Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate
- 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
Saint-Herblain (France) and New York, NY, March 8, 2021 – 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).
“We are excited to be part of the Lyme disease vaccine development program with Valneva. We hope this Phase 2 trial, with a simplified schedule, will provide evidence that the investigational vaccine can be used in populations that are at risk of contracting Lyme disease, potentially including children age five years and older,” said Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “This trial initiation marks an important step in the development of VLA15 toward a potential licensure. Including a pediatric population in Phase 2 means we could, if successful, add this population to the Phase 3 research program, to potentially offer a vaccine for Lyme disease that may help prevent disease in both adults and children, if approved. We are pleased that, together with our partner Pfizer, we have decided to pursue this development while preparing for a potential Phase 3 start.”
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