Effect of Oral Supplement on Influenza Vaccine Long-term Response

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-70
SponsorTsinghua University

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

30 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Tsinghua University

Lead sponsor

Second Affiliated Hospital of Bengbu Medical College

Collaborator