VLA15 is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 and Valneva reported positive interim Phase 1 results in March 2018.
VLA15 is a multivalent vaccine that targets the outer surface protein A (OspA) of Borrelia.
It is designed for prophylactic, active immunization against Lyme disease aiming for protection against the majority of human pathogenic Borrelia species.
VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children.
The target population includes individuals at risk above 2 years of age living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease (as infection with Borrelia does not confer protective immunity against all pathogenic Borrelia species).
On December 17, 2018, Valneva SE announced the initiation of the Phase 2 Clinical Development for its Lyme disease vaccine candidate VLA15.
The overall Phase 2 objective for VLA15 is to determine the optimal dosage level and schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data.
The Phase 2 development for the Lyme disease vaccine candidate will include the evaluation of the highest dose of VLA15 tested in Phase 1 in addition to two higher doses. Furthermore, the company plans to include the evaluation of an additional, alternative three-dose schedule.
Clinical Trial NCT03010228: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis