Two Phase 2 Clinical Trials of Lyme Disease Vaccine Candidate Published

Syringe on Lyme green backgroundBiospace (6.3.2024) published a news release, “Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases.” Two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in The Lancet Infectious Diseases, a peer-reviewed medical journal. This announcement was made by Valneva, a specialty vaccine company that has been working on development of a Lyme vaccine. Valneva announced that these trials, as well as a third Phase 2 trial in pediatric participants, support the design of Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists’ (VALOR).

The Lancet Infectious Diseases article, “Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies” presents analysis of the VLA15-201 and VLA15-202 trial results. These trials investigated various dose levels and vaccination schedules of VLA15. VLA15 is a hexavalent Lyme disease vaccine candidate targeting the six of the most prevalent Borrelia species in North America and Europe.

VLA15 produced an immune response across all dose groups and vaccination schedules that were tested, though the antibody responses across all six serotypes were strongest at the highest dose (180 µg) and broader vaccination intervals (Month 0,2,6). Favorable safety and tolerability of VLA15 has been observed across all trials to date.

In April 2020, Valneva and Pfizer entered into an agreement co-develop VLA15. Updates to the terms of this agreement were made in June 2023. Positive results for the booster phase of trial VLA15-2024 and a third Phase 2 trial, VLA15-2215, were previously reported by the companies which provide additional information the safety profile of VLA15. These trials also showed results with potential to provide immunity against Lyme disease in adult, pediatric and adolescent populations. The results of these studies are anticipated to be published by Valneva and Pfizer in a peer-reviewed medical journal in the future.

VALOR, the Phase 3 clinical trial, is ongoing. This trial aims to investigate the “efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada and Europe.” The 9,437 participants for the trial were enrolled by December 2023.

VLA15 has advanced the furthest of any Lyme vaccine candidates currently in clinical development, with two Phase 3 trials in progress. This vaccine candidate targets the outer surface protein A (OspA) of Borrelia burgdorferi. OspA blocking prevents the bacterium’s ability to leave the tick and infect humans. VLA15 covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe. Pfizer plans to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive data in these last trials.

For More Information: 

Read the Biospace Article

Read the Valneva News Release

Read The Lancet Infectious Diseases Article

Read Other LDA Articles on Vaccine Development