Chikungunya – VLA1553

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 the only chikungunya vaccine candidate in Phase 3 clinical trials.
  • VLA1553 is a single dose, live-attenuated vaccine candidate against chikungunya.
  • In Phase 1 clinical trials, Valneva observed that VLA1553 led to the development of antibodies to chikungunya in 100% of the 120 healthy participants in this trial.3
  • Based on this Phase 1 dataset, Valneva has advanced VLA1553 directly into Phase 3 clinical trials4 and is currently conducting a pivotal trial in 4,131 healthy adults. Recruitment for the Phase 3 clinical trial was completed in April 20215.
  • Valneva anticipates reporting the initial results from its Phase 3 clinical trial in mid-2021 and believes that the outcome, if positive, may provide the basis for regulatory approval.
  • VLA1553 has received Fast Track designation from the FDA and PRIME designation from the EMA6,7.

 

Additional information about chikungunya:

  1. PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas
  2. Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015
  3. Valneva press release: https://valneva.com/press-release/valneva-reports-excellent-final-phase-1-results-for-its-chikungunya-vaccine-candidate-confirms-plans/
  4. Valneva press release: https://valneva.com/press-release/valneva-initiates-phase-3-clinical-study-for-its-chikungunya-vaccine-candidate-vla1553/
  5. Valneva press release: http://valneva.com/press-release/valneva-awarded-fda-fast-track-designation-for-chikungunya-vaccine-candidate/
  6. Valneva press release: https://valneva.com/press-release/valneva-completes-recruitment-for-pivotal-phase-3-trial-of-chikungunya-vaccine-candidate-and-initiates-antibody-persistence-trial/
  7. Valneva press release: https://valneva.com/press-release/valnevas-chikungunya-vaccine-candidate-awarded-ema-prime-designation/