In a follow-up on the progress on French company, Valneva’s Lyme disease vaccine candidate VLA15, the company expects to launch a Phase 2 study in the second half of 2018, subject to regulatory clearances, after reporting positive Phase 1 interim data for the vaccine candidate in March 2018.
Phase 2 is intended to be conducted in Lyme-endemic regions in the US and Europe and will include subjects previously infected with Borrelia, the bacteria that causes Lyme disease. Further dose and schedule optimizations are being considered.
As part of its development acceleration strategy, Valneva has elected to augment the Phase 1 study with a booster dose, to gather additional data expeditiously.
A subset of subjects in the higher dose groups who received a complete primary immunization schedule (three vaccinations), will be included in a booster extension to investigate the safety and immunogenicity of a booster dose of VLA15 administered approximately thirteen months after the first immunization. An analysis on safety and immunogenicity will be performed after the last subject has completed the last study visit six months after booster vaccination. In addition, an interim analysis on immunogenicity data one month post booster will be performed.
Lyme disease is the most common and one of the fastest growing vector-borne illnesses in the Northern Hemisphere for which there is no other clinical vaccine candidate in development worldwide.
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