logo
Plus   Neg
Share
Email

Valneva, Pfizer Initiate Phase 2 Study For Lyme Disease Vaccine Candidate

Valneva SE announced Monday that the specialty vaccine company and Pfizer Inc. (PFE) have initiated Phase 2 VLA15-221 study for Lyme Disease vaccine candidate.

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

VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study, which will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate's pediatric program.

It will be the first VLA15 study to include a pediatric population, aged 5-17 years. Overall, the study will enroll around 600 healthy participants who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule with a two-dose schedule.

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 $10 million from Pfizer to Valneva.

The companies said the VLA15-221 study builds on previous positive Phase 2 studies, and incorporates new dose regimens. It is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.

According to the companies, VLA15 is the only active Lyme disease vaccine candidate in clinical development at present, and covers six serotypes that are prevalent in North America and Europe.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT