VLA15 is a multivalent vaccine that targets the outer surface protein A (OspA) of Borrelia and is under Fast Track Designation by the Food and Drug Administration (FDA).
On December 17, 2018, Valneva SE announced the initiation of the Phase 2 Clinical Development for its Lyme disease vaccine candidate VLA15.
The study will investigate the safety and tolerability as well as immunogenicity of VLA15. The primary objective addresses safety and tolerability of the vaccine up to three months after enrollment, i.e. 84 days after first vaccination. The study includes 1 screening visit and 8 outpatient visits from day 0 through day 365.