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Vaccination Efficacy with Metformin in Older Adults: A Pilot Study (VEME)
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19-205-2
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Vaccination Efficacy with Metformin in Older Adults: A Pilot Study (VEME)
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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).
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Aging
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Healthy Volunteer
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Check with study contact
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Nancy Dean. Telephone: (860) 679-8865. Email: Ndean@uchc.edu or Lisa Pesce. Telephone: (860) 679-2305. Email: Kenyon-Pesce@uchc.edu
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Enrolling/recruiting. For current recruitment status, please check with study contact.
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