Valneva success with single-shot chikungunya vaccine candidate

French vaccines developer Valneva (Euronext Paris: VLA) has announced positive top-line results from the lot-to-lot Phase III trial of its single-shot chikungunya vaccine candidate, VLA1553.

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.

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 excellent immunogenicity profile demonstrated in the pivotal Phase III trial, VLA1553-301. All three lots were equally well tolerated and the safety profile was consistent with results in the pivotal Phase III trial. Study VLA1553-302 therefore confirmed clinical equivalence as well as manufacturing consistency of the three lots.