NCT07527247 Improving Vaccine Protection for Older Adults
| NCT ID | NCT07527247 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Singapore General Hospital |
| Condition | Immune System Responses and Trained Immunity After AS01 Administration |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2029-02-28 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
As people grow older, their immune system - the body's natural defence against diseases - becomes weaker, making them more vulnerable to infections and less responsive to vaccines. This was clearly seen during the COVID-19 pandemic, where older adults were more likely to develop severe illness. Researchers have made an interesting discovery about AS01, an ingredient already used in successful vaccines like the shingles vaccine. They found clues that AS01 might work like a general fitness trainer for the immune system, potentially making it stronger and better at fighting off various types of infections, not just specific ones. To confirm this possibility, we are conducting this research study with adults aged 21-59 to test whether AS01 by itself can boost and train the immune system, how long this boost lasts, and if it actually helps you fight off other infections more effectively.
Eligibility Criteria
Inclusion Criteria: * Adults aged 21 to 59 years of age at time of screening. * BMI 18.5 - 27.5 kg / m2 (BMI values for Asian population according to MOH guideline NIH Consensus Conference). * Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. For subjects with underlying comorbidities, the conditions must be deemed stable by the investigators, and they must not have any hospitalisation relating to these conditions in the last 6 months. * Voluntarily participate, understand and sign an informed consent form approved by the Ethical Review Board. * Subjects who are willing to comply with the requirements of the study protocol and scheduled visits. These requirements include completion of the subject diary, return for follow-up visits. Subjects should also be willing to make themselves available for the duration of the study, with access to a consistent means of contact. * Accessible vein at the forearm for blood taking. * Female subje