About this trial
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
Qualifiers
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.
Disqualifiers
Previous vaccination against yellow fever, dengue either with a registered product or from participation in a previous vaccine study.
Previously received AS01-adjuvanted vaccines (e.g. Recombinant zoster vaccine, RTS,S/AS01, RSVPre-F3-AS01), either with a registered product or from participation in a previous vaccine study.
Planned administration of a AS01-adjuvanted vaccine or yellow fever vaccine other than the study vaccine during the study.
Subjects who have been unwell in the last 7 days prior to screening.
Trial design
Treatments tested in this trial
- AS01 adjuvant (0.5 mL intramuscular)
- YF17D (Stamaril, Sanofi-Pasteur)
- Placebo (NaCl 09%, 0.5mL)
Treatment groups
Sponsors and collaborators
Singapore General Hospital
Lead sponsor
A*STAR Infectious Diseases Labs
Collaborator