FDA: Valneva To Begin Clinical Testing of Lyme Disease Vaccine
The phase I trial of VLA15-101 is being conducted at 1 site in the US and 1 in Belgium.
Valneva announced that its Lyme disease vaccine candidate, VLA15, is progressing into Phase 1 clinical testing.1
VLA15 is a new hexavalent, protein subunit-based vaccine targeting the Outer Surface Protein A (OspA) of Borrelia. OspA is one of the most dominant proteins expressed by the bacteria when present in a tick.
The decision to start clinical testing comes after the Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND). The Phase I trial VLA15-101 is being conducted at 2 sites—1 in the US and 1 in Belgium and will enroll 180 subjects, aged 18 to 40 years. The primary objective of the single-blind, partially randomized, dose escalation study will be to evaluate the candidate's safety and tolerability.
“We are committed to finding ways to accelerate the clinical development path to licensure, given that we are conducting the only active vaccine program in the industry,” said Thomas Lingelbach, president and CEO of Valneva.
There is no current vaccine available to protect against Lyme disease, which affects an estimated 300,000 American's each year according to the Centers for Disease Control and Prevention.
For more information visit Valneva.com.
- Valneva receives FDA and European approvals to start clinical testing of Lyme disease vaccination [news release]. Lyon, France: Valneva SE. Published December 9, 2016. Accessed December 16, 2016.