VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate for protection against chikungunya.
It was granted Fast Track designation by the US Food and Drug Administration (FDA) in December 2018.
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 22, 2019: Phase 1 unblinded results up to month 7 showed excellent immunogenicity and safety profile confirming Valneva's unique, single-shot vaccine candidate.
These results strongly support further development acceleration
- VLA1553 was generally safe in all dose groups
- Well-tolerated in the low and medium dose. (Superior safety profile, including viremia, compared to the high dose group)
- Excellent local tolerability
- Excellent immunogenicity profile in all dose groups after a single vaccination
- 100% Seroconversion1 achieved at Day 14 after a single vaccination in all dose groups
- Sustained at 100% after six months
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.
Clinical Trial NCT03382964: A Phase 1 Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers