VALN - Valneva reports positive Phase 3 results for chikungunya vaccine candidate

Valneva (NASDAQ:VALN) announces positive topline results from the Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The trial, involving 4,115 adults, met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects tested for immunogenicity, 95%CI: 96.2-99.6). The seroprotection rate result of 98.5% exceeded the 70% threshold (for non-acceptance) agreed with the FDA. The vaccine candidate was highly immunogenic with a GMT of ~3,270, confirming the immunogenicity profile seen in the Phase 1 trial. VLA1553 was generally well tolerated across all age groups. An independent Data Safety Monitoring Board continuously monitored the study and identified no safety concerns. Final trial results expected within the next six months. The program was awarded Breakthrough Therapy Designation by the FDA in July 2021.

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Valneva reports positive Phase 3 results for chikungunya vaccine candidate