One of Merck’s next-generation pneumococcal vaccines has sailed through a mid-stage trial and is being readied for a phase 3 study next month.
V116—one of three pneumococcal vaccines in Merck’s clinical pipeline—targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by any licensed vaccines.
The randomized, double-blind phase 1 study assessed safety, tolerability and immunogenicity of a single dose of V116 in comparison to Merck’s Pneumovax 23 in pneumococcal vaccine-naïve adults aged 18-49 years of age, while a phase 2 component looked at over-50s. In both populations, the shot met the primary immunogenicity objectives, with V116 shown to confer similar immunity to Pneumovax 23 for the serotypes common to both vaccines and higher than Pneumovax 23 for the serotypes unique to V116.
Data from the phase 1 part of the trial informed the FDA’s decision to grant the shot breakthrough designation in April.
In both parts of the trial, V116 was well tolerated with an overall safety profile generally comparable to Pneumovax 23. The results clear the path for a planned phase 3 trial in July, which will cover vaccine-naive and vaccine-experienced adults, according to Merck.
“Consistent with our portfolio strategy, V116 is designed to specifically target serotypes that are responsible for 85 percent of all invasive pneumococcal disease in individuals aged 65 and over in the U.S. as of 2019,” said Eliav Barr, M.D., head of global clinical development and chief medical officer at Merck Research Laboratories. “Importantly, the eight serotypes in V116 that are not included in any currently-licensed pneumococcal vaccine account for over 30% of this disease burden alone.”
Another of Merck’s pneumococcal vaccines, V114, has performed well when put into head-to-head matchups with Pfizer’s blockbuster shot Prevnar 13. Merck hopes that a third, V117, could become a key player in the company’s effort to compete with Pfizer in the pediatric market for pneumococcal vaccines.