VALN - Valneva finishes enrolling in phase 3 trial of single-shot chikungunya vaccine in adolescents

Valneva ( NASDAQ: VALN ) ( OTCPK:INRLF ) said it completed enrollment and vaccination for a phase 3 trial of its single-shot chikungunya vaccine VLA1553 in adolescents.

First results of the trial, dubbed  VLA1553-321, are expected mid-2023.

The trial was conducted in collaboration between Instituto Butantan in Brazil and included 754 adolescents aged 12 to 17 years who were vaccinated following randomization at a 2:1 ratio to receive either VLA1553 or placebo.

The main goal of the study is to evaluate safety and immunogenicity 28 days after the single vaccination with VLA1553.

The company noted that the trial will also provide the first systematic safety and immunogenicity data in participants previously exposed to chikungunya.

The VLA1553-321 adolescent trial is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and is intended to support the label extension in this age group after a potential initial regulatory approval in adults from the U.S. Food and Drugs Administration (FDA), according to the company.

The French drugmaker said that the adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.

In December 2022, Valneva had completed rolling submission of the biologics license application (BLA) to the U.S. FDA for approval of VLA1553 in persons aged 18 years and above.

Valneva noted that if the BLA is approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S.

Chikungunya virus is spread to people via the bite of an infected mosquito.

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