Phase 2 Study for Lyme Disease Vaccine Candidate Launches

Officials with Valneva SE have announced initiation of a second phase 2 study for VLA15 to determine optimal dosage levels and vaccination schedule for phase 3 trials of the Lyme vaccine candidate.

VLA15-202, a randomized, observer-blind, placebo controlled trial, will deliver 1 of 2 dosage levels for 250 subjects.

"We are pleased to continue to progress our Lyme vaccine candidate development according to plan and as expeditiously as possible," Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, said in a statement. "The disease footprint is widening and the need for a vaccine to prevent this significant unmet medical need is increasing. With higher dosage levels and the potential alternative vaccination schedule, our ultimate goal is to further optimize our vaccine candidate by targeting a high efficacy from the first Lyme season."

The FDA granted the program Fast Track designation in July 2017.

Reference

Valneva Initiates Second Phase 2 Study for its Lyme Disease Vaccine Candidate VLA15. Valneva. https://valneva.com/press-release/valneva-initiates-second-phase-2-study-for-its-lyme-disease-vaccine-candidate-vla15/. Accessed July 18, 2019.