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Clinical Trials: Aging
IRB No. 12-188-2 (Dr. George Kuchel, PI): Impact of Aging T Cell Responses to Influenza Vaccination
Participate in our research study on the immune system looking at how we can use vaccines to protect us against infections. With aging, that system does not function as well. We think this research will provide information that could eventually lead to more effective vaccines for preventing influenza illness and potentially other infectious diseases in older people. Men and Women must be 20-30 years old OR 50 years of age and Older; Have been vaccinated in last year, but not for current flu season; Do not have any Immunosuppressive diseases or on any Immunosuppressive therapy. Participants must be willing to come in for 4 study visits where blood will be drawn at 3 visits. Standard Flu vaccinations will be given as part of the study at no charge. Monetary compensation will be provided.
IRB No. 14-194J-3.2 (Dr. George Kuchel, PI): Impact of aging on gene expression and RNA splice variants in peripheral blood cells
PRIMARY HYPOTHESIS We will be able to gain a comprehensive view of the genomic alterations associated with aging and frailty using immunological and system biology approaches. Furthermore, we theorize that these changes will be associated with specific microbiome composition. SPECIFIC AIMS This is a single-center exploratory study to carry out transcriptional and microbiome profiling analysis to gain a comprehensive view of genomic alterations associated with aging and frailty. Aim 1: To collect the samples from well-characterized volunteer cohorts. Aim 2: To establish whole blood isoform profiles. Aim 3: To establish epigenetic profiles of PBMCs and sorted blood cells Aim 4: To characterize microbiome in saliva and stool samples. Aim 5: To devise informatics methods to uncover the dynamics of transcriptional regulatory program associated with pathologies in human cells, in particular with the aging of immune cells. Aim 6: To evaluate epigenetic data using developed algorithms to address the following questions: 6a: Which regulatory programs and regulatory interactions are disrupted with aging and in which immune cells? 6b. How do men and women age differently based on transcriptional data (sex effects)? 6c. What are the putative genomic/clinical/immunological markers of healthy aging? SIGNIFICANCE It becomes critically important to apply system biology approaches and in-depth genomics to understand aging and related alterations. Identifying the immunologic parameters that correlate with or predict immune alterations will have a significant impact on the increased understanding of disease physiology in older age and eventually novel biomarkers and targets for therapy. RELEVANCE Recent technological breakthroughs have made the study of biological systems on a large scale a reality, thus offering unprecedented opportunities to comprehensively profile genome and immune responses in human subjects. A major challenge when engaging in such studies is to establish baseline values in subjects over time under "healthy" conditions. This data will be used as a basis for design of futures studies identifying changes occurring in response to challenge as for example acute infection or vaccination.
IRB No. 19-205-2: Vaccination Efficacy with Metformin in Older Adults: A Pilot Study (VEME)
VEME is a double-blinded placebo-controlled trial in men and women over the age of 65 years. It will determine whether metformin can increase influenza (flu) vaccine efficacy in older adults, specifically focusing on cell-mediated responses. Participants will be randomly assigned to either metformin or placebo treatment for a total of 22 weeks. Participants will be vaccinated with high-dose flu vaccine after 12 weeks of treatment. Blood will be drawn prior to treatment, prior to vaccination (week -12 and week -5), and 1, 5, and 10 weeks post vaccination. Peripheral blood mononuclear cells (PBMCs) will be analyzed for cell-mediated responses and serum will be used for flu antibody titers. The overall hypothesis is that metformin will enhance flu vaccine efficacy via targeting age-related changes in intracellular metabolism of immune cells. Primary Outcome: The primary outcome is cell-mediated immune responses to flu vaccine, specifically inducible Granzyme B (GrB) and interferon-? (IFN-?)/interleukin-10(IL-10) ratio in PBMCs stimulated with live flu virus. Secondary Outcomes: Secondary outcomes include flu antibody titers, frailty phenotype, and T cell metabolic cellular profiles. Population: Forty older adults (65 years and older), with approximately 50% men and 50% women. VEME will exclude persons with prediabetes, diabetes, and contraindications to receiving metformin or the flu vaccine. Study Agent: Metformin Hydrochloride Extended-Release, 1500mg/day (three 500mg ER tablets once a day, starting at 500mg ER/day and progressed per current recommendations) and high dose quadrivalent inactivated influenza vaccine (Sanofi Pasteur Inc) Participant Duration: 22 weeks of treatment (up to 27 weeks of participation from screening visit) Study Duration: Recruitment and screening will take place approximately May to July. First dosing of first patient will begin approximately July 15th at the earliest and the first dosing of the last patient will be approximately September 4th at the latest (flu vaccination after 12 weeks of treatment, between October and November). The last patient last visit will be approximately February 10th at the latest (10 weeks post flu vaccine with + 1 week flexibility range).