Valneva SE announced positive immunogenicity and safety data from the ongoing Phase 2 study of Lyme disease vaccine candidate, VLA15. The strong anamnestic immune response and favorable safety profile following a third booster dose were consistent with those reported after receiving previous annual booster doses further demonstrating compatibility with the anticipated benefits of a yearly vaccination prior to each Lyme season.
There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest in clinical development, with two Phase 3 trials nearing completion. The Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year, and 132,000 cases are reported annually in Europe. Vaccination has been completed in the pivotal Phase 3 study of VLA155, and subject to positive data, Pfizer aims to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These latest data further reinforce the potential benefits of booster doses across all evaluated age groups. There are currently no approved human vaccines for Lyme disease, and as the disease continues to expand geographically, it remains a pressing unmet medical need affecting communities across the Northern Hemisphere. Each set of positive results moves us closer to the possibility of making this vaccine available to both adults and children living in Lyme-endemic areas.”
These latest results from the VLA15-221 Phase 2 study - measured one month after vaccination at month 42 - again demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine candidate in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age). A high proportion of participants seroconverted after the third booster dose, yielding seroconversion rates* (SCRs) at 100% (confidence interval 96.7%, 100%) for all outer surface protein A (OspA) serotypes in all age groups, in-line with SCRs after the first and second booster. Geometric Mean Titers at one month post first and second booster (i.e. month 19 vs. month 31) were comparably high.
The safety and tolerability profile of VLA15 after the third booster dose was similar to the profile observed after the previous booster doses. To date, no safety concerns have been observed by the independent DMC in any treatment or age group.
Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization by Pfizer of VLA15.
Participants in this Phase 2 study received VLA15 or placebo during the primary vaccination phase in two immunization schedules (month 0-2-6 or month 0-6), followed by yearly vaccinations at months 18, 30 and 42. In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in North America and Europe.6 Dosing of all subjects was recently completed as announced by Pfizer. A second Phase 3 trial (C4601012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population between 5 and 17 years of age also completed vaccination.
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