Valneva Posts Positive Lot-to-Lot Consistency Data For Its Single-Dose Chikungunya Vaccine

Benzinga2021-12-22

Valneva SE announced topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.

  • The trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses on Day 29 after vaccination.
  • Lot-to-lot trials demonstrate manufacturing consistency, one of the standard requirements for vaccine licensure.
  • The trial, which included 408 participants aged 18 to 45 years, confirmed the favorable immunogenicity profile demonstrated in the pivotal Phase 3 trial.
  • All three lots were equally well-tolerated, and the safety profile was consistent with the pivotal Phase 3 trial results.
  • The lot-to-lot data will be part of its submission with the FDA expected to start in 2022.
  • The lot-to-lot trial will continue towards the final six-month analysis, with final trial results expected in Q2 of 2022.
  • Chikungunya is a mosquito-borne viral disease.
  • VLA1553 is a live-attenuated, single-dose vaccine candidate targeting the chikungunya virus. It has been designed by deleting a part of the chikungunya virus genome.
  • Price Action: VLAN shares are closed at $57.39 on Tuesday.
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