Phase 1 Study of Safety and Immune Response to SCB-1019T Revaccination in Adults Aged 60 to 85 Previously Vaccinated With AREXVY

What this Trial Is About

Researchers are evaluating the safety, tolerability, and immune response of the SCB-1019T vaccine when given as a revaccination to healthy adults aged 60 to 85 years who were previously vaccinated with AREXVY. This Phase 1 study compares SCB-1019T revaccination to AREXVY revaccination and placebo, aiming to understand how these vaccines perform in older adults. The study is overseen by a safety monitoring committee to ensure participant safety. Participants are randomly assigned to one of four groups a low dose of SCB-1019T, a high dose of SCB-1019T, AREXVY vaccine, or placebo. All vaccinations are given on Day 1. The SCB-1019T vaccine is a novel bivalent recombinant RSV vaccine targeting two main virus strains, while AREXVY is used as an active comparator. The study design allows for evaluation of different vaccine doses and comparison with the original AREXVY vaccine and placebo. During the study, participants will be monitored closely for safety and side effects, especially within 7 and 28 days after vaccination, and throughout a 6-month follow-up period. Assessments include physical exams, laboratory tests, and other procedures to measure immune response and vaccine tolerability. The total participation duration is approximately 6 months, during which data on vaccine safety and immune effects will be collected and analyzed.

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults