Merck (NYSE: MRK), also known as MSD outside of the United States and Canada, has revealed findings from its Phase 3 trial, STRIDE-10, assessing V116, the company’s advanced 21-valent pneumococcal conjugate vaccine designed for adults. The announcement took place at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) conference in Barcelona, Spain. The trial investigated V116’s immunogenicity, tolerability, and safety in comparison to PPSV23 (23-valent pneumococcal vaccine) among adults aged 50 and above who hadn’t received a pneumococcal vaccine before.
Key outcomes from the study include:
- V116 demonstrated noninferior immune responses to PPSV23 for the 12 shared serotypes, as indicated by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30.
- Immune responses generated by V116 were superior for the nine serotypes unique to V116 and not present in PPSV23, as measured by OPA GMT ratios at Day 30. Moreover, for eight of the nine unique V116 serotypes compared to PPSV23, there was a superior proportion of participants exhibiting a ≥4-fold increase in immune responses.
- V116 exhibited a safety profile similar to that of PPSV23.
These results complement previous Phase 3 trial findings presented at the Meeting of the International Society of Pneumonia and Pneumococcal Diseases and the 2023 World Vaccine Congress West Coast.
Dr. Walter Orenstein, a professor emeritus at Emory University and a member of Merck’s Scientific Advisory Committee, emphasized the significance of these positive results in addressing invasive pneumococcal disease among adults.
Dr. Eliav Barr, Merck’s Senior Vice President, Head of Global Clinical Development, and Chief Medical Officer, highlighted the potential of V116 in filling existing gaps in serotype coverage for invasive pneumococcal disease.
In addition to clinical data, Merck presented findings suggesting that V116 could alleviate the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia in several European countries.
V116 is presently undergoing review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a target action date set for June 17, 2024. The vaccine aims to safeguard adults from invasive pneumococcal disease, targeting serotypes responsible for the majority of cases in individuals aged 65 and older.
The article also provides a summary of findings from the ESCMID conference, including data from the STRIDE-10 trial and studies on the health and economic impact of V116 in France, Sweden, Spain, and the Netherlands. These studies indicate that V116 may significantly reduce the burden associated with pneumococcal diseases in these countries compared to existing vaccines.
