Valneva SE, a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, Monday announced that it has completed patient recruitment of the Phase 2 studies for its Lyme disease vaccine candidate, VLA15.

Borrelia burgdorferi spirochetes/CDC

A total of 819 subjects have been recruited for Phase 2 development in two ongoing studies. The results of these studies, comprising immunogenicity and safety data, will support the dose and vaccination schedule to be used in Phase 3.

Study VLA15-201 includes 573 subjects across nine sites in Europe and the U.S. Study VLA15-202 includes 246 subjects across five sites in the U.S. In both studies, dosage levels of 135µg and 180µg of VLA15 are used and administered either at Day 1, Month 1 and Month 2 (VLA15-201) or at Day 1, Month 2 and Month 6 (VLA15-202).

Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, “We are extremely pleased that all Phase 2 subjects have been recruited as planned and on target. We are making great progress in developing our Lyme disease vaccine candidate with the aim of addressing this significant unmet medical need. I would also like to thank our internal teams as well as our CROs and study sites for their dedication and commitment to achieve the subject recruitment on time. We are looking forward to our initial Phase 2 results in mid 2020.”