Emergent BioSolutions begins phase 3 trial of CHIKV VLP vaccine candidate
Emergent BioSolutions said that it has dosed the first participant in a phase 3 clinical trial of CHIKV VLP — the company’s single-dose chikungunya vaccine candidate.
The American biopharma company will test the safety and immunogenicity of the investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine.
According to Emergent BioSolutions, CHIKV VLP is the only VLP-based vaccine that is presently in clinical development to provide active protection against chikungunya disease.
The purpose of the multi-center, randomized, double blind, placebo-controlled late-stage study is to assess the safety and immunogenicity of CHIKV VLP in healthy people, aged from 12 to 64. It will enroll at least 3,150 people from as many as 49 US sites.
Besides, the phase 3 clinical trial will aim to establish the consistency of the chikungunya virus (CHIKV) serum neutralizing antibody (SNA) response in three vaccine candidate batches.
The phase 3 chikungunya vaccine study will examine the response invoked by CHIKV SNA at day 22, as determined by the seroresponse and geometric mean titer rate.
Karen L. Smith — Emergent BioSolutions executive vice president and chief medical officer said: “Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine candidate.
“I am proud of the Emergent team for bringing us a step closer to potentially having a critical solution to address this important disease for which no vaccine or treatment is currently available. A true demonstration of our commitment to our mission – to protect and enhance life.”
Emergent BioSolutions said that the structure of CHIKV VLP is almost identical to that of the wild-type virus, but it does not present a threat of replication.
The CHIKV VLP vaccine candidate has both breakthrough therapy designation and fast track designation from the US Food and Drug Administration as well as the PRIME designation from the European Medicines Agency.