Effect of Oral Supplement on Influenza Vaccine Long-term Response
Starting soon
Conditions studied: Influenza, Immunosenescence
In brief
This is a follow-up study of a previously completed randomized controlled trial (NCT06827873) that investigated the effects of oral supplements on influenza vaccine response in adults aged 60-70 years. The original study was completed in April 2025, with participants receiving either TUDCA (Tauro Ursodesoxy Cholic Acid) supplementation, fatty acid supplementation, or placebo during influenza vaccination. The primary objectives of this follow-up study are to: 1. Evaluate the durability of vaccine-induced antibody responses approximately 8 months post-vaccination 2. Assess the persistence of immune memory cells, particularly long-lived plasma cells and memory B cells 3. Compare long-term immune responses between the TUDCA supplementation group and placebo group This observational follow-up involves a single visit where participants will: 1. Provide one blood sample for antibody and immune cell analysis 2. No intervention or vaccination will be administered The study will specifically focus on B cell subsets through flow cytometry analysis, including total B cells, memory B cells, plasma cells, and long-lived plasma cells. This research aims to determine whether TUDCA supplementation can enhance the durability of vaccine-induced immunity in older adults.
Key facts
- Study ID
- NCT07357467
- Run by
- Tsinghua University
- People needed
- 30
- Starts
- 2026-03-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 60 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Originally assigned to either the TUDCA supplementation group or placebo control group
- No influenza vaccination or other vaccines received between April 2025 and December 2025
- Willing to participate in this follow-up study and sign supplementary informed consent
- Stable health condition
You may not qualify if…
- Started using immunosuppressants or hormonal medications after the original study
- Experienced serious illness or hospitalization within the past month, or planning surgery soon
- Experienced fever, cold, severe diarrhea, or taken influenza antiviral medications within the past month
- Unable or unwilling to participate in blood collection
- Lost to follow-up or unable to contact
Where it is running
- Tsinghua University — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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