Valneva and Pfizer are getting set to launch a new Phase 2 study on VLA-15, their vaccine candidate for Lyme disease.
The study, VLA15-221, builds on previous positive Phase 2 studies. It incorporates new dose regimens and is anticipated to be the final Phase 2 study before deciding to progress into Phase 3 studies.
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study – and is the first of its kind to include a pediatric population, those aged 5-17 years. The study will enroll about 600 healthy participants between the ages of 5 and 65, who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule with a two-dose schedule.
“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,” Kathrin Jansen, head of Pfizer Vaccine Research and Development, said.
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15. It is the only active Lyme disease vaccine candidate currently in clinical development.
“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,” Juan Carlos Jaramillo, chief medical officer of Valneva, said.