Valneva and Pfizer Announce Positive Phase 2 Booster Results for Lyme Disease Vaccine

SAINT-HERBLAIN, France and NEW YORK, NY, USA — September 3, 2024 — Valneva SE and Pfizer Inc. have shared positive results from their VLA15-221 Phase 2 study, focusing on their Lyme disease vaccine candidate, VLA15. The study evaluated the immunogenicity and safety one month following a second booster dose, given a year after the initial booster. The immune response and safety profile were consistent with those observed after the first booster, supporting the anticipated benefits of annual booster vaccinations before each Lyme season.

Currently, no human vaccines for Lyme disease are available. VLA15 is the most advanced Lyme disease vaccine candidate in clinical development, with two Phase 3 trials underway. 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 annually, with Europe reporting about 129,000 cases each year.

The VLA15-221 Phase 2 study results showed a significant anamnestic antibody response across all six serotypes targeted by the vaccine in various age groups, including pediatric (5 to 11 years), adolescent (12 to 17 years), and adult (18 to 65 years) participants. One month after the second booster dose, seroconversion rates (SCRs) exceeded 90% for all outer surface protein A (OspA) serotypes across all age groups, aligning with SCRs after the first booster. Geometric Mean Titers were high one month post-first and second booster doses.

Participants in this Phase 2 study received VLA15 or a placebo during the primary vaccination phase, adhering to two immunization schedules (month 0-2-6 or month 0-6). They then received a first booster dose at month 18 and a second at month 30.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, emphasized the encouraging data, highlighting the potential benefits of booster doses across all age groups. He noted that Lyme disease continues to spread, representing a significant unmet medical need in the Northern Hemisphere. Each new set of positive data advances the goal of making the vaccine available to those in Lyme-endemic areas.

The safety and tolerability profile of VLA15 after the second booster was similar to the first, with no safety concerns observed by an independent Data Monitoring Committee (DMC) across treatment or age groups.

Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, noted that these data mark an important step towards developing a vaccine to protect against Lyme disease. Emphasizing the importance of preventive behaviors, she sees the VLA15-221 study data as a key progression towards easing the burden of Lyme disease.

In August 2022, Pfizer and Valneva began the ongoing Phase 3 clinical trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to evaluate the efficacy, safety, and immunogenicity of VLA15 in participants aged five and older in highly endemic regions in the U.S. and Europe. The primary vaccination series for all participants was completed in July 2024. A second Phase 3 study, VLA15-1012, is also ongoing, focusing on the safety profile in the pediatric population.

Pfizer intends 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 Phase 3 data.

VLA15 is an investigational multivalent protein subunit vaccine targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease. OspA is expressed by the bacteria in ticks, and blocking it prevents the bacteria from infecting humans. The vaccine candidate addresses six prevalent OspA serotypes found in North America and Europe.

The VLA15-221 study is a randomized, observer-blind, placebo-controlled Phase 2 trial and the first to enroll a pediatric population (5-17 years old). It included 560 healthy participants who received either VLA15 in two immunization schedules or a placebo. The main safety and immunogenicity readout was performed one month after completing the primary vaccination series. Eligible participants received booster doses at months 18 and 30 and will be followed for an additional year to monitor antibody persistence. A further booster dose at month 42 will assess the effect of periodic booster doses.

Lyme disease is a systemic infection caused by Borrelia burgdorferi, transmitted via infected Ixodes ticks. It is the most common vector-borne illness in the Northern Hemisphere. Early symptoms, such as a gradually expanding rash (erythema migrans), fatigue, fever, headache, mild stiff neck, and muscle and joint pains, are often overlooked. If untreated, the disease can lead to chronic complications affecting the skin, joints, heart, or nervous system. The need for a Lyme disease vaccine is increasing as the disease's geographic footprint expands.

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