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NCT03996538 · ClinicalTrials.gov registry record · Phase 1
Vaccination Efficacy With Metformin in Older Adults
A Phase 1 study, sponsored by UConn Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03996538: Completed Phase 1 study, sponsored by UConn Health.
NCT03996538 is a Phase 1 study that has completed, run by UConn Health. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996538, a Phase 1 study, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
Change in inducible Granzyme B levels in peripheral blood mononuclear cells (PBMCs) stimulated ex vivo with live flu virus will be compared between the metformin and placebo group.
Interventions
- BIOLOGICAL Influenza Vaccine
- DRUG Metformin Hydrochloride Extended-Release Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2020-02-04 |
| Phase | Phase 1 |
What the finished NCT03996538 record still lists
NCT03996538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Influenza Vaccine is the first listed.
NCT03996538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03996538 about?
NCT03996538 is a clinical study titled "Vaccination Efficacy With Metformin in Older Adults". 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 f...
What is the current status of trial NCT03996538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-06-05. Estimated completion is 2020-02-04.
What interventions are being tested in trial NCT03996538?
The interventions under investigation include: Influenza Vaccine (BIOLOGICAL), Metformin Hydrochloride Extended-Release Tablets (DRUG).
Who is sponsoring clinical trial NCT03996538?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03996538's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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