Chikungunya Vaccine for Children Study Completes Enrollment Milestone

Valneva SE today announced that it completed enrollment and vaccination for a Phase 3 clinical trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553.

This live-attenuated, investigational vaccine candidate targets the chikungunya virus and was designed by deleting a part of the chikungunya virus genome.

The initial results of this trial are expected in mid-2023, which are intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S.).

This adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the FDA in the U.S.

Furthermore, the adolescent trial is expected to supvaccine'svaccine's licensure in Europe and Brazil, which would be the first potential approval for use in these chikungunya endemic regions.

Previously, Valneva completed the rolling submission of the Biologics License Application (BLA) to the FDA for approval of VLA1553 in persons aged 18 years and above (adults) in December 2022. 

If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S.

The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination.

Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this pediatric study, commented in a press release on February 14, 2023, "Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur."

"The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licensed for use."

"Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.

To make VLA1553 more accessible to Low- and Middle-Income Countries, Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing, and marketing of the chikungunya vaccine.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes.

A CHIKV infection leads to symptomatic disease in up to 97% of humans after three to seven days following the mosquito bite.

While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia.

Additional chikungunya outbreak news at Vax-Before-Travel.