Chikungunya Virus virus-like particle (CHIKV-VLP) vaccines are multi-protein structures that mimic the organization and conformation of naturally occurring viruses, without the viral genome, that could potentially promote a stronger immune response and increased antibody production.
Studies have shown that VLP vaccines are highly immunogenic, have a proven safety record, and typically elicit high titer neutralizing antibodies needed to protect against chikungunya virus.
The CHIKV-VLP vaccine candidate is indicated to prevent chikungunya virus.
The CHIKV-VLP vaccine candidate is administered in the clinical trial as an intramuscular injection.
It received Fast Track designation from the U.S. Food and Drug Administration in May 2018.
April 16, 2019: Emergent BioSolutions announced results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity:
- A single dose administered, seroconversion occurred in 74 to 98 percent of subjects within 7 days.
- And, in all subjects by 28 days after the last dose.
- Further, the immune response was shown to be persistent through the 6-month visit, including in the 1-dose regimen.
- Phase 3 trial first subject enrollment targeted for 2020.
Clinical Trial NCT03483961: Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
- The Phase 2 parallel-group, randomized, double-blind, dose-finding study involved 415 healthy adults in 3 U.S. sites. Participants were given a 1- or 2-dose series, with or without an adjuvant, over a 4-week period.
- The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
- Primary Objective:
- To assess the immune response to the vaccine
- Secondary Objectives:
- To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
- Safety Objective:
- To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine