Effect of Oral Supplements for Influenza Vaccine Response
Launched by TSINGHUA UNIVERSITY · Feb 10, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring whether certain oral supplements made from fatty acids and bile acids can help improve the immune response to the flu vaccine in adults aged 60 to 70 years. The researchers want to see if these supplements can make the vaccine work better and if they are safe for older adults. They will also look at how gut bacteria might influence the immune response. Participants in the study will take either the supplements or a placebo (a non-active pill) daily for 25 days, get the flu vaccine on day 4, and provide blood and stool samples at different times to help evaluate their immune response.
To be eligible for this trial, participants must be between 60 and 70 years old, have a body mass index (BMI) within a healthy range, and should not have received a flu vaccine in the past year. They should also be able to understand and agree to participate fully. Those with certain health conditions, recent medications, or other vaccines may not qualify. If you join the trial, you’ll be contributing to important research that could help improve vaccine effectiveness for older adults in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age 60-70 years old
- • 2. Body Mass Index (BMI) 18.5-26.9 kg/m²
- • 3. No influenza vaccination in the past year
- • 4. Able to understand and sign the informed consent form, and capable of completing the full follow-up process
- Exclusion Criteria:
- • 1. Severe lipid metabolism disorders
- • 2. Use of lipid-lowering medications, weight loss drugs, or insulin within the past three months
- • 3. Vaccination with other vaccines within the past three months
- • 4. Use of probiotics or prebiotics within the past three months
- • 5. Use of steroids, immunosuppressants, or other hormonal medications within the past year
- • 6. Immunodeficiency diseases
- • 7. Severe vaccine allergy history
- • 8. Liver or kidney metabolic disorders
- • 9. Occurrence of fever, common cold, severe diarrhea, or other diseases within the past month
- • 10. Poorly controlled chronic diseases (such as blood pressure, blood sugar)
- • 11. Intake of influenza antiviral drugs within the past two weeks
- • 12. Cognitive function impairment
- • 13. Planning to undergo surgery in the near future
About Tsinghua University
Tsinghua University, a prestigious research institution located in Beijing, China, is dedicated to advancing scientific knowledge and innovation in various fields, including medicine and healthcare. As a clinical trial sponsor, Tsinghua University leverages its extensive academic resources and interdisciplinary expertise to conduct rigorous research aimed at improving patient outcomes and advancing medical science. The university fosters collaboration among researchers, healthcare professionals, and industry partners to ensure the successful design and execution of clinical trials, ultimately contributing to the development of novel therapies and healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported