Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-valneva-initiate-phase-3-study-lyme-diseaseNEW YORK & SAINT-HERBLAIN, France--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.
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VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferisensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022. The terms of the collaboration agreement include a $25 million milestone payment made to Valneva upon Pfizer’s initiation of the Phase 3 study. The program was granted Fast Track designation by the U.S. FDA in July 2017.
Phase 3 testing just starting puts possibility of approval a couple of years out. The way it works is interesting. It's a protein subunit vaccine that develops immune reaction against a protein on the target bacterium. The reaction that attacks the bacterium, however, happens inside the tick and prevents the bacteria from leaving the tick and entering the human.
