Valneva SE and Pfizer Inc. announced Monday the 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.
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.”
VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and 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.
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