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Valneva Reports Further Positive Phase 2 Safety and Immunogenicity Results for Lyme Disease Vaccine Candidate
Globenewswireยท 2025-09-03 05:00
Core Insights - Valneva SE announced positive immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, showing strong immune response and favorable safety profile after a third booster dose [1][3][4] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [12] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [13] Vaccine Development - VLA15 is the only Lyme disease vaccine candidate in advanced clinical development, with two Phase 3 trials nearing completion [2][6] - The vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease, and aims to inhibit the bacterium's ability to infect humans [6][8] Clinical Study Results - The Phase 2 study (VLA15-221) involved 560 healthy participants aged 5 to 65, demonstrating a 100% seroconversion rate across all age groups after the third booster dose [3][9] - The safety profile after the third booster was consistent with previous doses, with no safety concerns reported by the independent Data Monitoring Committee [4][7] Market Need - There are currently no approved human vaccines for Lyme disease, with approximately 476,000 cases diagnosed annually in the U.S. and 132,000 in Europe, highlighting a significant unmet medical need [2][11] - The geographic expansion of Lyme disease increases the urgency for vaccination solutions [3][11] Collaboration - Valneva has a collaboration agreement with Pfizer for the development and commercialization of VLA15, initiated in April 2020 [4]