About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Tsinghua University
Lead sponsor
Second Affiliated Hospital of Bengbu Medical College
Collaborator