VALNEVA AND PFIZER COMPLETE RECRUITMENT FOR PHASE 2 TRIAL OF LYME DISEASE VACCINE CANDIDATEhttps://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-complete-recruitment-phase-2-trial-lymeSaint-Herblain (France) and New York, NY, July 19, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. (NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.
A total of 625 participants, 5 to 65 years of age, have been randomized in the Phase 2 trial to receive VLA15 at Month 0-2-6 or Month 0-6 (200 volunteers each) or placebo at Month 0-2-6 (200 volunteers). The main safety and immunogenicity readout will be performed approximately one month after completion of the primary vaccination schedule (i.e. at Month 7). The objective of the trial is to show safety and immunogenicity down to 5 years of age and to evaluate the optimal vaccination schedule for use in Phase 3.
Since this vaccine is in the middle of Phase 2 testing, approval is probably a couple of years out, assuming Phases 2 and 3 tests go well (as I understand Emergency Use Authorization, this vaccine would not be eligible for that status).
Since Lyme disease is caused by a bacteria, this vaccine obviously does not use traditional dead/weakened/inactivated virus technology. It uses protein subunit technology to "train" the recipients' immune systems to attack a protein in the outer coating of the bacteria.
