Valneva initiated a Phase 1 clinical trial in the US to evaluate the safety and immunogenicity of VLA1553, its live-attenuated vaccine candidate against chikungunya.
Update: May 2, 2019: Valneva reported positive Phase 1 interim results for, VLA1553, its chikungunya vaccine candidate.
The interim results showed an excellent immunogenicity profile after a single vaccination with a 100% seroconversion rate achieved at Day 28 in a pooled analysis of all vaccinated groups.
Results also showed that 96.5% of subjects achieved at least a 16-fold increase in antibody titres and a high geometric mean titre, fully supporting VLA1553′s differentiated target product profile.
The pooled safety profile of all groups was considered acceptable, supporting further development.
No serious adverse events nor adverse events of special interest were reported up to Day 28 and the local tolerability was considered excellent.
Valneva expects unblinded safety and immunogenicity data at dose group level by mid-2019, which will include additional information on whether subjects are protected from chikungunya viremia.
Clinical Trial NCT03382964: A Phase 1 Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers