Valneva Publishes Lyme Disease Phase 2 Trials in Lancet Infectious Diseases

Valneva SE, a specialty vaccine company, recently announced the publication of results from two Phase 2 clinical trials of their Lyme disease vaccine candidate, VLA15, in The Lancet Infectious Diseases. These trials, along with a third Phase 2 study involving pediatric participants, have shaped the design of the ongoing pivotal Phase 3 trial named ‘Vaccine Against Lyme for Outdoor Recreationists’ (VALOR).

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, expressed satisfaction that these findings are now accessible to the infectious disease community. He highlighted Lyme disease as the most common vector-borne illness in both North America and Europe and emphasized the importance of the ongoing trials in addressing this significant medical need.

The article, titled “Optimization of Dose Level and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies,” details the outcomes of trials VLA15-201 and VLA15-202. These studies explored various dose levels and vaccination schedules of VLA15, a hexavalent vaccine targeting six prevalent Borrelia species serotypes in North America and Europe. The findings revealed that VLA15 was immunogenic across all tested doses and schedules, with the highest dose (180 µg) and broader intervals (Month 0, 2, 6) eliciting the strongest antibody responses. Importantly, VLA15 demonstrated a favorable safety and tolerability profile, with no safety concerns reported by an independent Data Safety Monitoring Board.

Valneva and Pfizer have been collaborating on the development of VLA15 since April 2020, with an updated agreement in June 2022. Positive booster phase results from trial VLA15-202 and a third Phase 2 trial (VLA15-221) further confirmed VLA15’s safety and potential efficacy in providing immunity against Lyme disease across adult, pediatric, and adolescent populations. These findings are also set to be published in a peer-reviewed journal.

The ongoing Phase 3 trial, VALOR, aims to evaluate the efficacy, safety, and immunogenicity of VLA15 in participants aged five years and older across highly endemic regions in the United States, Canada, and Europe. Enrollment of 9,437 participants was completed in December 2023. If the data from this trial are positive, Pfizer plans to submit regulatory applications to the Food and Drug Administration and the European Medicines Agency in 2026.

There are currently no approved vaccines for Lyme disease in humans. VLA15 is the most advanced Lyme disease vaccine candidate in clinical development, with two Phase 3 trials underway. This investigational vaccine uses a well-established mechanism targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria responsible for Lyme disease. By blocking OspA, the vaccine prevents the bacteria from leaving the tick and infecting humans. VLA15 covers the six most prevalent OspA serotypes of Borrelia burgdorferi sensu lato species in North America and Europe.

Lyme disease is a systemic infection caused by Borrelia burgdorferi and transmitted through the bite of infected Ixodes ticks. It is the most common vector-borne disease in the Northern Hemisphere, with an estimated 476,000 people diagnosed annually in the U.S. and 129,000 cases reported each year in Europe. Early symptoms, such as the erythematous rash Erythema migrans, fatigue, fever, headache, and joint pains, are often overlooked. If left untreated, Lyme disease can lead to serious chronic complications affecting the skin, joints, heart, and nervous system. The need for a vaccine is increasing as the disease's geographic spread widens.

Valneva SE specializes in developing, manufacturing, and commercializing vaccines for infectious diseases with unmet medical needs. The company has a successful track record, having advanced multiple vaccines from R&D to approval and currently markets three proprietary travel vaccines. Valneva’s collaboration with Pfizer on VLA15 represents a significant step forward in addressing the growing public health threat of Lyme disease.