Valneva SE (NASDAQ:VALN) 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.
- Related: Valneva's Chikungunya Vaccine Candidate Shows Protective Neutralizing Antibodies In Late-Stage Trial.
- 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: VALN shares are closed at $57.39 on Tuesday.
