- Highly differentiated vaccine candidate with potentially compelling immunogenicity owing to its VLP structure
- Phase 3 program met its primary endpoint, demonstrating high seroresponse rate and fast onset of response
- Regulatory submissions planned for 2024
CHIKV VLP is a virus-like particle (VLP)-based vaccine candidate in Phase 3 clinical development for active immunization against chikungunya disease.
The Phase 3 development program for CHIKV VLP consists of two studies. One is a multi-center, randomized, double blind, placebo-controlled study evaluating the safety and immunogenicity of the CHIKV VLP vaccine candidate in healthy individuals aged 12 to 64 and aims to compare clinically relevant difference in immune response rate between the candidate vaccine and placebo. It also aims to demonstrate the consistency of the chikungunya virus serum neutralizing antibody response across three manufactured vaccine candidate lots. Results from this study were reported in August 2023.
The second study evaluated the safety and immunogenicity of the CHIKV VLP vaccine in 413 adults ≥65 years of age. Initial results from this study were reported in June 2023.
CHIKV VLP has received Breakthrough Therapy designation and Fast Track designation from the FDA, and PRIME designation from EMA.
Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, joint pain, headache, muscle pain, joint swelling or rash, with some symptoms lasting months or even years. The geographic distribution of chikungunya has expanded to more than 100 countries and territories worldwide. There is currently no licensed vaccine to prevent chikungunya virus disease.