, -DQA1, -DQB1, and -DRB1 loci | ||||||
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DOI: | 10.21430/M3M9Y78QLF | ||||||
Subjects: | 339 | ||||||
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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 |
SDY74: Systems Biology Approach to Analysis of 2010-11 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY301, SDY296) | |||||||
Status: | Updated | ||||||
Description: | This study will measure the immune response to the influenza vaccine The long-term goal is to develop improved vaccines to infectious diseases such as influenza. Blood will be collected from patients at several visits before and after vaccination. The blood will be used in a series of immunological tests to measure the strength and breadth of immune response. These assays may include T cell and B cell activation assays, microarray testing, Epimax, Epigen, and flow cytometry. | ||||||
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DOI: | 10.21430/M3EJ72RVRG | ||||||
Subjects: | 12 | ||||||
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SDY89: Systems Biology Analysis of the response to Licensed Hepatitis B Vaccine (Engerix-B) (see companion study SDY690) | |||||||||
Status: | Updated | ||||||||
Description: | This project will contribute to the overall vision and goals of this U19 by analyzing the role of adjuvants in the humoral response to hep B vaccination in healthy individuals. | ||||||||
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DOI: | 10.21430/M3AYWX8NOT | ||||||||
Subjects: | 50 | ||||||||
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Clinical Assessments: | None |
SDY91: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE ITN021AI) | |||||||||||
Status: | Updated | ||||||||||
Description: | Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA). The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit. Participants will then be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit. |
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DOI: | 10.21430/M3TK42R0QR | ||||||||||
Subjects: | 197 | ||||||||||
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SDY111: VZV vaccination in the elderly | |||||||||||||
Status: | Updated | ||||||||||||
Description: | Healthy adults (50+ years old) with history of varicella but no history of zoster are vaccinated with Zostavax. Blood and serum are taken prior to vaccination and at several points after. A systems biology approach will be used to identify age-related decreases in immune function and potential predictors and correlates of protection. | ||||||||||||
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DOI: | 10.21430/M3ODYABDL2 | ||||||||||||
Subjects: | 48 | ||||||||||||
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Clinical Assessments: | None |
SDY144: Systems Biology Approach to Study Influenza Vaccine 2011-12 in Healthy Children (see companion studies SDY364, 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. The assay results from SDY144's EXP13603, EXP11769, and EXP13604 are the same as for this study. The difference is how the floe cytometry results were analyzed in this study versus SDY144. |
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DOI: | 10.21430/M3ANETOJEC | ||||||||||
Subjects: | 17 | ||||||||||
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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 |
SDY183: Effect of age on 2008/2009 trivalent influenza vaccine response | |||||||
Status: | Updated | ||||||
Description: | To comprehensively compare the humoral immune response of young (20-31 years old) to older human subjects (60 to >90 years old) following vaccination with seasonal flu vaccine. We generated a peptide microarray featuring tiled peptides with sequences derived from the hemagglutinin proteins of multiple influenza strains. We probed the microarrays with pre- and post-vaccination serum from each age group. Serum antibody reactivity to the microarray peptides was quantified using fluorescently labeled anti-human secondary antibodies and a fluorescent microarray scanner. | ||||||
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DOI: | 10.21430/M37TU3LVTU | ||||||
Subjects: | 76 | ||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY296: Systems Biology Approach to Analysis of 2011-12 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY74, SDY301) | |||||||||||||||
Status: | Updated | ||||||||||||||
Description: | This project will contribute to the overall vision and goals of this U19 by analyzing the immune response to Flu vaccination in healthy individuals. The knowledge generated in this Project will be transferred to Projects 3-5 where immune effects of vaccination will be studied in patients with underlying immune system alterations. | ||||||||||||||
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DOI: | 10.21430/M300RMFHZQ | ||||||||||||||
Subjects: | 45 | ||||||||||||||
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Publications: | None | ||||||||||||||
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SDY299: Systems Biology Analysis of the response to Licensed Hepatitis B Vaccine (HEPLISAV) in Whole Blood (see companion studies SDY816 and SDY690) | |||||||
Status: | Updated | ||||||
Description: | This project will contribute to the overall vision and goals of this U19 by analyzing the role of adjuvants in the humoral response to hep B vaccination in healthy individuals. | ||||||
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DOI: | 10.21430/M34QI37OT9 | ||||||
Subjects: | 25 | ||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY300: Healthy Human DC and monocyte subsets transcriptional regulations in response to Fluzone 2010-2011 and pneumococcal vaccinations | |||||||
Status: | Updated | ||||||
Description: | The described experiments in this study were designed to deconvolute the molecular signature observed in the whole blood of healthy subsets at early time points following the administration of Fluzone 2010-2011 vaccines. RNA-seq data generated from sorted purified cell populations, including mDC and monocyte subsets will permit us to reveal distinct roles that DC and monocyte subsets play in eliciting immune responses to vaccines against flu in healthy adults using system biology approaches. | ||||||
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DOI: | 10.21430/M3FJJ9G9ZZ | ||||||
Subjects: | 10 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY301: Systems Biology Approach to Analysis of 2012-13 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY74, SDY296) | |||||||||||||||
Status: | Updated | ||||||||||||||
Description: | This project will contribute to the overall vision and goals of this U19 by analyzing the immune response to Flu vaccination in healthy individuals. The knowledge generated in this Project will be transferred to Projects 3-5 where immune effects of vaccination will be studied in patients with underlying immune system alterations. | ||||||||||||||
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DOI: | 10.21430/M3T0BGMGGC | ||||||||||||||
Subjects: | 40 | ||||||||||||||
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Publications: | None | ||||||||||||||
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SDY311: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2010 (See companion studies SDY315 2012 / SDY312 2009 / SDY314 2008 / SDY112 2011) | |||||||||||||
Status: | Updated | ||||||||||||
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/M33MSDRJ55 | ||||||||||||
Subjects: | 76 | ||||||||||||
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Publications: | None | ||||||||||||
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Clinical Assessments: | None |
SDY312: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2009 (See companion studies SDY315 2012 / SDY314 2008 / SDY311 2010 / SDY112 2011) | |||||||||||
Status: | Updated | ||||||||||
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/M3G230OYOM | ||||||||||
Subjects: | 84 | ||||||||||
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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. | ||||||||||
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DOI: | 10.21430/M3U11KLQFF | ||||||||||
Subjects: | 23 | ||||||||||
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Publications: | None | ||||||||||
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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. | ||||||||||
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DOI: | 10.21430/M3VUYLMJSR | ||||||||||
Subjects: | 22 | ||||||||||
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Publications: | None | ||||||||||
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SDY369: Systems Biology Approach to Study Influenza Vaccine in Children with Autoimmunity (Juvenile Dermatomyositis JDM) 2011/2012 Cohort (see companion studies SDY376, SDY372, SDY645) | |||||||||||
Status: | Updated | ||||||||||
Description: | This Project will study vaccine responses in healthy and sick children. It will address the following questions: 1) which are the best biomarkers of protective immune response to influenza vaccine in healthy children; 2) how unique autoimmune backgrounds set the stage for responsiveness/unresponsiveness to vaccines; 3) whether vaccination contributes to increase the breadth of autoimmunity in a disease-specific manner. Ultimately, we expect that these studies will shed light on basic aspects of humoral immune responses to vaccines and will permit us to discover biomarkers of response that can be applied to healthy children and to the general population. | ||||||||||
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DOI: | 10.21430/M38SIW861C | ||||||||||
Subjects: | 4 | ||||||||||
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Publications: | None | ||||||||||
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SDY372: Systems Biology Approach to Study Influenza Vaccine in Children with Autoimmunity (Juvenile Dermatomyositis JDM) 2012/2013 Cohort (see companion studies (SDY369, SDY376, SDY645) | |||||||||||
Status: | Updated | ||||||||||
Description: | This Project will study vaccine responses in healthy and sick children. It will address the following questions: 1) which are the best biomarkers of protective immune response to influenza vaccine in healthy children; 2) how unique autoimmune backgrounds set the stage for responsiveness/unresponsiveness to vaccines; 3) whether vaccination contributes to increase the breadth of autoimmunity in a disease-specific manner. Ultimately, we expect that these studies will shed light on basic aspects of humoral immune responses to vaccines and will permit us to discover biomarkers of response that can be applied to healthy children and to the general population. | ||||||||||
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DOI: | 10.21430/M3NOD39G06 | ||||||||||
Subjects: | 19 | ||||||||||
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Publications: | None | ||||||||||
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SDY376: Systems Biology Approach to Study Influenza Vaccine in Children with Autoimmunity (Juvenile Dermatomyositis JDM) 2013/2014 Cohort (see companion studies SDY369, SDY372, SDY645) | |||||||||||
Status: | Updated | ||||||||||
Description: | This Project will study vaccine responses in healthy and sick children. It will address the following questions: 1) which are the best biomarkers of protective immune response to influenza vaccine in healthy children; 2) how unique autoimmune backgrounds set the stage for responsiveness/unresponsiveness to vaccines; 3) whether vaccination contributes to increase the breadth of autoimmunity in a disease-specific manner. Ultimately, we expect that these studies will shed light on basic aspects of humoral immune responses to vaccines and will permit us to discover biomarkers of response that can be applied to healthy children and to the general population. | ||||||||||
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DOI: | 10.21430/M37IMDD0RO | ||||||||||
Subjects: | 13 | ||||||||||
Study PI, contact: |
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Publications: | None | ||||||||||
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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: |
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DOI: | 10.21430/M34N2JOQQM | ||||||||||
Subjects: | 22 | ||||||||||
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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 | ||||||
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DOI: | 10.21430/M3D491LGDT | ||||||
Subjects: | 47 | ||||||
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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: | 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: |
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DOI: | 10.21430/M3XZMA3XL4 | ||||||||||
Subjects: | 20 | ||||||||||
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SDY597: DC transcriptomics in response to vaccines | |||||||
Status: | Updated | ||||||
Description: | The mechanisms by which microbial vaccines interact with human APCs remain elusive. | ||||||
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DOI: | 10.21430/M3AC1WMBDO | ||||||
Subjects: | 20 | ||||||
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Clinical Assessments: | None |
SDY614: Mayo Clinic Smallpox Vaccine Immunogenetics Replication Study | |||||||||||||||
Status: | Updated | ||||||||||||||
Description: | Smallpox Vaccine Immunogenetics | ||||||||||||||
Program/Contract: |
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DOI: | 10.21430/M3EEL6ILMK | ||||||||||||||
Subjects: | 1061 | ||||||||||||||
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SDY622: Humoral responses to Influenza vaccination in aged populations - Year 2 2012 (See companion studies SDY272 2011, SDY648 2013, SDY739 2014, SDY819 2015) | |||||||||||
Status: | Updated | ||||||||||
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 | ||||||||||
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Clinical Assessments: | None |
SDY645: Systems Biology Approach to Study Influenza Vaccine in Children with Autoimmunity (Juvenile Dermatomyositis JDM) 2014/2015 Cohort (see companion studies SDY369, SDY376, SDY372) | |||||||||||
Status: | Updated | ||||||||||
Description: | This Project will study vaccine responses in healthy and sick children. It will address the following questions: 1) which are the best biomarkers of protective immune response to influenza vaccine in healthy children; 2) how unique autoimmune backgrounds set the stage for responsiveness/unresponsiveness to vaccines; 3) whether vaccination contributes to increase the breadth of autoimmunity in a disease-specific manner. Ultimately, we expect that these studies will shed light on basic aspects of humoral immune responses to vaccines and will permit us to discover biomarkers of response that can be applied to healthy children and to the general population. | ||||||||||
Program/Contract: |
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DOI: | 10.21430/M35HMSDTHH | ||||||||||
Subjects: | 11 | ||||||||||
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Publications: | None | ||||||||||
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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: | Updated | ||||||||||
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 | ||||||||||
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Clinical Assessments: | None |
SDY667: The immune signature of palmoplantar pustulosis | |||||||
Status: | Updated | ||||||
Description: | This study will compare adult patients with CPP(chronic plaque type psoriasis ), who are currently not undergoing topical, systemic or biologic treatment and matched healthy controls. Baseline demographics and psoriasis history will be recorded. All PPP patients will be comprehensively phenotyped and psoriasis severity assessed including the body surface area (BSA) involved, Psoriasis Area and Severity Index (PASI), Physicians Global assessment (PGA) and Dermatology Life Quality Index (DLQI). | ||||||
Program/Contract: |
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DOI: | 10.21430/M34NBAVDGJ | ||||||
Subjects: | 50 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
SDY670: Molecular Profiling of Donor and Recipient Proinflammatory and Allograft Response (CTOT-03) | |||||||
Status: | Updated | ||||||
Description: | Inflammation and injuries to transplanted organs during the immediate post-operative period may be linked to early organ dysfunction and higher rates of transplant rejection in the recipient. Currently, mRNA expression of proinflammatory genes in donor tissues is thought to be a risk factor for early organ transplant dysfunction, increased expression of the recipients cell-mediated immunity genes, and organ rejection. The purpose of this study is to test the association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in kidney, lung, and liver transplant recipients. This study will also test the effects of proinflammatory mediators expressed in the transplanted organ pre- and post-reperfusion on organ rejection and genes expressed in cell mediated immune responses. This will be achieved by identifying the proinflammatory immune responses and their mechanisms. | ||||||
Program/Contract: |
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DOI: | 10.21430/M3GLG1R2NY | ||||||
Subjects: | 311 | ||||||
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SDY673: Characterization of maternal serum gene expression and microbiome | |||||||||
Status: | Updated | ||||||||
Description: | Plasma cell-free RNA (cfRNA) encompasses a broad spectrum of RNA species that can be derived from both human cells and microbes. Because cfRNA is fragmented and of low concentration, it has been challenging to profile its transcriptome using standard RNA-seq methods. This study assessed several recent RNA-seq methods on cfRNA samples to analyze the dynamic changes of both the human transcriptome and the microbiome of plasma during pregnancy. cfRNA reflected a well-orchestrated immune modulation during pregnancy: an up-regulation of anti-inflammatory genes and an increased abundance of anti-microbial genes, while the plasma microbiome remained relatively stable during pregnancy. The bacteria Ureaplasma shows an increased prevalence and increased abundance at postpartum, which is likely to be associated with postpartum infection. This study demonstrated that cfRNA-seq can be used to detect a number of human pathogens, including high loads of human parvovirus B19 virus (B19V), known to be a potential cause of complications in pregnancy. | ||||||||
Program/Contract: |
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DOI: | 10.21430/M3OARGGSY0 | ||||||||
Subjects: | 50 | ||||||||
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Clinical Assessments: | None |
SDY690: Systems Biology Study to Investigate Immune Correlates to Hepatitis B Vaccine Engerix-B comparing cellular responses and gene expression patterns between PBMCs (cell sorts) and whole blood samples (see companion studies SDY816 and SDY299) | |||||||
Status: | Updated | ||||||
Description: | This project will contribute to the overall vision and goals of this U19 by analyzing the role of adjuvants in the humoral response to hep B vaccination in healthy individuals. | ||||||
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DOI: | 10.21430/M3F8W7VA7O | ||||||
Subjects: | 12 | ||||||
Study PI, contact: |
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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: | Updated | ||||||||||
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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Clinical Assessments: | None |
SDY753: Investigating Alterations to the Nasal Microbiome after Vaccination with LAIV | |||||||
Status: | Updated | ||||||
Description: | The goal of this proposal is to characterize alterations to the nasal microbiome after vaccination with the 2012-2013 seasonal LAIV and to correlate these changes with LAIV-specific immune responses (A/California/7/2009 (H1N1) and A/Victoria/361/2011 (H3N2)). | ||||||
Program/Contract: |
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DOI: | 10.21430/M3ENN2D3SZ | ||||||
Subjects: | 47 | ||||||
Study PI, contact: |
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Publications: | None | ||||||
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Clinical Assessments: | None |
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 | ||||||
Program/Contract: |
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DOI: | 10.21430/M3PZM1ERD2 | ||||||
Subjects: | 7 | ||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY816: Systems Biology Analysis of the response to Licensed Hepatitis B Vaccine (HEPLISAV) in specific cell subsets (see companion studies SDY299 and SDY690) | |||||||
Status: | Updated | ||||||
Description: | None | ||||||
Program/Contract: |
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DOI: | 10.21430/M3HV9NRS67 | ||||||
Subjects: | 10 | ||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY839: Measles Immunity | |||||||||
Status: | Updated | ||||||||
Description: | None | ||||||||
Program/Contract: |
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DOI: | 10.21430/M3XWLPC8A2 | ||||||||
Subjects: | 2681 | ||||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY1164: Vaginal microbial signature for preterm birth | |||||||
Status: | Updated | ||||||
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. | ||||||
Program/Contract: |
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DOI: | 10.21430/M37W3869AH | ||||||
Subjects: | 136 | ||||||
Study PI, contact: |
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SDY1175: Human microbiome characterization through massive shotgun sequencing of circulating cell-free DNA. | |||||||
Status: | Updated | ||||||
Description: | Cell-free DNA-derived microbiomes of 1,351 samples from 188 patients in four longitudinally sampled cohorts were analyzed. The majority of assembled sequences from cfDNA are derived from previously unidentified organisms, for instance numerous novel anelloviruses in immunocompromised patients, which represent a doubling of identified members in that viral family. Over two thirds of the sequences are bacterial, and the majority are most similar to proteobacteria; however, many large contigs can only be classified at the phylum or superkingdom level. Numerous novel phages were also found throughout the population. Multiple independent analyses confirm the existence of these novel sequences. | ||||||
Program/Contract: |
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DOI: | 10.21430/M33PSZ2FHV | ||||||
Subjects: | 16 | ||||||
Study PI, contact: |
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Clinical Assessments: | None |
SDY1206: Early pregnancy vaginal microbiome trends and preterm birth (see companion study SDY1341) | ||||||||||
Status: | Updated | |||||||||
Description: | Previous studies have shown that vaginal microbiota of asymptomatic, nonpregnant, reproductive age women cluster into 5 distinct ?community-state types?, which differ both by dominant Lactobacillus species as well as overall community composition. A much greater proportion of African-American and Hispanic women harbored a non-Lactobacillus-dominant community, suggesting that in some women a non-Lactobacillus-based vaginal community may be a normal variant. A recent study examined vaginal microbial composition and the risk for preterm birth but had very few African-American subjects and few preterm births. This study characterizes vaginal microbial community characteristics over time in a large predominantly African-American cohort of pregnant women and test whether particular community characteristics are associated with the risk for subsequent preterm birth. | |||||||||
Program/Contract: |
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DOI: | 10.21430/M3H1U3KJMZ | |||||||||
Subjects: | 77 | |||||||||
Study PI, contact: |
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