Valneva SE, a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced the initiation of a pivotal Phase 3 clinical trial for its differentiated, single-shot chikungunya vaccine candidate VLA1553. 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).

Chikungunya virus/CDC

The study, called VLA1553-301, is a double-blinded, placebo-controlled, multi-center study in approximately 4,000 healthy adults aged 18 or above, conducted in the U.S. Participants will be randomized into two study groups to receive either vaccine or placebo. The primary endpoint will be to demonstrate safety and immunogenicity 28 days after a single-shot vaccination with VLA1553. A subset of participants will be tested for sero-protection based on an immunological surrogate (under the Accelerated Approval pathway). Participants will be followed for a total of six months.

The total duration of the study is expected to be nine months and the outcome, if positive, shall provide the basis for licensure of the vaccine.

Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva, commented, “We are the first company worldwide to advance a chikungunya vaccine candidate into Phase 3. We believe that VLA1553 has best-in class potential. Developing a vaccine against chikungunya is critical as the virus represents a major public health threat and there are currently no preventive vaccines or effective treatments available. We would like to thank our employees who are making this trial possible despite the ongoing COVID-19 pandemic.”

Valneva plans to take VLA1553 to market with the prospect of leveraging major manufacturing and commercial synergies with its existing travel vaccines portfolio.

The target population segments are travelers, military personnel and individuals at risk living in endemic regions. The global market for vaccines against chikungunya is estimated to exceed $500 million annually, including a traveler vaccine market potential of ~$250 million.

Aedes aegypti mosquito

To make VLA1553 also accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed a binding term sheet in May 2020 for the development, manufacturing and marketing of VLA1553. The collaboration will be effective upon the signing of definitive agreements and will fall within the framework of the $23.4 million funding which Valneva received from the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2019.