Valneva's Lyme disease
vaccine candidate - VLA15
Valneva has developed a multivalent, protein subunit based vaccine candidate against Lyme disease.
Following clearance from the Food & Drug Administration (FDA) and the Belgian authorities, Valneva initiated a Phase I trial in the US and Europe in 2016 with the primary objectives of evaluating safety and tolerability. Immunogenicity
against six OspA serotypes will also be monitored for different dose groups and formulations.
Valneva recently completed subject enrollment for the ongoing Phase I study of its Lyme disease vaccine candidate and initiated serological testing. Valneva expects to announce Phase I data in the first quarter of 2018 which will be immediately followed by Phase II launch. The Phase I 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.
In July 2017, Valneva received FDA Fast Track Designation for its Lyme Disease vaccine candidate VLA15. In 2017, the Company will advance the Phase I trials of its Lyme vaccine candidate and endeavors to accelerate the progression of the program towards Phase II.
Pre-clinical data showed that this vaccine candidate has the potential for protection against the majority of Borrelia species pathogenic for humans (Source
This program is supported by the Vienna Business Agency.