Merck Announces Results from 2 Phase 3 Studies on its Pneumococcal Conjugate Vaccine
The investigational vaccine was regarded as well-tolerated and elicited an immune response.
Merck announced yesterday that V114, its investigational 15-valent pneumococcal conjugate vaccine, met its primary objectives. These results come from 2 phase 3 studies, which evaluated the safety, tolerability, and immunogenicity of the vaccine.
“Continued scientific innovation in pneumococcal disease prevention is needed to target the serotypes that pose the greatest risk to specific populations while maintaining immune response as new serotypes are added. These Phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said.
The V114 vaccine is in development for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.
One of the 2 phase 3 studies was the PNEU-AGE (V114-019) trial, which enrolled healthy adults 50 years of age or older. The trial demonstrated the vaccine was non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13.
These results are based on opsonophagocytic activity (OPA) responses—a measure of vaccine-induced functional antibodies. This study also met the key secondary immunogenicity objective, demonstrating superiority of V114 compared to PCV13 for serotype 3, a leading cause of invasive pneumococcal disease.
The company’s other phase 3 trial, PNEU-TRUE (V114-020), also used healthy adults 50 years of age or older. The vaccine met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114.
In both studies, the vaccine was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies.
These findings and additional Phase 3 data from the company’s clinical program, will be used as evidence for Merck’s global regulatory licensure applications. The company plans to apply for US Food and Drug Administration (FDA) approval before the end of 2020.