Effect of Oral Supplement on Influenza Vaccine Long-term Response (NCT07357467) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Oral Supplement on Influenza Vaccine Long-term Response
China30 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range
60 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Started using immunosuppressants or hormonal medications after the original study
. Experienced serious illness or hospitalization within the past month, or planning surgery soon
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.