The Effects of Pre-Existing Antibodies on Live-Attenuated Viral Vaccines.
Darren Z L Mok, Kuan Rong Chan
https://pubmed.ncbi.nlm.nih.gov/32397218Actively Recruiting
Led by Singapore General Hospital · Updated on 2026-05-18
40
Participants Needed
1
Research Sites
N/A
Total Duration
S
Singapore General Hospital
Lead Sponsor
A
A*STAR Infectious Diseases Labs
Collaborating Sponsor
Researchers are studying how the immune system weakens with age, making older adults more prone to infections and less responsive to vaccines. This trial focuses on AS01, an ingredient used in vaccines like the shingles vaccine, which may act like a fitness trainer for the immune system. The study aims to see if AS01 alone can boost and train the immune system in healthy adults aged 21 to 59, how long this effect lasts, and whether it helps fight other infections better. Participants receive a single intramuscular dose of either AS01 or a placebo on the first day. Then, they are randomly assigned to get a live-attenuated yellow fever vaccine (YF17D) either one month or three months later. There are four groups in total: AS01 plus yellow fever vaccine at 1 month, AS01 plus yellow fever vaccine at 3 months, placebo plus yellow fever vaccine at 1 month, and placebo plus yellow fever vaccine at 3 months. This design helps researchers study immune responses over approximately 2 to 4 months. Throughout the study, participants will have blood samples taken at multiple timepoints to measure immune changes, including gene and epigenetic markers, and immune responses to the yellow fever vaccine. Researchers will analyze how well the immune system controls the viral challenge and monitor safety, including common injection site reactions and systemic symptoms. The total participation time depends on the assigned group and lasts up to about 3 months.
CONDITIONS
Improving Vaccine Protection for Adults
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive a single intramuscular dose of AS01 adjuvant or placebo on Day 0. Then participants receive the licensed live-attenuated yellow fever vaccine (YF17D) either at 1 month (Day 30) or 3 months (Day 90) after AS01/placebo, based on randomization.
Visits on Days 0, 7, 14, 28, 30 or 90, and 37 or 97
Duration - Up to 4 months depending on group assignment
Participants undergo serial blood sampling to measure immune response, durability, and response to the viral challenge. Monitoring includes visits up to 3 months after the yellow fever vaccine.
Additional visits on Days 56, 84, and 120 depending on assignment
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
C
Candice Y.Y. Chan, MBChB, MRCP
C
Christina Titin
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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