Positive data on V 116, an investigational, 21-Valent pneumococcal conjugate vaccine specifically designed for adults, demonstrated immune responses in adults

Across the clinical studies presented, V 116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV). V 116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

“Invasive pneumococcal disease and pneumococcal pneumonia can cause serious illness, especially in older adults and those with immunocompromising 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 data demonstrate the potential for V 116 to address an unmet need in adult pneumococcal disease prevention.”

Key findings from the studies include: i. In pneumococcal vaccine-naïve adults 50 years of age and older (STRIDE-3 sub-group), V 116 was immunogenic for all 21 serotypes across the studied age groups (50–64, 65–74 and 75–84 years), as assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30; ii. In pneumococcal vaccine-experienced adults 50 years of age and older (STRIDE-6), V 116 elicited comparable immune responses for the serotypes shared with PCV15 (pneumococcal 15-valent conjugate vaccine) or PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) and higher immune responses for the serotypes covered by V 116 only, regardless of the previous pneumococcal vaccine received or time since prior pneumococcal vaccination, as assessed by serotype-specific OPA GMTs at Day 30; iii. In adults 18 years of age and older living with HIV (STRIDE-7), V 116 elicited comparable immune responses to PCV15+PPSV23 for all 13 shared serotypes and higher immune responses for the eight serotypes covered by V 116 only, as assessed by serotype-specific OPA GMTs and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at Day 30; iv. Across all presented studies, V 116 demonstrated a safety profile comparable to the studied comparators, including PCV20 (pneumococcal 20-valent conjugate vaccine), PCV15 and PPSV23.

In addition to Phase III clinical data on V 116 , Merck also presented preliminary data from the real-world evidence study in the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO), which found that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected. Of these serotypes, approximately 84% were covered by V 116. One fourth (approximately 25%) of the detected serotypes were covered only by V 116 and not by PCV15 or PCV20.

Results from the PNEUMO study support that the serotypes in V 116 account for the majority of pneumococcal disease (including invasive and non-invasive) in adults 50 years of age and older. These data are consistent with CDC surveillance data for invasive pneumococcal disease from 2018-2021, which show that V 116 covers serotypes responsible for approximately 83% of invasive pneumococcal disease, including the eight serotypes unique to V 116 which are responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older.

Several of the studies presented at ISPPD were included in the filing submission to the FDA. The FDA granted V 116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. If approved, V 116 would be the first pneumococcal conjugate vaccine specifically designed for adults.