Valneva reports Phase I data for Lyme disease vaccine candidate

Valneva SE (Euronext Paris:VLA; VSE:VLA) reported interim data from a Phase I trial in 179 healthy volunteers ages 18-40 showing that Lyme disease candidate VLA15 (VLA15-101) met the primary endpoint by achieving a "favorable" safety profile. Subjects received 12, 48 or 90 μg doses of VLA15 with or without alum adjuvant on days 0, 28 and 56. VLA15 is a hexavalent recombinant Borrelia outer surface protein A (ospA) vaccine.

On the secondary immunogenicity endpoint, Valneva said ospA-specific IgG responses were observed in all treatment arms and against all ospA serotypes, and that VLA15 was more immunogenic in patients receiving adjuvanted VLA15 vs. non-adjuvanted VLA15. Additionally, IgG levels for all ospA serotypes were higher after three immunizations at day 84 compared with after two immunizations at day 56. For patients receiving 90 μg VLA15 plus alum, seroconversion rates ranged from 71.4-96.4% for the different ospA serotypes. Final safety and immunogenicity data, including one year follow-up data, are expected in early 2019...