Valneva Reports Positive Phase 2 Data For Lyme Disease Vaccine Candidate VLA15

Valneva SE, today announced positive immunogenicity and safety data from its ongoing Phase 2 study of VLA15, the only Lyme disease vaccine candidate in advanced clinical development. Results demonstrated a robust anamnestic immune response and a favorable safety profile following a third booster dose, consistent with earlier annual boosters. These findings support the potential benefit of yearly vaccination prior to each Lyme season.

Key findings include 100% seroconversion rates (CI: 96.7%–100%) were observed across all six OspA serotypes and age groups (pediatric, adolescent, adult). High antibody titers were maintained, with levels comparable across the first and second booster doses. Safety profile after the third booster was consistent with earlier doses, with no safety concerns identified by the independent Data Monitoring Committee (DMC).

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These latest data further reinforce the potential benefits of booster doses across all evaluated age groups. There are currently no approved human vaccines for Lyme disease, and as the disease continues to expand geographically, it remains a pressing unmet medical need affecting communities across the Northern Hemisphere. Each set of positive results moves us closer to the possibility of making this vaccine available to both adults and children living in Lyme-endemic areas.”

VLA15 is being co-developed with Pfizer under a collaboration established in 2020. The candidate has advanced furthest in clinical development, with two Phase 3 trials nearing completion: VALOR (NCT05477524): Large-scale Phase 3 trial assessing efficacy, safety, and immunogenicity in participants ≥5 years in endemic regions across North America and Europe. Dosing of all subjects has recently been completed. C4601012 trial: Phase 3 safety study in pediatric patients (ages 5–17), also fully enrolled and vaccinated.

If successful, Pfizer expects to submit a Biologics License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in 2026. With an estimated 476,000 U.S. cases and 132,000 European cases of Lyme disease annually.