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.
- Currently the only active vaccine program in clinical development against Lyme disease.
- VLA15 is in Phase 2 clinical development with a clear path to commercialization4
- The overall objective is to determine the optimal dosage level and schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data.
- Valneva expects to announce interim Phase 2 data in 2020.
- The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 20175.
- VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.
Additional information about Lyme disease:
- How many people get Lyme disease? | Lyme Disease | CDC. (n.d.). Retrieved from https://www.cdc.gov/lyme/stats/humancases.html
- 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
- Stanek et al. 2012, The Lancet 379:461–473
- Valneva press release: https://valneva.com/press-release/valneva-initiates-phase-2-clinical-development-for-its-lyme-disease-vaccine-candidate/
- Valneva press release: https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/