Valneva and Pfizer begin Phase 2 study for Lyme disease vaccine

March 11, 2021

Pfizer announced that they and Valneva will begin a Phase 2 study of Lyme disease vaccine, which will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate’s pediatric program.            

The companies said the vaccine, VLA15, is the only Lyme disease vaccine candidate in active clinical development, and it covers six serotypes that are prevalent in North America and Europe. This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

As announced in December, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It will be the first VLA15 study to include a pediatric population (aged 5 to 17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5 to 65 years) who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6).

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA152. Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10million from Pfizer to Valneva.

Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks.

Pfizer has the release