Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) reported positive immunogenicity and safety data from its ongoing Phase 2 clinical trial evaluating its Lyme disease vaccine candidate, VLA15. The study, VLA15-221, assessed the effects of a third annual booster dose.
The data demonstrated a robust immune response and maintained a positive safety profile consistent with previous booster doses. This supports the potential benefits of yearly vaccination before each Lyme season.
The results, measured one month after the third booster (month 42), showed a significant antibody response across all six serotypes targeted by the vaccine in children (ages 5 to 17) and adults (ages 18 to 65). Seroconversion rates reached 100% for all outer surface protein A (OspA) serotypes across all age groups, mirroring the rates observed after the first and second boosters.
An independent Data Monitoring Committee (DMC) reported no safety concerns in any age group or treatment arm. The safety profile following the third booster remained consistent with previous doses.
Juan Carlos Jaramillo, Valneva‘s Chief Medical Officer, highlighted the significance of these results, emphasizing the unmet medical need for a Lyme disease vaccine given the disease’s increasing geographic spread. He stated that this progress brings the possibility of making the vaccine available to affected communities closer to reality.
Pfizer and Valneva, who collaborate on the development and commercialization of VLA15, aim to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, pending positive data from ongoing Phase 3 trials.
Two Phase 3 trials are underway: the VALOR study (NCT05477524) and another trial focused on the safety profile in children aged 5 to 17. Both trials have recently completed dosing. The VALOR study investigates efficacy, safety, and immunogenicity in highly endemic regions of North America and Europe.
VLA15 is a multivalent protein subunit vaccine targeting OspA, a surface protein of the Borrelia burgdorferi bacteria, the causative agent of Lyme disease. By targeting OspA, the vaccine aims to prevent the bacteria from infecting humans. The vaccine covers the six most common OspA serotypes in North America and Europe.
The VLA15-221 Phase 2 study was a randomized, placebo-controlled trial. It enrolled 560 participants who received either VLA15 or a placebo, with yearly boosters given at months 18, 30, and 42. The study included both participants with prior Borrelia burgdorferi infection and those without.
Lyme disease is a vector-borne illness spread by infected ticks. While the exact incidence is unknown, estimates suggest hundreds of thousands of cases
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