Single-Shot Chikungunya Vaccine Candidate Launches Phase 3 Study for Adolescents

France-based Valneva SE announced the initiation of a Phase 3 trial in adolescents located in Brazil for its live-attenuated, single-shot chikungunya vaccine candidate, VLA1553. It has been designed by deleting a part of the chikungunya virus genome.

Valneva expects to report final results from VLA1553-301 in the first quarter of 2022.

VLA1553 is a vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries, reports the WHO.

Funded by the Coalition for Epidemic Preparedness Innovations, the trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the U.S. FDA.

It is also expected to support the licensure of the VLA1553 vaccine in Brazil.

Prof. Dimas Tadeu Covas, President of Instituto Butantan, which sponsors the VLA1553-321 trial, commented in a press release issued on January 31, 2022, "VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide, having successfully completed Phase 3 in adults."

"Through developing, producing and commercializing Valneva's chikungunya vaccine, Butantan reinforces, even more, its engagement to improve public health in developing countries."

Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary.

At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period last year.

The southeast of the country, where São Paulo and Rio de Janeiro are located, presented a higher incidence with 29,700 cases of chikungunya, including 14,300 cases in São Paulo compared to 281 last year.

At the beginning of August 2021, Valneva announced positive topline results for the pivotal Phase 3 trial VLA1553-301 in adults aged 18 years and above.

After a single vaccination, the vaccine candidate induced protective chikungunya-virus neutralizing antibody titers in 98.5% of trial participants and was well tolerated across all age groups.

The Company also reported positive primary endpoint data from its ongoing lot-to-lot manufacturing consistency trial VLA1553-302 in December 2021.

Valneva is a specialty vaccine company located in Saint-Herblain, France, focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need.