Valneva, Pfizer Lyme disease vaccine candidate to enter Phase 3 testing following positive immune showings

Phase 2 testing of a Lyme disease vaccine candidate, VLA15, produced strong immune responses, according to the newest data from Valneva SE and Pfizer inc, prompting preparations for a Phase 3 study in the third quarter of 2022.

The VLA15-221 trial produced stronger responses in adult participants – those between ages 18 and 65 years old – after three priming doses compared to two priming doses. As a result, three-dose priming will be used for adults in the Phase 3 trial. A separate pediatric study should produce its initial data later this year.

“Lyme disease is increasingly impacting people throughout the northern hemisphere, potentially due to environmental changes and more active outdoor lifestyles,” said Dr. Kathrin Jansen, senior vice president and head of Vaccine Research & 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 is currently the only Lyme disease vaccine candidate in clinical development. It targets the outer surface protein A of Borrelia burgdorferi, the bacteria that causes Lyme disease. Its data from the Phase 2 study supports strong immunogenicity and safety data already demonstrated in previous pre-clinical and clinical studies. Operating with Fast Track designation from the U.S. Food and Drug Administration (FDA), it has thus far shown an acceptable safety and tolerability profile in adults.

“I’m very pleased with these results, which are critical for determining the optimal vaccination schedule for our planned Phase 3 trial,” Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said. “In partnership with Pfizer, we are excited to further investigate this vaccine candidate, which will hopefully help provide protection against Lyme disease for both adults and children.”

The ongoing pediatric trial is studying the safety and immunogenicity of VLA15 on patients between 5-17 years old. The placebo-controlled, randomized Phase 2 study of adults included 294 healthy participants.