Phase 3 study gathering 6,000 to trial Pfizer, Valneva Lyme disease vaccine candidate

Pfizer Inc. and Valneva SE this week started a Phase 3 clinical study — Vaccine Against Lyme for Outdoor Recreationists (VALOR) — to study the efficacy, safety and immunogenicity of a Lyme disease vaccine candidate known as VLA15.

Currently, VLA15 is the only Lyme disease vaccine undergoing clinical development. The trial will gather approximately 6,000 participants from 5 years old and up across regions where the disease is endemic, in both Europe and the U.S. It will be randomized, placebo-controlled and spread across up to 50 sites.

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” Dr. Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial.”

Participants will be given three, 180 µg doses of either VLA15 or saline placebo as a primary vaccination series, followed by a single booster of the same. If the study is successful — and data from Phase 2 studies indicate that in terms of safety and tolerability, it should do well — Pfizer could submit both a Biologics License Application to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application to the European Medicines Agency (EMA) in 2025.

“We are extremely pleased to reach this important milestone in the development of VLA15,” Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, said. “Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere. We look forward to further investigating the VLA15 candidate in Phase 3, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.”

As part of the collaboration between the two companies, the beginning of the Phase 3 study will also herald a $25 million milestone payment from Pfizer to Valneva.