DR17 DataRelease
Release Date: 02/11/2016
| SDY63: Immunologic and genomic signatures of influenza vaccine response - 2010 (see companion studies SDY400, SDY404, SDY520) | |||||||
| Status: | New | ||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response. | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M38WXGBDTS | ||||||
| Subjects: | 49 | ||||||
| Study PI, contact: |
|
||||||
| Publications: | None | ||||||
| Resources: |
|
||||||
| Assays: |
|
||||||
| 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: | New | ||||||||||||||
| 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. | ||||||||||||||
| Program/Contract: |
|
||||||||||||||
| DOI: | 10.21430/M300RMFHZQ | ||||||||||||||
| Subjects: | 45 | ||||||||||||||
| Study PI, contact: |
|
||||||||||||||
| Publications: | None | ||||||||||||||
| Resources: |
|
||||||||||||||
| Assays: |
|
||||||||||||||
| Clinical Assessments: |
|
||||||||||||||
| SDY301: Systems Biology Approach to Analysis of 2012-13 TIV Fluzone Influenza Vaccine Response in Healthy Individuals (see companion studies SDY74, SDY296) | |||||||||||||||
| Status: | New | ||||||||||||||
| 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. | ||||||||||||||
| Program/Contract: |
|
||||||||||||||
| DOI: | 10.21430/M3T0BGMGGC | ||||||||||||||
| Subjects: | 40 | ||||||||||||||
| Study PI, contact: |
|
||||||||||||||
| Publications: | None | ||||||||||||||
| Resources: |
|
||||||||||||||
| Assays: |
|
||||||||||||||
| Clinical Assessments: |
|
||||||||||||||
| SDY400: Immunologic and genomic signatures of influenza vaccine response - 2012 (see companion studies SDY63, SDY404, SDY520) | |||||||
| Status: | New | ||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year3 2012 | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3U7GDOFIT | ||||||
| Subjects: | 98 | ||||||
| Study PI, contact: |
|
||||||
| Publications: | None | ||||||
| Resources: |
|
||||||
| Assays: |
|
||||||
| Clinical Assessments: | None | ||||||
| SDY404: Immunologic and genomic signatures of influenza vaccine response - 2011 (see companion studies SDY63, SDY400, SDY520) | |||||||||
| Status: | New | ||||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year2 2011 | ||||||||
| Program/Contract: |
|
||||||||
| DOI: | 10.21430/M3GWQRC8DT | ||||||||
| Subjects: | 72 | ||||||||
| Study PI, contact: |
|
||||||||
| Publications: |
|
||||||||
| Resources: |
|
||||||||
| Assays: |
|
||||||||
| Clinical Assessments: | None | ||||||||
| SDY6: ADVN Biomarker Registry Study | |||||||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||||||
| Description: | This protocol describes the development of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) Biomarker Registry Study. The proposed Registry is a database with a minimum of 1,000 subjects who have voluntarily agreed to provide medical and demographic information about themselves and their health status. These data will be collected until a minimum of 12 weeks prior to the end of the funding cycle to allow for final data entry, query resolution, and database lock and will be used to identify potential subjects for future studies designed to improve scientific understanding of the increased risk of complications after exposure to the smallpox vaccine for people with atopic dermatitis (AD). In addition, enrolled subjects will be asked to provide a blood sample for evaluation of biomarkers, and permission for blood sample storage to support future analyses. Provision of a blood sample for evaluation of biomarkers for future analyses will be optional for subjects under 6 years of age. |
||||||||||||||||||||||||||||
| Program/Contract: |
|
||||||||||||||||||||||||||||
| DOI: | 10.21430/M3J22ZOZM9 | ||||||||||||||||||||||||||||
| Subjects: | 1231 | ||||||||||||||||||||||||||||
| Study PI, contact: |
|
||||||||||||||||||||||||||||
| Publications: | None | ||||||||||||||||||||||||||||
| Resources: |
|
||||||||||||||||||||||||||||
| Assays: |
|
||||||||||||||||||||||||||||
| Clinical Assessments: |
|
||||||||||||||||||||||||||||
| SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling | |||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||
| Description: | Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models | ||||||||||||||||||||||||
| Program/Contract: |
|
||||||||||||||||||||||||
| DOI: | 10.21430/M3OYWCJHO1 | ||||||||||||||||||||||||
| Subjects: | 159 | ||||||||||||||||||||||||
| Study PI, contact: |
|
||||||||||||||||||||||||
| Publications: |
|
||||||||||||||||||||||||
| Resources: |
|
||||||||||||||||||||||||
| Assays: |
|
||||||||||||||||||||||||
| 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. | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3EJ72RVRG | ||||||
| Subjects: | 12 | ||||||
| Study PI, contact: |
|
||||||
| Publications: |
|
||||||
| Resources: |
|
||||||
| Assays: |
|
||||||
| Clinical Assessments: |
|
||||||
| 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. |
||||||||||
| Program/Contract: |
|
||||||||||
| DOI: | 10.21430/M3ANETOJEC | ||||||||||
| Subjects: | 17 | ||||||||||
| Study PI, contact: |
|
||||||||||
| Publications: |
|
||||||||||
| Resources: |
|
||||||||||
| Assays: |
|
||||||||||
| Clinical Assessments: |
|
||||||||||
| SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine | |||||||||||||||||
| Status: | Updated | ||||||||||||||||
| Description: | Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination. | ||||||||||||||||
| Program/Contract: |
|
||||||||||||||||
| DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
| Subjects: | 46 | ||||||||||||||||
| Study PI, contact: |
|
||||||||||||||||
| Publications: |
|
||||||||||||||||
| Resources: |
|
||||||||||||||||
| Assays: |
|
||||||||||||||||
| Clinical Assessments: | None | ||||||||||||||||
| SDY546: FACTOR ITN507ST: Study of Tolerant Kidney Transplant Recipients | |||||||
| Status: | Updated | ||||||
| Description: | Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the bodys immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as immunosuppressive or anti-rejection drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to tolerate the transplanted kidney, and this condition is referred to as tolerance. In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance. Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010). | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3SBI9FQPC | ||||||
| Subjects: | 96 | ||||||
| Study PI, contact: |
|
||||||
| Publications: |
|
||||||
| Resources: |
|
||||||
| Assays: |
|
||||||
| Clinical Assessments: | None | ||||||
| SDY662: WISP-R ITN029ST: Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients | |||||||
| Status: | Updated | ||||||
| Description: | Immunosuppressive drugs are prescribed to organ transplant recipients to prevent organ rejection. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from pediatric liver transplant recipents | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3QJJF9A71 | ||||||
| Subjects: | 25 | ||||||
| Study PI, contact: |
|
||||||
| Publications: |
|
||||||
| Resources: |
|
||||||
| Assays: | None | ||||||
| Clinical Assessments: |
|
||||||
| SDY668: Miller-Burke ITN022ST: Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients | |||||||
| Status: | Updated | ||||||
| Description: | Alemtuzumab is used to treat certain blood disorders. This study evaluates kidney transplant recipients treated with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3QZ1A9OOE | ||||||
| Subjects: | 9 | ||||||
| Study PI, contact: |
|
||||||
| Publications: | None | ||||||
| Resources: |
|
||||||
| Assays: | None | ||||||
| Clinical Assessments: |
|
||||||
| 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. | |||||||||
| Program/Contract: |
|
|||||||||
| DOI: | 10.21430/M38BB6XTX9 | |||||||||
| Subjects: | 20 | |||||||||
| Study PI, contact: |
|
|||||||||
| Publications: |
|
|||||||||
| Resources: |
|
|||||||||
| Assays: | None | |||||||||
| Clinical Assessments: |
|
|||||||||
| SDY674: Vincenti ITN023ST: Belatacept to Prevent Organ Rejection in Kidney Transplant Patients | |||||||
| Status: | Updated | ||||||
| Description: | Participants, at the time of transplant, begin immunosuppressive treatment with belatacept, sirolimus and thymoglobulin. Dose reduction of belatacept begins at 12 weeks post-transplant. Drug withdrawal begins at year 2. | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3W336PE8D | ||||||
| Subjects: | 10 | ||||||
| Study PI, contact: |
|
||||||
| Publications: |
|
||||||
| Resources: |
|
||||||
| Assays: | None | ||||||
| Clinical Assessments: |
|
||||||