Lyme Disease Vaccine Advances to Phase III Study

New data from a Phase II clinical trial of Valneva SE and Pfizer Inc.’s Lyme disease vaccine candidate, VLA15, shows it produced strong immune responses, prompting preparations for a Phase III study in the third quarter of 2022. In the trial, VLA15-221 produced stronger responses in adult participants between ages 18 years and 65 years after three priming doses compared to two priming doses. As a result, three-dose priming will be used for adults in the Phase III trial.

“Lyme disease is increasingly impacting people throughout the northern hemisphere, potentially due to environmental changes and more active outdoor lifestyles,” said Kathrin Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer. “The continued positive data from the VLA15-221 trial support the ongoing development of this vaccine candidate, and we look forward to continuing to work with Valneva to potentially help protect people against Lyme disease.”

VLA15, currently the only Lyme disease vaccine candidate in clinical development, targets the outer surface protein A of Borrelia burgdorferi, the bacteria that causes Lyme disease. Its data from the Phase II study supports strong immunogenicity and safety data already demonstrated in previous preclinical and clinical studies. Operating with fast track designation from the U.S. Food and Drug Administration, it has thus far shown an acceptable safety and tolerability profile in adults.

According to Valneva and Pfizer, a separate pediatric study should produce its initial data later this year. That trial is studying the safety and immunogenicity of VLA15 on patients between 5 years and 17 years of age.