In a follow-up to the progress made by the French company Valnevas (19459009) Lyme Disease Vaccine VLA15 the company is expected to launch a Phase 2 trial in the second half of 2018, subject to regulatory intervention Permits Phase 1 positive interim results for the vaccine candidate in March 201
Phase 2 to be performed in Lyme endemic regions in the US and Europe These include volunteers previously infected with Borrelia, the bacteria that causes Lyme disease. Further dose and schedule optimizations are considered.
As part of his developmental acceleration strategy, Valneva has decided to add a booster dose to the Phase 1 trial to quickly collect additional data.
A subgroup of subjects in the higher dose groups who received a complete primary immunization schedule (three vaccinations) will be included in a booster extension to assess the safety and immunogenicity of a booster dose of VLA15, approximately 13 months after dosing first immunization is administered. An analysis of safety and immunogenicity is performed after the last person has completed the last study visit six months after the booster dose. In addition, an intermediate analysis of the immunogenicity data will be performed one month after booster.
Lyme disease is the most common and one of the fastest growing vector-borne diseases in the Northern Hemisphere for which there are no other clinical vaccine candidates worldwide.