Valneva gets approvals to start clinical testing of lyme disease vaccine candidate

The move follows the Investigational New Drug application (IND) clearance from the US Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).

Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection that can cause serious health problems and disabilities. Each year, an estimated 300,000 Americans and 85,000 Europeans develop Lyme disease and according to the CDC (Centers for Disease Control and Prevention), it is the fastest growing vector-borne infectious disease in the United States.

Valneva is developing 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. Pre-clinical data showed that Valneva's vaccine candidate can provide protection against the majority of Borrelia species pathogenic for humans.

Valneva president and CEO Thomas Lingelbach and Valneva deputy CEO Franck Grimaud said: "We are very pleased to be able to advance our Lyme vaccine candidate which is intended to address such an important unmet medical need. 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."

Valneva's Phase I trial VLA15-101 is being conducted at two sites – one in the U.S. and one in Europe (Belgium)  and will enroll 180 subjects, aged 18-40 years.

The primary objective of the single-blind, partially randomized, dose escalation study will be to evaluate the product candidate's safety and tolerability.

Immunogenicity, measured by observing IgG antibodies specific against six OspA serotypes, will also be monitored for different dose groups and formulations at different time-points.