NCT03996538

Vaccination Efficacy With Metformin in Older Adults

Vaccination Efficacy With Metformin in Older Adults: A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

With aging the immune system gets weaker. This makes older adults more susceptible to influenza (flu). Vaccinations help to prevent infection from the flu virus, however the immune system of older adults do not respond as well to vaccines compared to young adults and thus, aren't as well protected from the complications from the flu. This research is being done to determine if Metformin, an FDA-approved diabetes medication, is effective at enhancing immune responses to flu vaccine in older men and women. 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. Immune responses will be evaluated throughout the study at 6 time points.

Conditions

• Aging
• Age-Related Immunodeficiency
• Vaccine Response Impaired

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride Extended-Release Tablets	Subjects will ingest 1500mg/day of metformin hydrochloride extended release. Immune responses will be examined prior to treatment, prior to flu vaccination, and after flu vaccination.
BIOLOGICAL	Influenza Vaccine	All subjects will be vaccinated with high-dose influenza vaccine at the appropriate time of the year per current CDC and FDA recommendations

Timeline

• Start date: 2019-06-05
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2019-06-24
• Last updated: 2020-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study