Posted by Michael Wonder on 25 Jul 2017
Valneva receives FDA fast track designation for its Lyme disease vaccine candidate VLA15
24 July 2017 - The company aims to accelerate VLA15’s development and plans to initiate a Phase II trial in Q1 2018.
Valneva today announced that the U.S. FDA has granted fast track designation for its Lyme disease vaccine candidate VLA15.
Valneva recently completed subject enrolment for the ongoing Phase I study of its Lyme disease vaccine candidate. The study is being conducted at three sites – two in the U.S. and one in Europe (Belgium) – combining approximately 180 subjects aged between 18 and 40 years. The primary objective of the observer-blind, partially randomised, dose escalation study is to evaluate the vaccine candidate´s safety and tolerability profile at different dose levels and formulations.
