Emergent’s CHIKV-VLP vaccine candidate is currently being investigated in a Phase 2 parallel-group, randomized, double-blind, dose-finding study. The CHIKV-VLP vaccine is a multi-protein structure that mimics 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 the chikungunya virus.
During November 2019, the company presented updated results indicating that after a single dose, up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus within seven days after vaccination. Further, the immune response persisted for at least one year for subjects who received a single dose. The vaccine candidate was well-tolerated across all study arms and no significant vaccine-related safety concerns have been identified in analyses to date. Solicited adverse event profiles were similar across groups and mostly mild or moderate.
The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received FDA Fast Track designation in May 2018 and EMA PRIME designation in September 2019.
The CHIKV-VLP vaccine candidate is indicated to prevent the 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.
January 13, 2020 - Emergent BioSolutions Inc. announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.
November 22, 2019 - Emergent BioSolutions announced updated results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate across a series of dosing regimens.
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.
CHIKV-VLP Clinical Trials:
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
Chikungunya vaccine news is published by Precision Vaccinations.com.