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Valneva, Pfizer Initiate Phase 2 Study For Lyme Disease Vaccine Candidate

Valneva SE announced Monday that the specialty vaccine company and Pfizer Inc. (PFE) have initiated Phase 2 VLA15-221 study for Lyme Disease vaccine candidate.

Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks

VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study, which will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate's pediatric program.

It will be the first VLA15 study to include a pediatric population, aged 5-17 years. Overall, the study will enroll around 600 healthy participants who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule with a two-dose schedule.

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA152. Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10 million from Pfizer to Valneva.

The companies said the VLA15-221 study builds on previous positive Phase 2 studies, and incorporates new dose regimens. It is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.

According to the companies, VLA15 is the only active Lyme disease vaccine candidate in clinical development at present, and covers six serotypes that are prevalent in North America and Europe.

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