Emergent BioSolutions announced the updated results of its Phase 2 clinical study evaluating the safety and immunogenicity of its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate across a series of dosing regimens.
The interim analysis showed that after the first dose, up to 98 percent of study participants produced a neutralizing antibody response against the virus within seven days after vaccination. Further, the immune response persisted for at least one year on that single dose.
“Emergent is pleased with the positive momentum and progress of our chikungunya vaccine development program,” Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions, said. “Within the last three months, we have received PRIority MEdicines or PRIME designation from the European Medicines Agency (EMA), provided industry input and expertise at the U.S. Food and Drug Administration (FDA) advisory committee meeting on the development path of chikungunya vaccines, and presented updated interim data indicating that a single dose of our vaccine candidate produced an immune response, which persisted through the study participants’ visits at 12 months. There are currently no vaccines or treatments available for chikungunya virus infection and, as a leading provider of travel health vaccines, Emergent is hoping to fill this significant unmet medical need with our CHIKV VLP vaccine once approved. We look forward to continuing to engage with U.S. and European regulators as we prepare to initiate a pivotal trial in 2020.”
This Phase 2 study involved 415 healthy adults at three U.S. sites. The vaccine candidate was well-tolerated across all study arms, and there have been no significant vaccine-related safety concerns identified in the analyses to date. Virus-like particle vaccines are multi-protein structures that mimic naturally occurring viruses without the viral genome.
There is currently no vaccine to prevent chikungunya, which is spread to people through infected mosquitoes. Symptoms include fever, joint pain, headache, muscle pain, joint swelling, or rash. Outbreaks have occurred in Africa, Asia, Europe, and the Indian and Pacific Oceans.
The chikungunya virus was found for the first time in the Americas in 2013 on islands in the Caribbean.