Merck (MSD) has reported data from the Phase III STRIDE-3 clinical trial of its investigational 21-valent pneumococcal conjugate vaccine, V116, for usage in the adult population.
The double-blind, randomised, active, comparator-controlled trial is designed to analyse the tolerability, safety, and immunogenicity of V116 versus PCV20, a pneumococcal 20-valent conjugate vaccine.
It enrolled adult subjects aged 18 years and above who had not previously received any pneumococcal conjugate vaccines.
According to the trial findings, V116 offered non-inferior immune responses in adults aged 50 years and above (Cohort 1), versus PCV20 for all ten serotypes shared by both vaccines.
At day 30, the vaccine induced superior immune responses for ten out of 11 serotypes that were part of V116, but not PCV20.
The proportions of trial subjects in the V116 arm experienced more than or equal to a four-fold rise in opsonophagocytic activity (OPA) from day one to day 30.
The vaccine also induced non-inferior immune responses in adults aged 18 to 49 years (Cohort 2), versus subjects in Cohort 1, 30 days after inoculation.
V116 demonstrated a safety profile in line with PCV20 for both trial cohorts.
The Centers for Disease Control and Prevention (CDC) data from 2018-2021 shows that the 21 serotypes included in V116 are responsible for nearly 83% of invasive pneumococcal disease in individuals aged 65 years and above.
Merck Research Laboratories global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr said: “These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.
“We are excited by the potential of V116 to impact public health through primary prevention through the use of a population-specific strategy that targets the serotypes responsible for the majority of invasive pneumococcal disease in adults.”
In July 2023, the company reported positive topline findings from two Phase III trials of V116 in vaccine-naïve and earlier inoculated individuals.
