Valneva, Pfizer Start Phase 2 Study for Lyme Disease Vaccine

 

• The Phase 2 study will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate’s pediatric program

• VLA15 will be tested at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg

• VLA15 is the only Lyme disease vaccine candidate in active clinical development

Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. (NYSE: PFE) today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.

As announced in December 20201, 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 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 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).

https://sports.yahoo.com/valneva-pfizer-announce-initiation-phase-060000252.html