Positive data for V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed for adults

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.

Key results from the study include: i. V116 elicited immune responses that were non-inferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. ii. Immune responses elicited by V116 were superior for the nine serotypes included in V116 but not PPSV 23, as measured by OPA GMT ratios at Day 30, and superior for eight of nine serotypes unique to V 116 compared to PPSV 23, as measured by the proportions of participants with ?4-fold rise in immune responses. iii. V 116 had a safety profile comparable to PPSV23.

These data build upon Phase III trial results that were presented at this year’s Meeting of the International Society of Pneumonia and Pneumococcal Diseases and the 2023 World Vaccine Congress West Coast.

“Invasive pneumococcal disease and pneumococcal pneumonia represent significant public health challenges, particularly among older adult populations and those with risk conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.”

“Even with the availability of current pneumococcal conjugate vaccines for adults, gaps in serotype coverage for invasive pneumococcal disease persist,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These data add 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.”

In addition to the clinical data on V116, Merck also presented findings that suggest V116 may help to reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in France, Sweden, Spain, and the Netherlands.

V116 is currently under review by the FDA and the European Medicines Agency (EMA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.

Summary of Findings from Select Studies Presented at ESCMID; 1. Data from STRIDE-10 (Abstract #353); STRIDE-10 (NCT05569954) is a Phase III, randomized, double-blind, active comparator-controlled study evaluating the immunogenicity, tolerability and safety of V116 compared to PPSV23 in adults 50 years of age and older who had not previously received pneumococcal vaccine (n=1,484). Participants were randomized to receive a single dose of either V116 or PPSV23. The primary objectives included serotype-specific OPA GMTs 30 days post-vaccination and percentage of participants with greater than or equal to four-fold rise from baseline in serotype-specific OPAs. Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs).

Results demonstrated that: i. V116 elicited noninferior immune responses for the 12 serotypes (or strains) shared with PPSV23 (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F), as measured by serotype-specific OPA GMTs 30 days post-vaccination; ii. V116 elicited superior immune responses for the nine serotypes only covered by V116 and not PPSV23 (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMT ratios 30 days post-vaccination; iii. The proportion of patients with greater than 4-fold rise in OPA GMT ratios from Day 1 to Day 30 for serotype-specific OPA for V116 was superior to PPSV23 for eight out of nine serotypes unique to V116 compared to PPSV23; iv. V116 had a comparable safety profile to PPSV23.

Data from Health and Economic Burden of Disease Studies (Abstract #7201, Abstract #2784, Abstract #2738, and Abstract #2843): Four studies were conducted to quantify the health and economic burden of invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia attributable to V116 and PCV20 (pneumococcal 20-valent conjugate vaccine) serotypes among adults in France, Sweden, Spain, and the Netherlands. Across the studies, results showed that when compared with PCV20, V116 serotypes were associated with considerably higher health and economic burden in France, Sweden, Spain, and the Netherlands––the difference is driven largely by the eight unique V116 serotypes not in any currently approved pneumococcal vaccine, suggesting V116 may help reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in these countries.