Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva.
The Vaccine Against Lyme for Outdoor Recreationists (VALOR) trial will investigate the efficacy, safety and immunogenicity of Pfizer and Valneva’s Lyme disease vaccine candidate, VLA15.
The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. Participants will receive three doses of VLA15 or a saline placebo, followed by a booster dose.
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. It works by targeting the outer surface protein A (OspA) of the bacteria that cause Lyme disease. It’s thought that by blocking OspA, this will inhibit the bacterium’s ability to leave the tick and infect humans.
Data from Phase II studies of VLA15 show the candidate has strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations.1,2
If the Phase III trial is successful, Pfizer aims to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.
“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,” said Annaliesa Anderson, Senior Vice President and Head of Vaccine Research & Development at Pfizer. “We hope that the data generated from the Phase III study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the US and Europe on this important trial.”
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are extremely pleased to reach this important milestone in the development of VLA15. 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 III, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.”
1: Valneva. Valneva Pfizer Report Positive Phase 2 Pediatric Data for Lyme Vaccine Candidate. April 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/Accessed: July 2022.
2: Valneva. Valneva Pfizer Report Positive Phase 2 Data for Lyme Disease Vaccine Candidate. February 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-data-for-lyme-disease-vaccine-candidate/Accessed: July 2022