An investigational pneumococcal conjugate vaccine (PCV) candidate, developed by MSD, has achieved positive topline results in a Phase III paediatric study.
The vaccine candidate – V114 – is an investigational 15-valent PCV, consisting of pneumococcal polysaccharides from 15 serotypes, conjugated to a CRM197 carrier protein.
This includes serotypes 22F and 33F, commonly associated with invasive pneumococcal disease and are not contained in the pneumococcal conjugate currently licensed for use in children and adults.
Results from two trials of V114 in MSD’s Phase III paediatric clinical programme found that the investigational candidate met its primary immunogenicity and safety endpoints.
In the PNEU-DIRECTION interchangeability study in healthy infants, immune responses in children who received a four-dose series of PCV13 (the currently available 13-valent pneumococcal conjugate vaccine) and those who received a mixed dose schedule of PCV13 followed by V114 were generally comparable for the 13 serotypes covered by both jabs.
In the second study, PNEU-PLAN, immune responses were generally comparable to PCV13 for the 13 shared serotypes when V114 was used as a catch-up regimen in children aged seven months to 17 years of age who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a licensed paediatric PCV.
In addition, for serotypes 22F and 33F, the two serotypes included in V114 that are not in PCV13, immunogenicity in this study was higher in the V114 group compared to the PCV13 group.
“Results from these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants who have previously received one or multiple doses of PCV13, and for the 15 serotypes in V114 in children in a catch-up setting,” Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
