Phase 3 VALOR Trial

Vaccine Against Lyme for Outdoor Recreationists — announced March 23, 2026

Key findings

• Met its primary efficacy endpoint with statistical significance
• Well tolerated across the study population — no safety concerns identified
• Multicenter trial conducted in endemic regions of the U.S., Canada, and Europe
• Enrolled participants aged 5 years and older
• Pfizer is planning regulatory submissions to global authorities

Trial design

VALOR (ClinicalTrials.gov NCT05477524) is a randomized, placebo-controlled, observer-blinded Phase 3 study evaluating the efficacy, safety, and immunogenicity of LB6V. Participants received a 3-dose primary series followed by a booster, with active surveillance for Lyme disease through tick season.