Lyme Disease Vaccination Gets Fast Track Designation
The company already has plans to initiate a Phase 2 trial as early as the first quarter of 2018.
The Food and Drug Administration (FDA) has granted Fast Track designation to Valneva's Lyme disease vaccine candidate, VLA15.
VLA15 is a protein subunit-based vaccine which targets the Outer Surface Protein A (OspA) of Borrelia, the most dominant protein expressed by the bacteria when present in a tick. Enrollment of 180 subjects in a Phase 1 trial of VLA15 has been completed. The trial will take place at 3 separate sites (2 in the US and 1 in Europe). The primary objective of the trial will be to assess safety and tolerability and different doses.
Additionally, the study will measure immunogenicity against the 6 most prevalent serotypes of Lyme borreliosis present in the vaccine. The company already has plans to initiate a Phase 2 trial as early as the first quarter of 2018.
“We feel privileged to advance the only active clinical stage Lyme vaccine candidate to date and are looking forward to working closely with the FDA and other authorities to facilitate the development towards approval,” said Thomas Lingelbach, CEO of Valneva.
According to the CDC, Lyme disease is the fastest growing vector-borne infectious disease in the US, with an estimated 300,000 individuals developing Lyme disease each year.
Valneva receives FDA fast track designation for its Lyme Disease vaccine candidate VLA15 [press release]. Lyon, France: Valneva SE. Published July 24, 2017. Accessed August 7, 2017.