DR19 DataRelease
Release Date: 06/20/2016
| SDY293: Live Lung Donor Retrospective Study (RELIVE-02) | |||||||
| Status: | New | ||||||
| Description: | The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis. | ||||||
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| DOI: | 10.21430/M3495BHP30 | ||||||
| Subjects: | 369 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY479: Urinary cell mRNA profiles of rejection (CTOT-04) | |||||||
| Status: | New | ||||||
| Description: | This is an observational, uncontrolled and non-randomized study in which all deceased donor and living donor kidney allograft recipients at all participating centers are eligible for enrollment. The primary aims are : (1) To investigate whether the levels of mRNA encoding cytotoxic proteins perforin and granzyme B, and T cell marker CD3, are a sensitive and specific noninvasive diagnostic test for acute rejection in renal allografts; and (2) To determine whether mRNA profiles of sequential urine specimens predict the development of rejection. We will investigate whether mRNA profiles predict kidney graft function as assessed by estimated GFR at 12, 24 and 36 months after transplantation. | ||||||
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| DOI: | 10.21430/M3YP3ROBVT | ||||||
| Subjects: | 494 | ||||||
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| SDY557: Noninvasive Monitoring in Kidney Transplantation (CTOT-01) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | This is a non randomized observational study to assess the sensitivity, specificity, and predictive value of a panel of noninvasive monitoring tests as correlates with acute rejection, graft loss, deterioration of renal function, and degree of graft fibrosis in renal allograft recipients receiving commonly used immunosuppressive regimens. | ||||||||||||
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| DOI: | 10.21430/M3OPJVGUBK | ||||||||||||
| Subjects: | 280 | ||||||||||||
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| SDY571: Observational Study of Alloimmunity in Cardiac Transplant Recipients (CTOT-05) | |||||||||||
| Status: | New | ||||||||||
| Description: | A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival. | ||||||||||
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| DOI: | 10.21430/M3AG2C6125 | ||||||||||
| Subjects: | 200 | ||||||||||
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| SDY670: Molecular Profiling of Donor and Recipient Proinflammatory and Allograft Response (CTOT-03) | |||||||
| Status: | New | ||||||
| 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. | ||||||
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| DOI: | 10.21430/M3GLG1R2NY | ||||||
| Subjects: | 311 | ||||||
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| SDY689: B-Cell depletion by anti-CD20 in renal allograft recipients who develop de novo anti-HLA alloantibodies | |||||||
| Status: | New | ||||||
| Description: | The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan, MabThera) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney. The pilot study compares the use of rituximab (Rituxan) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant. | ||||||
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| DOI: | 10.21430/M3VC8YZQ9K | ||||||
| Subjects: | 757 | ||||||
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| Publications: | None | ||||||
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| SDY788: Immune Profiles to Predict Response to Desensitization Therapy in Highly HLA-Sensitized Kidney Transplant Candidates | |||||||||
| Status: | New | ||||||||
| Description: | Single-cell mass cytometry by time-of-flight (CyTOF) phenotyping, gene arrays, and phosphoepitope flow cytometry were performed in 20 highly sensitized kidney transplant candidates undergoing desensitization therapy. | ||||||||
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| DOI: | 10.21430/M3R0UUBC6K | ||||||||
| Subjects: | 22 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY789: Temporal Response to seasonal and pandemic H1N1 infection in human DCs | |||||||
| Status: | New | ||||||
| Description: | Purpose: mRNA expression analysis of DC response to influenza viruses. Experiment variables (brief description of biological sample treatments and time points): human mDCs are infected with H1N1 influenza viruses (IAV) Brevig/1918, California/09, New Caledonia/99 and Texas/91 for 2, 2.4, 3.2, 4, 5, 6, 7 and 8 hours. RNA is isolated and hybridized to gene expression microarrays | ||||||
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| DOI: | 10.21430/M3I7TJB7L2 | ||||||
| Subjects: | 2 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY797: T1DAL ITN045AI: Inducing Remission in New Onset Type 1 Diabetes Mellitus with Alefacept(Amevive) | |||||||
| Status: | New | ||||||
| Description: | T1DM is an autoimmune disease that can emerge suddenly, causing dependence on insulin for life. This means that the immune system (the part of your body that helps fight infections) mistakenly attacks the cells in the pancreas that produce insulin (beta cells). As beta cells are destroyed, one's ability to produce insulin is decreased. Insulin helps keep blood glucose (sugar) levels normal. | ||||||
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| DOI: | 10.21430/M3F6ZX0TRG | ||||||
| Subjects: | 49 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY798: Diamond-Wofsy ITN002AI: Treating Systemic Lupus Erythematosus (SLE) Patients with CTLA4-IgG4m (RG2077) | ||||||||||
| Status: | New | |||||||||
| Description: | SLE is a chronic, inflammatory autoimmune disorder that may affect many organ systems, including the skin, joints, and internal organs. RG2077 has been studied for use in multiple sclerosis, another autoimmune disorder. This study will evaluate the safety and efficacy of RG2077 in SLE patients who are currently receiving cyclophosphamide.This trial is composed of two parts. The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 (0.2 mg/kg or 2 mg/kg); this part of the study will last 60 days. At screening, patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077. Patients will also have medical and medication history assessments, a comprehensive physical exam, and blood and urine tests. There are 5 study visits for the first part of the trial; these will occur at screening, at study entry, and Days 1, 14, and 28. Selected visits will include physical exam, vital signs measurement, blood and urine tests, and disease activity assessment. At Days 7 and 60, patients will be contacted by phone to report their medication history and any adverse effects they have experienced.The second part of the study will evaluate a single 10 mg/kg dose of RG2077; this part of the study will last 90 days. In the study, participants will be randomly assigned to one of two groups. At the start of the study, Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only. There will be 9 study visits; these will occur at study screening, study entry, and Days 1, 4, 7, 14, 28, and 60. At selected visits, patients will undergo physical exam, vital signs measurement, blood tests and urine tests, and disease activity assessment. | |||||||||
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| DOI: | 10.21430/M3PU4TFQBF | |||||||||
| Subjects: | 6 | |||||||||
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| Assays: | None | |||||||||
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| SDY816: Systems Biology Analysis of the response to Licensed Hepatitis B Vaccine (HEPLISAV) in specific cell subsets (see companion studies SDY299 and SDY690) | |||||||
| Status: | New | ||||||
| Description: | None | ||||||
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| DOI: | 10.21430/M3HV9NRS67 | ||||||
| Subjects: | 10 | ||||||
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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 | ||||||||||||||||||||||||
| 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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| 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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| SDY167: VRC304 - A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP) Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | The primary objective was to evaluate the safety and tolerability of an investigational vaccine VRC-AVIDNA036-00-VP in humans at doses 1 mg and 4 mg administered intramuscularly using a needle-free injection system. The secondary objectives included evaluation of whether VRC-AVIDNA036-00-VP (at doses 1 mg and 4 mg) induced antibodies as assessed by an HAI assay at Day 0 and Week 12. Exploratory analyses included evaluation of the immunogenicity of VRC-AVIDNA036-00-VP at doses 1 mg and 4 mg using intracellular cytokine staining, ELISpot, neutralizing antibody assay, HAI assay to H1 or H3HA or other immunological assays at time intervals between Day 0 and Week 42. | ||||||||||||
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| DOI: | 10.21430/M3SGHW16WZ | ||||||||||||
| Subjects: | 45 | ||||||||||||
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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 | ||||||||||||||||
| SDY210: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies | |||||||
| Status: | Updated | ||||||
| Description: | Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits. ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether highly sensitized, compared to weakly sensitized asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters. | ||||||
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| DOI: | 10.21430/M3I0JL7KUZ | ||||||
| Subjects: | 546 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY211: Inner-City Anti-IgE Therapy for Asthma | |||||||
| Status: | Updated | ||||||
| Description: | This study is testing a medication called omalizumab for the treatment of asthma. Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause inflammation in the lungs. Omalizumab can reduce inflammation and asthma attacks by blocking IgE. Unlike other medications for asthma, omalizumab is not an inhaler medication or pill. Instead, omalizumab is dissolved in a liquid and given by injection. Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas. The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone. This study will recruit inner-city children and adolescents with moderate to severe allergic asthma. This study will last about 1.5 to 2 years. Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks. The injection schedule will be determined based on the participant's weight and total IgE. Both groups will receive standardized specialist care and basic asthma education including environmental control measures. Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study. Participants will complete a series of questionnaires about topics including perceived stress, home environment, physical activity, diet and nutrition, smoking habits, and quality of life. At study entry and monthly throughout the study, participants will complete questionnaires about their asthma symptoms and medical resource utilization. Some visits will include a physical examination, vital signs measurement, lung function tests, asthma medication evaluation, and an asthma action plan. Blood collection is required up to eight times during the study for safety labs. | ||||||
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| DOI: | 10.21430/M3V7CAZ3NP | ||||||
| Subjects: | 419 | ||||||
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| Assays: | None | ||||||
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| SDY223: A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis | |||||||
| Status: | Updated | ||||||
| Description: | Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both. At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached. For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home. This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits. | ||||||
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| DOI: | 10.21430/M34X4ULP41 | ||||||
| Subjects: | 54 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY224: Immune Responses to Seasonal TIV 2010-2011 Influenza Vaccination in Humans (see companion study SDY396,SDY564) | |||||||||||||||
| Status: | Updated | ||||||||||||||
| Description: | High-frequency sampling combined with systems biology analysis of human peripheral blood cells following influenza vaccination was used to investigate T cell and B cell responses. Functional principal component analysis was used to examine time varying B cell vaccine response highlighting a single subject-specific mathematical pattern explaining ninety percent of the transcriptome variation. In addtition, daily sampling and monitoring of the proliferation marker Ki-67, revealed influenza-specific CD4 T cells do respond to vaccination. | ||||||||||||||
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| DOI: | 10.21430/M37KMO7JLW | ||||||||||||||
| Subjects: | 14 | ||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||
| SDY269: Systems Biology of 2008 Influenza Vaccination in Humans (See companion studies SDY61 2007 / SDY270 2009 / SDY271 Role for CaMKIV in the Regulation of Antibody Responses to Influenza Vaccine) | |||||||||||||||
| Status: | Updated | ||||||||||||||
| Description: | Using a systems biology approach to study innate and adaptive responses to influenza vaccination in humans during the 2008-2009 influenza season. | ||||||||||||||
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| DOI: | 10.21430/M3CDX6TL4I | ||||||||||||||
| Subjects: | 63 | ||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||
| SDY281: Study responses of Adult and neonatal APCs to TLR ligands | |||||||
| Status: | Updated | ||||||
| Description: | The assays in this study entail stimulation of adult and neonatal blood cells with various concentrations of defined prototype ligands for TLRs 1-9. Multiparameter flow cytometry was used to detect intracellular cytokines (TNF, IL-6, IL-10, IL-12p40, IL-12p70, and IFN-alpha) in whole blood and PBMCs. | ||||||
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| DOI: | 10.21430/M38S6PGG9Z | ||||||
| Subjects: | 80 | ||||||
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| Publications: | None | ||||||
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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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| 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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| SDY314: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2008 (See companion studies SDY315 2012 / SDY312 2009 / 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/M3WZ7XK2GG | ||||||||||||
| Subjects: | 92 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY315: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) - 2012 (See companion studies SDY311 2010 / 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/M3CJT3NCT2 | ||||||||||||
| Subjects: | 74 | ||||||||||||
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| Publications: | None | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY420: Immunobiology of Aging | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Overriding aim: To develop and make available to other investigators a comprehensive immune phenotype and functional database of a cohort of at least 700 normal healthy individuals. The dataset will comprise a cross-sectional analysis of the general population between the ages of 40 and 90+ (representing equal gender and representative ethnic population, and equal distribution by decade of life). The registry will contain demographic data, race/ethnicity, prescribed medications, over the counter medications, vitamins, alternative therapies, physical function questionnaire, alternative contact person, and HIPPA release. Fasting blood will be obtained for immune phenotyping and functional analyses. The immune profile will contain the results of both conventional and novel immune profiling assays to profile immune related phenotypic and functional changes associated with aging (using PBMC subset analysis, cytokines, and activation induced signaling of PBMCs for phosphoepitope and gene expression analyses). Data from these analyses will be useful in identifying biomarkers associated with aging, gender and/or chronic infection as well as correlation with phenotypic and functional aspects of aging such as sarcopenia and disability. The immune profile (as well as normal blood chemistries and demographic data) of these subjects will be made available to serve as the basis for future longitudinal study of change in the immune profile over time in association with the development of co-morbidities associated with aging. The primary deliverable for this proposal will be a unique open access electronic data repository that has phenotypic and functional information in multiple scales (epidemiological, and clinical, and, at the cell and molecular level, of immune phenotype) and genetic and proteomic information (gene and protein expression of resting and activated PBCs) on over 700 healthy individuals at different ages from 40 to 90 years. This resource will enable a systems-based approach to the immunology of aging. | ||||||||||
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| DOI: | 10.21430/M3WHM08QLC | ||||||||||
| Subjects: | 753 | ||||||||||
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| SDY472: Plasmablast response to inactivated and live attenuated influenza vaccines (TIV3/TIV3 ID) in 2013 | |||||||||
| Status: | Updated | ||||||||
| Description: | This study will be conducted with up to 40 generally healthy children | ||||||||
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| DOI: | 10.21430/M3KHTSSSN7 | ||||||||
| Subjects: | 24 | ||||||||
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| Publications: | None | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY478: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination - 2013 | |||||||||
| 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/M3YEJTSS29 | ||||||||
| Subjects: | 70 | ||||||||
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| Publications: | None | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY524: AbATE ITN027AI: Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes | |||||||
| Status: | Updated | ||||||
| Description: | Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time of type 1 diabetes diagnosis, 60% to 85% of the diabetic person's beta cells have already been destroyed. However, between 15% and 40% of these cells remain and are able to produce insulin. Treatment that slows the destruction of additional beta cells may be able to decrease a patient's reliance on insulin and improve their quality of life. Anti-CD3 mAb is genetically engineered and directed against the CD3 antigen on T cells; this antibody selectively attacks the immune cells responsible for beta cell destruction. In a small exploratory clinical trial, patients with newly diagnosed type 1 diabetes who received a single, 2-week treatment with anti-CD3 mAb had preserved beta cell function and significantly lower insulin requirements than untreated patients for up to two years after therapy. This study will investigate whether a second course of anti-CD3 mAb administered one year after the first administration is able to prolong or improve the effects of the biologic in people who have recently diagnosed type 1 diabetes mellitus. Participants will be randomly assigned to one of two groups. The Experimental Group will receive anti-CD3 mAb treatment plus Diabetes Standard of Care Treatment; the Active Comparator Group will receive Diabetes Standard of Care Treatment. The Experimental Group will be treated with the antibody for the first 14 days of the study and again one year later. These participants will be admitted to the hospital for the first 5 days of a treatment cycle. Participants who live within 1 hour of the hospital may receive the remainder of a treatment cycle as an outpatient, but those who live farther away will be hospitalized for 14 days. For the first treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 1, 2, 3, 6, 9, and 12. For the second treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 13, 16, 19, 21, and 24.The Active Comparator Group will have 12 study visits over two years. At study entry, all participants will receive daily iron supplementation, either as ferrous sulfate or a multivitamin with iron. Participants will be followed for up to 2 years to assess their overall diabetes health and to capture laboratory measures of beta cell and immune system function. Medication history and adverse event assessment will occur at all visits. A physical exam, vital signs measurement, and blood collection will occur at most visits. Medical history and urine collection will occur at selected visits. | ||||||
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| DOI: | 10.21430/M3YQ7O1CPL | ||||||
| Subjects: | 83 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY565: IL2-RAPA ITN018AI: Proleukin and Rapamune in Type 1 Diabetes Mellitus | |||||||
| Status: | Updated | ||||||
| Description: | At the time of diagnosis, type 1 diabetes patients have 15-40 percent of their beta cells may remain active and healthy in the pancreas. This Phase I study for individuals 18-45 years of age and diagnosed with type 1 diabetes in the past 3-48 months will be treated with Proleukin (subcutaneously) 3 times per week for 28 days and Rapamune (orally, daily) for 12 weeks. The trial will test whether the combination of Proleukin and Rapamune can be safely administered and whether treatment halts the autoimmune destruction of remaining beta cells. | ||||||
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| DOI: | 10.21430/M3CRD72E92 | ||||||
| Subjects: | 9 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY567: Shapiro ITN005CT: Islet Transplantation in Type 1 Diabetic Patients | |||||||
| Status: | Updated | ||||||
| Description: | The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression. | ||||||
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| DOI: | 10.21430/M3V0RG6S52 | ||||||
| Subjects: | 34 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY568: Orban ITN012AI: Evaluation of Diabetes Vaccine IBC-VSO1 in Newly Diagnosed Diabetics | |||||||
| Status: | Updated | ||||||
| Description: | This study will evaluate whether IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction, protects against autoimmune attack in newly diagnosed type 1 diabetes patients. Halting beta-cell destruction may result in a prolonged remission and subsequent delay in diabetes related complications. Patients in this study must have been diagnosed with type 1 diabetes no more than 3 months prior to study enrollment. | ||||||
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| DOI: | 10.21430/M3IBWCGI97 | ||||||
| Subjects: | 12 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY569: Herold II ITN007AI: Treatment with hOKT3-gamma-1 (Ala-Ala) in Type 1 Diabetes Mellitus | |||||||
| Status: | Updated | ||||||
| Description: | This open-label phase II trial involving 2 arms where treatment is 0 or 3 cycles of hOKT3gamma1 (Ala-Ala) 6 months apart over the first year of disease in participants with new onset T1DM. Cycles consist of 12 daily doses hOKT3gamma1 (Ala-Ala). | ||||||
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| DOI: | 10.21430/M3WGK6K01J | ||||||
| Subjects: | 11 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY720: Age-related alterations in innate immune responses (See companion study SDY739) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Aging leads to dysregulation of multiple components of the immune system that result in increased susceptibility to infections and poor response to vaccines in the aging population. The dysfunctions of adaptive B and T cells are well documented but the effect of aging on innate immunity remains incompletely understood. Using a heterogeneous population of peripheral blood mononuclear cells (PBMCs), we first undertook transcriptional profiling and found that PBMCs isolated from old individuals (>= 65 yrs) exhibited a delayed and altered response to stimulation with TLR4, TLR7/8, and RIG-I agonists compared to cells obtained from adults (<= 40 yrs). This delayed response to innate immune agonists resulted in the reduced production of pro-inflammatory and antiviral cytokines and chemokines including TNFa, IL-6, IL-1b, IFNg, IFNa, CCL2 and CCL7. While the major monocyte and dendritic cell subsets did not change numerically with aging, activation of specific cell types was altered. PBMCs from old subjects also had a lower frequency of CD40+ monocytes, impaired up-regulation of PD-L1 on monocytes and T cells and increased expression of PD-L2 and B7-H4 on B cells. The defective immune response to innate agonists adversely affected adaptive immunity as TLR-stimulated PBMCs (minus CD3 T cells) from old subjects elicited significantly lower levels of adult T cell proliferation than those from adult subjects in an allogeneic mixed lymphocyte reaction (MLR). Collectively, these age-associated changes in cytokine, chemokine and interferon production, as well as co-stimulatory protein expression could contribute to the blunted memory B and T cell immune responses to vaccines and infections. | ||||||||||
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| DOI: | 10.21430/M3FZ2BAZSA | ||||||||||
| Subjects: | 61 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY756: Histology post influenza | |||||||
| Status: | Updated | ||||||
| Description: | Histological analysis in lung post infection of B6 or B6 A02 transgenic AAD mice with influenza A/PR8/34 virus | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3EWWO0ERE | ||||||
| Subjects: | 1 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||