Valneva SE announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The final analysis included six-month follow-up data and confirmed the topline results reported in December 2021.
The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.
The trial included 408 participants aged 18 to 45 years. The safety profile shown in study VLA1553-302 was similar to the Phase 3 trial, VLA1553-3011. With a 96.0% seroprotection rate at Day 180, the immunogenicity profile from study VLA1553-301 was also confirmed.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “We are extremely pleased that the final lot-to lot data confirmed the previously reported topline results. We have now all necessary clinical data to support submission with the US Food and Drug Administration (FDA), which we plan to start later this year. Chikungunya is a major, growing and unmet public health threat, yet no vaccine or specific treatment is currently available to prevent this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
Valneva’s chikungunya program was awarded Breakthrough Therapy Designation by the US FDA in July 2021. This milestone followed the US FDA’s Fast Track designation and the European Medicines Agency (EMA)’s PRIME designation which the Company received in December 2018 and in October 2020, respectively. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).
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