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 is a monovalent, single dose, live-attenuated vaccine candidate against chikungunya.
- VLA1553 was granted Fast Track designation by the FDA in December 20183.
- Valneva reported excellent final Phase 1 results for VLA1553 in November 20194.
- Valneva successfully completed an End-of-Phase 2 meeting with the FDA and agreed on the clinical development plan towards licensure5.
- Valneva initiated a pivotal Phase 3 trial for VLA1553 in September 20206.
- The total duration of the study is expected to be nine months and the outcome, if positive, shall provide the basis for licensure of the vaccine.
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: http://valneva.com/press-release/valneva-awarded-fda-fast-track-designation-for-chikungunya-vaccine-candidate/
- Valneva press release: https://valneva.com/press-release/valneva-reports-excellent-final-phase-1-results-for-its-chikungunya-vaccine-candidate-confirms-plans/
- Valneva press release: https://valneva.com/press-release/valneva-reports-positive-end-of-phase-2-chikungunya-meeting-with-the-u-s-fda-sets-stage-for-phase-3-study/
- Valneva press release: https://valneva.com/press-release/valneva-initiates-phase-3-clinical-study-for-its-chikungunya-vaccine-candidate-vla1553/