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 has 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 (an 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.
Update: As of May 2, 2019, VLA15 is currently in Phase 2 clinical development. The overall objective of the Phase 2 study is to determine the final dose and schedule for use in Phase 3.
In the first quarter of 2019, Valneva reported final Phase 1 data and initial booster data. Overall, the final data confirmed conclusions from the interim data, and the booster evaluations showed a very significant increase in immunogenicity. As circulating antibody levels are important for OspA-based vaccines, higher dosages are being tested in Phase 2, aiming to induce an earlier, higher and more durable immune response.
The ongoing Phase 2 study (VLA15-201) involves 120 subjects and testing of three dosage levels of VLA15, or placebo. Enrolment of subjects for the run-in phase has been completed. Based upon a final review of the run-in safety data by a Data Safety Monitoring Board (DSMB), the two highest safe doses will be taken further into the main study phase.
This dose decision is expected in the second quarter of 2019.
In the main study phase, 450 subjects will receive one of two dose levels of VLA15 (180 subjects each) or placebo (90 subjects).
The DSMB recommendation will also trigger the start of an additional Phase 2 study (VLA15-202) assessing an alternative schedule (0-2-6 months compared to 0-1-2 months).
In this study, approximately 250 healthy volunteers, 18 to 65 years, will receive two selected dose levels, chosen after the run-in phase, or placebo, on the alternative schedule.
The first interim Phase 2 results supporting further progression into Phase 3 are expected mid-2020.
Clinical Trial NCT03010228: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Clinical Trial NCT03769194: A Phase 2 Randomized, Controlled, Observer-blind Study to determine the Immunogenicity and Safety of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years.