VLA15 is a multivalent Lyme Disease vaccine candidate 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.
The VLA15 Lyme disease vaccine 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.
VLA15 is administered as intramuscular injections on Day 1, Day 57 and Day 180.
The VLA15 vaccine 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.
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).
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.
July 1, 2019: A second Phase 2 clinical trial for the development of Lyme disease vaccine candidate VLA15 has been announced.
June 12, 2019: An independent Data Safety Monitoring Board (DSMB) has cleared two dosage levels to be used for clinical development.
Clinical Trial NCT03970733: The objectives for this Phase 2 VLA15-202 clinical study are to determine the optimal dosage level and vaccination schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data.
A total of 250 subjects will be randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (two different dose levels) or Placebo.
Study duration per subject will be a maximum of 19 months. Overall study Duration is estimated to be 21 months.
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.
This 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.