Valneva has announced positive outcomes from its Phase III VLA1553-321 trial of the single-shot IXCHIQ chikungunya virus (CHIKV) vaccine in adolescents.
The trial demonstrated a ‘sustained’ sero-response rate of 98.3% one-year post-vaccination and supports the previously reported data, potentially leading to label extension in Europe, Canada, and the US.
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The multicentre, placebo-controlled, double-blinded, randomised trial involved 754 adolescents aged 12 to 17 years in Brazil.
A consistently high immune response in subjects who were CHIKV-negative at baseline, with a sero-response rate of 98.3% on day 360, was observed in the study’s one-year data.
These figures closely follow the 99.1% response rate observed at six months and 98.8% at 28 days post-vaccination.
In the trial, the geometric mean antibody titers (GMTs) exceeded the sero-response threshold defined by the US Food and Drug Administration (FDA) as the protection surrogate in baseline seronegative subjects who were given a single vaccine dose.
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By GlobalDataNo safety issues were reported by an Independent Data Safety Monitoring Board (IDSMB) and the vaccine was generally well tolerated among adolescents.
Valneva chief medical officer Juan Carlos Jaramillo said: “These additional adolescent data confirm IXCHIQ’s ability to induce a robust, long-lasting antibody response in both younger people and adults with a single vaccination. We are now looking forward to the first data in children which we expect to report imminently.”
Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), which is backed by the European Union (EU)’s Horizon 2020 programme, the trial is conducted in partnership with Instituto Butantan in Brazil.
Valneva’s collaboration with CEPI has been expanded through a $41.3m grant, which aims to facilitate broader access to the vaccine in low- and middle-income countries (LMICs), including post-marketing studies and potential label extensions for children, adolescents, and pregnant women.
Currently, IXCHIQ claims to be the only licensed vaccine for CHIKV globally and is approved for use in adults aged 18 and over in Europe, Canada, and the US.
Last September last year, the company and Pfizer reported positive data from the Phase II trial of a second booster dose of their Lyme disease vaccine candidate.
