Valneva SE announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ?Vaccine Against Lyme for Outdoor Recreationists? (VALOR).

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? provides a detailed analysis of the VLA15-201 and VLA15-202 trial results, which investigated different dose levels and vaccination schedules of VLA15, a hexavalent Lyme disease vaccine candidate targeting most prevalent Borrelia species (serotype 1-6) in North America and Europe. VLA15 was shown to be immunogenic across all dose groups and vaccination schedules tested.

Strongest antibody responses across all six serotypes were exhibited at the highest dose (180 µg) and broader vaccination intervals (Month 0,2,6). VLA15 has shown a favorable safety and tolerability profile across all trials to date. No safety concerns were observed by an independent Data Safety Monitoring Board (DSMB)1,2, in any treatment group.

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 20223. The companies previously reported positive results for the booster phase of trial VLA15-2024 and a third Phase 2 trial, VLA15-2215, providing further evidence on VLA15?s safety profile and its potential to provide immunity against Lyme disease in adult, pediatric and adolescent populations. The companies also aim to publish these results in a peer-reviewed medical journal.

The Phase 3 clinical trial, VALOR, is currently ongoing 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. Enrollment of 9,437 participants for the trial was completed in December 2023. Subject to positive data, Pfizer aims to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.