Lyme Disease Vaccine Candidate Advances
France-based Valneva SE and Pfizer Inc. announced the initiation of another Lyme Disease vaccine study, VLA15-221. This study will build on previous positive Phase 2 studies, incorporate new dose regimens, and anticipate the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.
VLA15 is the only active Lyme disease vaccine candidate in clinical development as of March 8, 2021, and covers six serotypes prevalent in North America and Europe. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far.
As announced in December 2020, VLA15-221 will be the first VLA15 study to include a pediatric population. Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6) or placebo.
“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,” stated Kathrin Jansen, SVP and Head of Pfizer Vaccine Research and Development, in a press statement.
Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere, according to the U.S. Centers for Disease Control and Prevention.
Valneva SE is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs.