The CHIKV-VLP chikungunya virus vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
It received Fast Track designation from the U.S. Food and Drug Administration in May 2018.
Virus-like particle (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 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.
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.