Pfizer and Valneva Start Mid-Stage Trial Evaluating Lyme Disease Vaccine

Pfizer and French drugmaker Valneva have initiated a new phase 2 study evaluating VLA15, their experimental vaccine for Lyme disease — and say this is likely to be the last one before the candidate progresses to phase 3 trials.

VLA15 is the “only active Lyme disease vaccine candidate in clinical development” and has shown both strong immunogenicity and a positive safety profile based on data from previous trials, the companies said.

The randomized, placebo-controlled phase 2 study will enroll an estimated 600 participants ages five to 65 and will compare a two-dose and a three-dose regimen.

The study’s launch comes almost a year after Pfizer and Valneva teamed up to co-develop VLA15, with Pfizer paying Valneva up to $308 million in cash payments, excluding royalties on future sales.