Phase 3b Study to Test the Safety and Effectiveness of an Adjuvanted Chikungunya Virus-like Particle Vaccine for Preventing Chikungunya Disease in Adolescents and Adults

What this Trial Is About

Researchers are evaluating the efficacy, immune response, and safety of the CHIKV VLP vaccine to prevent Chikungunya disease in adolescents and adults aged 12 years and older. This phase 3b study uses advanced infectious disease models and analytics to select regions and clinical sites, set study timelines, and optimize study parameters against local Chikungunya virus conditions to address challenges in assessing vaccine efficacy. Participants will be randomly assigned to receive either the CHIKV VLP vaccine with an adjuvant or a placebo. The vaccine consists of a 0.8 mL intramuscular injection containing 40 g of CHIKV VLP adsorbed on aluminum hydroxide. The study includes two groups one receiving the active vaccine and one receiving placebo. It follows participants from 14 days after vaccination up to 1095 days to assess disease prevention and immune response. During the study, participants will be monitored for confirmed acute, chronic, and severe Chikungunya disease cases. Safety is tracked by recording local and unsolicited adverse events up to 28 days postvaccination and serious or medically attended events throughout the study. Blood samples will measure antibody responses at three weeks postvaccination. The total study duration is up to three years, allowing detailed follow-up on vaccine effects and safety.

An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults