A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE)

• DOI: 10.1016/j.vaccine.2021.08.049
• Publication Date: 2021-09-08T08:40:54Z
• Authors: Heather L. Platt; Jose F. Cardona; Miwa Haranaka; Howard I. Schwartz; Silvia Narejos Perez; Anthony Dowell; Chih-Jen Chang; Ron Dagan; Gretchen M. Tamms; Tina Sterling; Leslie Morgan; Yaru Shi; Alison Pedley; Luwy K. Musey; Ulrike K. Buchwald
• Keywords: Pneumococcal Conjugate Vaccine; Tolerability

Pneumococcal conjugate vaccines (PCVs) have greatly reduced the incidence of pneumococcal disease, yet unmet medical need remains due to increased disease caused by non-vaccine serotypes (STs). V114 (VAXNEUVANCETM, Merck Sharp & Dohme Corp., a subsidiary Co., Inc., Kenilworth, NJ, USA) is 15-valent PCV containing 13 in licensed PCV13 and 2 additional (22F, 33F) which significantly contribute burden. This phase 3 trial compared safety, tolerability, immunogenicity adults ≥50 years age. Adults were randomized 1:1 receive single dose or PCV13; randomization was stratified age (50–64 years, 65–74 ≥75 years). Adverse events (AEs) collected following vaccination. Serotype-specific opsonophagocytic activity (OPA) immunoglobulin G (IgG) antibodies measured prior 30 days after vaccination (Day 30). Primary objectives included assessing noninferiority for shared superiority two unique serotypes. Superiority serotype assessed as secondary objective. Overall, 1,202 participants vaccinated (V114 N = 602, 600). The most commonly reported AEs across both groups injection-site pain, fatigue, myalgia. met criteria (using 2-fold non-inferiority margin ratio OPA geometric mean titers [GMTs] [V114/PCV13] at Day 30) super-superiority GMTs 0.10 difference proportions with ≥4-fold rise from prevaccination (based on 1.2 0 rise). [NCT03950622, EudraCT#2018-004316-22, Japic-CTI#194845].