Pfizer and Valneva Announce Completion of Lyme Disease Vaccine Trial

Pfizer Inc. and Valneva SE have announced that participants in a phase 3 trial for a vaccine against Lyme disease have completed the primary vaccination series. Valneva's website has the news.

According to Annaliesa Anderson, the senior vice president and head of vaccine research and development at Pfizer, says that VLA15, the vaccine candidate involved in the trial, is “the one which has advanced the furthest along the clinical development timeline, with two phase 3 trials in progress.”

The trial is “a multicenter, placebo-controlled, randomized, observer-blinded trial conducted at sites in areas where Lyme disease is highly endemic across the U.S., Canada, and Europe. The aim of the trial is to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15, a 6-valent OspA-based Lyme disease vaccine candidate. Trial participants aged 5 years and older were randomized 1:1 into two trial groups and receive four doses of either VLA15 or a saline placebo – one dose each at months 0, 2, 5-9 and a booster one year after the third dose, shortly before the peak of the next Lyme disease season.”

So far, no safety concerns have been observed in any treatment group for the VLA15 vaccine. A second phase 3 trial, specifically focused on the pediatric population, is currently ongoing.