Lyme Disease – VLA15

Lyme disease is the most common vector-borne disease in the Northern Hemisphere1. It is caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks2. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year with at least a further 130,000 cases in Europe3,4.

VLA15 – Valneva’s Lyme disease vaccine candidate

  • VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development.
  • The placebo-controlled Phase 3 study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), investigates the efficacy, safety and immunogenicity of VLA15 in participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
  • 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.
  • Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations [6,7]. In September 2023, Valneva and Pfizer reported positive pediatric and adolescent immunogenicity and safety data for VLA15, when given as a booster [8]
  • Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms in June 2022 [5].
  • Pfizer is currently aiming to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive Phase 3 data. [9]
  • The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 [10].

Additional information about Lyme disease:

Valneva’s press releases about VLA15

  1. Lyme borreliosis in Europe: influences of climate and climate change, epidemiology, ecology and adaptation measures (2006), Retrieved from https://www.euro.who.int/__data/assets/pdf_file/0006/96819/E89522.pdf, Accessed 02-Oct-2021
  2. Stanek et al. 2012, The Lancet 379:461–473
  3. Center for Disease Control and Prevention. Lyme Disease. Data and Surveillance. April 2021. Available at: https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html Accessed July 2022.
  4. Sykes RA, et al. An estimate of Lyme borreliosis incidence in Western Europe. Journal of Public Health 2017; 39(1): 74-81
  5. Valneva press release: Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15, Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
  6. Valneva press release: Valneva Announces Positive Initial Results for Phase 2 Study of Lyme Disease Vaccine Candidate
  7. Valneva press release: Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15
  8. Valneva press release: Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate
  9. Valneva press release: Valneva Reports First Quarter 2023 Financial Results and Provides Corporate Updates
  10. Valneva press release: Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15