US-based pharmaceutical company Merck & Co (MSD) has reported positive topline data from two Phase III clinical trials of its investigational 21-valent pneumococcal conjugate vaccine, V116, in vaccine-naïve and earlier inoculated people.
Named STRIDE-3 and STRIDE-6, the randomised, double-blind trials assessed the vaccine's tolerability, safety and immunogenicity against another pneumococcal 20-valent conjugate vaccine, PCV20, in adult patients who are naïve to pneumococcal vaccine.
Patients in the trial were given either a single dose of V116 or PCV20.
The trial's primary endpoints were serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 30 days after vaccination, as well as the safety and percentage of subjects having a nearly fourfold or more increase in serotype-specific OPAs from baseline.
According to data from the STRIDE-3 trial, V116 provided 'statistically significant' immune responses compared with PCV20.
The STRIDE-6 trial data showed that V116 was immunogenic for all 21 pneumococcal serotypes comprised in the vaccine in adult subjects who had been inoculated with a pneumococcal vaccine a minimum of one year before entering the trial.
V116 also showed a safety profile in line with the comparator in both trials.
MSD Research Laboratories senior vice-president, global clinical development head and chief medical officer Dr Eliav Barr said: “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older.
“These results support the potential for V116 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.”
MSD and Moderna recently began a Phase III trial of investigational individualised neoantigen therapy, V940, in combination with Keytruda for resected high-risk (Stage IIB-IV) melanoma.
The randomised, double-blind trial aims to evaluate the combination therapy's safety and efficacy against those of Keytruda alone in patients with resected high-risk melanoma.
