An investigational 15-valent pneumococcal conjugate vaccine (V114) has proven safe and met immunogenicity objectives in a pair of clinical trials, according to a press release from the manufacturer. 

The PNEU-WAY (V114-018) phase 3 study included adults over the age of 18 with HIV, showing that the vaccine “elicited an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F,” the release said. The results from the PNEU-FLU (V114-02) trial included adults over the age of 50, with results showing that the vaccine can be given with the quadrivalent influenza vaccine. The results of the trial were published via the International Symposium on Pneumococci and Pneumococcal Diseases.

“Certain populations are at greater risk for pneumococcal disease, reinforcing the importance of investigating new interventions focused on their specific needs,” said Dr. Luwy Musey, executive director in biologics, vaccine clinical research, Merck Research Laboratories in the release. “Results from these first two phase 3 studies of V114 are encouraging and we look forward to sharing additional data in the future from our ongoing clinical development program, including our pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.” 

The PNEU-WAY trial included 302 patients who were randomized to receive either V114 or the currently available vaccine over the course of eight weeks, followed by PNEUMOVAX 23. The experimental vaccine met its primary immunogenicity objectives for all 15 serotypes 30 days after vaccination. Opsonophagocytic activity, geometric mean titers, and immunoglobulin G geometric mean concentrations for the 13 shared serotypes between the new and existing vaccines were “generally comparable,” according to the release. In comparison, immune responses were higher in the V114 group for the two unique serotypes. The safety was also comparable between the two options. 

The phase 3 PNEU-FLU trial included 1,200 patients. Those enrolled received V114 and the quadrivalent vaccine on day one and placebo 30 days later. Those in the non-concomitant group received placebo and QIV on day one and V114 approximately 30 days later. The study met both of its immunogenicity objectives, with 114 and QIV concomitantly proving noninferior compared to V114 given non-concomitantly with QIV at 30 days after vaccination with V114. QIV given concomitantly with V114 was noninferior to QIV GMTs at 30 days after vaccination with QIV. The safety was also comparable in both groups in this trial.