A mosquito-borne viral infection spreading in the Americas and Europe, caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. As of September 2020, there have been more than 3 million reported cases in the Americas1 and the economic impact is significant (e.g. Colombia outbreak 2014: $73.6m2).
VLA1553 – Valneva’s chikungunya vaccine candidate
- To Valneva’s knowledge, VLA1553 is currently the only chikungunya vaccine candidate in Phase 3 clinical trials that targets long-term protection following the administration of a single dose.
- Valneva reported positive topline results from a Phase 3 pivotal trial in August 20213. The trial, involving 4,115 adults, aged 18 years and above, across 44 sites in the U.S., met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot. VLA1553 was also generally well tolerated among the 3,082 subjects evaluated for safety.
- The trial will continue towards final analysis including the 6-month safety data. Final trial results are expected within the next six months.
- The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).
- VLA1553 has received Fast Track and Breakthrough Therapy4 designation from the FDA and PRIME designation from the EMA5,6.
Additional information about chikungunya:
- PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas
- Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015
- Valneva press release: https://valneva.com/press-release/valneva-announces-positive-phase-3-pivotal-results-for-its-single-shot-chikungunya-vaccine-candidate/
- Valneva press release: http://valneva.com/press-release/valneva-awarded-fda-fast-track-designation-for-chikungunya-vaccine-candidate/
- Valneva press release: https://valneva.com/press-release/valneva-awarded-fda-breakthrough-designation-for-its-single-shot-chikungunya-vaccine-candidate
- Valneva press release: https://valneva.com/press-release/valnevas-chikungunya-vaccine-candidate-awarded-ema-prime-designation/