Merck & Co – known as MSD outside the US and Canada – has announced positive results from a late-stage study of its investigational, adult-specific 21-valent pneumococcal conjugate vaccine.
Diseases caused by Streptococcus pneumoniae bacteria are considered a “major public health problem worldwide” by the World Health Organization.
There are more than 100 types of pneumococcal bacteria, which can affect adults differently than children. Certain strains threaten to put more people at risk for invasive pneumococcal illnesses, with older adults and those with chronic or immunocompromising health conditions among those most vulnerable to serious infection.
Merck’s V116 is specifically designed to address the strains of Streptococcus pneumoniae that are responsible for the majority of adult pneumococcal disease, including eight strains that account for approximately 30% of adult disease but are not included in any currently approved pneumococcal vaccine.
The phase 3 STRIDE-10 trial has been comparing V116 against PPSV23 in adults aged 50 years and older who had not previously received a pneumococcal vaccine.
According to results from the study presented at this year’s European Society of Clinical Microbiology and Infectious Diseases, V116 elicited immune responses that were noninferior to PPSV23 for the 12 strains common to both vaccines, as measured by serotype-specific opsonophagocytic activity geometric mean titres at day 30.
Merck’s vaccine also induced superior immune responses for its nine unique strains on the same measure, and superior immune responses for eight of these, as measured by the proportions of participants with at least a four-fold rise in immune responses.
Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said: “Even with the availability of current pneumococcal conjugate vaccines for adults, gaps in serotype coverage for invasive pneumococcal disease persist.
“This data adds to the evidence supporting the potential for V116 to become an important new preventative option for adults, with results showing V116 elicited immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.”
The readout comes just over a month after Merck presented positive results from multiple phase 3 trials of V116 at this year’s Meeting of the International Society of Pneumonia and Pneumococcal Diseases, with the data showing that the candidate generated immune responses for all 21 serotypes covered by the vaccine in a variety of adult populations.