Novel Pneumococcal Conjugate Vaccine Immunogenic in Phase 3 Trials

Results from PNEU-PATH demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in V114.

Merck announced positive topline results from 2 additional phase 3 studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease in adults.

The multicenter, randomized, double-blind, active comparator-controlled phase 3 studies, PNEU-PATH and PNEU-DAY, compared the safety, tolerability and immunogenicity of V114 to PCV13 (Prevnar® 13). The PNEU-PATH study included 652 healthy adults aged 50 years or older who received V114 or PCV13 followed by Pneumovax® 23 one year later. The PNEU-DAY study included 1514 adults aged 18 to 49 years at increased risk of pneumococcal disease who received V114 or PCV13 followed by Pneumovax 23 six months later.

Results from the PNEU-PATH study demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in V114. Additionally, findings from both studies showed that V114 generated immune responses comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F (the 2 serotypes not included in PCV13) at 30 days post-vaccination, based on opsonophagocytic activity responses. As for safety, V114 was found to be generally well tolerated in both studies with a safety profile consistent with that seen in previous trials.

Full study findings from the V114 clinical program will be presented at a future scientific congress. The program consists of 16 trials assessing V114 in a variety of populations including adults and children. According to Merck, regulatory licensure applications are expected to be submitted before the end of the year.

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These data provide important information about the potential for V114 followed by Pneumovax 23, a polysaccharide vaccine included in more than 90 percent of age-based adult pneumococcal immunization programs globally, to help protect healthy adults and adults who are at increased risk for pneumococcal disease.”

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The FDA previously granted Breakthrough Therapy designation to V114 for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.

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Merck announces positive topline results from two additional phase 3 adult studies evaluating v114, Merck’s investigational 15-valent pneumococcal conjugate vaccine. [press release]. Kenilworth, NJ: Merck; October 20, 2020.