Lyme disease is the most common vector-borne illness in the Northern Hemisphere1,2. It is caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks3. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 300,000 Americans are diagnosed with Lyme disease each year with at least a further 200,000 cases in Europe1,2.

VLA15 – Valneva’s Lyme disease vaccine candidate

  • VLA15 is currently the only active vaccine program in clinical development against Lyme disease.
  • VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common pathogenic strains found in the United States and Europe.
  • Valneva has completed recruitment and reported initial results for two Phase 2 clinical trials [4,5] of VLA15 in over 800 healthy adults and in which Valneva observed high levels of antibodies against all six serotypes.
  • Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 [6].
  • As part of its collaboration with Pfizer, Valneva announced in December 2020 [7], that it had accelerated the pediatric development of VLA15 with an additional Phase 2 clinical trial initiated in March 2021.
  • The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 [8].

Additional information about Lyme disease:

  1. How many people get Lyme disease? | Lyme Disease | CDC. (n.d.). Retrieved from https://www.cdc.gov/lyme/stats/humancases.html
  2. Estimated from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed; ECDC tick-borne-diseases- meeting-report
  3. Stanek et al. 2012, The Lancet 379:461–473
  4. Valneva press release: Valneva Announces Positive Initial Results for Phase 2 Study of Lyme Disease Vaccine Candidate
  5. Valneva press release: Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15
  6. Valneva press release: Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15
  7. Valneva press release: Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate
  8. Valneva press release: Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15