Valneva's Lyme disease vaccine candidate - VLA15

The Company is focusing its R&D expertise and resources to a large extend on the development of a much-needed vaccine against Lyme disease, the most common and one of the fastest growing vector-borne illnesses in the Northern Hemisphere for which there is no other clinical vaccine candidate in development worldwide.

Valneva reported positive Phase 1 interim data for its Lyme disease vaccine candidate VLA15 (Press release). The Company has successfully concluded the end of Phase 1 process for this candidate with the Food and Drug Administration (FDA) and has obtained alignment with regard to its Phase 2 strategy (Press release).

Valneva’s Phase 1 study VLA15-101 is an observer-blind, partially randomized, dose escalation trial that aims to evaluate the safety, tolerability and immunogenicity of its Lyme vaccine candidate VLA15. The study enrolled 179 healthy adults under 40 years of age in Europe and the US who were not previously infected with Borrelia burgdorferi.

Valneva is now finalizing the detailed Phase 2 protocol and, subject to requisite regulatory approvals, expects to enter Phase 2 clinical development by the end of 2018.

Valneva´s vaccine candidate VLA15, under Fast Track Designation by the FDA, is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia and intended to protect against the majority of human pathogenic Borrelia species. VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite.

Pre-clinical data showed that this vaccine candidate has the potential for protection against the majority of Borrelia species pathogenic for humans (Source).


The global market for a vaccine against Lyme disease is currently estimated at approximately €700 - €800 million annually1.

About Lyme disease

1 Company estimate supported by independent market studies

18th World Vaccine Congress 2018 - Presentation on Lyme disease
PR Valneva Reports Positive Phase I Interim Results for Its Lyme vaccine candidate VLA15
PR Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15
17th World Vaccine Congress 2017 - Presentation on Lyme disease
Lyme Disease - A Tick-Transmitted Infection (brochure)
PR Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate

Media coverage
Lyme Disease Vaccine Gets Closer To Reality, Interview with Dr. Stanley Plotkin Living Lab Radio, WCAI, 11/06/2018
Prepare for a Bad Summer for Ticks, WSJ, 24/04/2017
Lyme disease is set to explode and we still don’t have a vaccine, New Scientist, 29/03/2017

This program is supported by the Vienna Business Agency.

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