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Monday, Valneva SE (NASDAQ:VALN) released further Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine.
Following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months (Day 180) after vaccination with a single dose of the vaccine.
The Day 180 results confirm the initial immunogenicity and safety data Valneva reported previously and are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years.
The data are also expected to support the licensure of IXCHIQ in Brazil, which would be the first potential approval for use in endemic populations.
The latest VLA1553-321 data confirmed that a single-dose vaccination with VLA1553 induced a high, sustained immune response with a seroresponse rate of 99.1% (232 out of 234 participants) at Day 180 compared to 98.8% (248 out of 251 participants) at Day 29 in an immunogenicity subset of individuals who were CHIKV negative at baseline.
Geometric mean antibody titers (GMTs) consistently surpassed the seroresponse threshold defined with the FDA as the surrogate of protection in baseline seronegative participants who received a single dose of VLA1553.
Additionally, the Day 180 data confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents receiving VLA1553, irrespective of previous infection with the chikungunya virus.
Most solicited adverse events observed following VLA1553 administration were mild or moderate and resolved within three days post-vaccination.
Valneva’s vaccine IXCHIQ is the world’s first and only licensed chikungunya vaccine available.
The FDA approved the vaccine in November 2023, and the Centers for Disease Control and Prevention recently adopted the Advisory Committee on Immunization Practices’ recommendations on vaccine use in the U.S.
Price Action: VALN shares are up 0.41% at $7.45 at last check Monday.
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Posted In: VALN
