Pfizer Completes Trial Enrollment for Lyme Disease Vaccine

Pfizer and Valneva recently completed recruitment for the Phase 2 clinical trial of Lyme disease vaccine candidate, VLA15. 

The trial, VLA15-221, builds on previous positive Phase 2 trials and includes 625 adult and pediatric participants aged five to 65 years of age to support the acceleration of the vaccine candidate’s pediatric program. 

Participants will receive VLA15 at Month 0-2-6 or Month 0-6 (200 participants each) or placebo at Month 0-2-6 (200 volunteers). 

The trial aims to show safety and immunogenicity down to five years of age and evaluate the optimal vaccination schedule for use in Phase 3. The readout will be about one month after completion of the primary vaccination schedule, a Pfizer spokesperson said. 

“Given the medical importance of Lyme disease, its possible long term impact, and the known mechanism of vaccine protection, the development of a multivalent vaccine for prevention of 6 serotypes of Borrelia has the potential to address a great unmet need,” Kathrin Jansen, PhD, senior vice president and head of Pfizer Vaccine Research and Development, said in the announcement. 

“We are pleased that the Phase 2 trial has reached full recruitment and look forward to what we hope will be a successful conclusion of the study,” Jansen continued. 

VLA15 was granted FDA Fast Track designation in July 2017.

The program is currently the only active Lyme disease vaccine program in clinical development and covers six serotypes prevalent in North America and Europe. So far, the vaccine has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies.

VLA15 uses a mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. 

OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick, a Pfizer spokesperson explained. 

Pfizer and Valneva first entered into a collaboration to develop and commercialize VLA15 in April 2020. 

Under the terms of the agreement, Valneva is eligible to receive a total of $308 million cash payments consisting of a $130 million upfront payment, $35 million in development milestones, and $143 million in early commercialization milestones. 

Valneva will also fund 30 percent of all development costs through completion of the development program, while Pfizer will pay Valneva tiered royalties starting at 19 percent. 

Pfizer will lead late-stage development and have sole control over-commercialization.