V 116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed for adults, met key immunogenicity and safety endpoints in two phase III trials

If approved, V 116 would be the first pneumococcal conjugate vaccine specifically designed for adults.

Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V 116. Additionally, results from STRIDE-6 demonstrated that V 116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study. In both studies, V 116 had a safety profile comparable to the comparator in the studies. Results will be shared with the scientific community in the near future and will support global regulatory licensure applications.

According to pre-pandemic 2019 CDC data, the 21 serotypes covered by V 116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older. V 116 includes eight serotypes not currently covered by approved pneumococcal vaccines. Serotypes unique to V 116 include 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older, based on pre-pandemic 2019 CDC data.

“Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These results support the potential for V 116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status, by expanding coverage to include eight serotypes not currently included in any licensed vaccine. We are very grateful to the patients and investigators who contributed to these studies.”