Journal Article

A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naïve Japanese adults ≥65 years of age

Igarashi, Rie, Sawata, Miyuki, Inoue, Satoshi, Platt, Heather L., Oshima, Nobuyuki, Matsuoka, Osamu, Yagi, Michio, Kishino, Hiroyuki

2025

Overview

Pneumococcal disease (PD) prevention remains an unmet medical need in older adults. V116 is an adult-specific, 21-valent pneumococcal conjugate vaccine (PCV) specifically designed to provide protection against pneumococcal serotypes associated with a large proportion of residual invasive pneumococcal disease (IPD). This phase 3 study evaluated the safety, tolerability, and immunogenicity of V116 compared with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese older adults (NCT05633992). In this phase 3, randomized, double-blind, active comparator-controlled study, 450 vaccine-naïve adults ≥65 years of age were randomized 1:1 to receive a single dose of V116 or PPSV23. Primary immunogenicity objectives were to assess opsonophagocytic activity (OPA) and demonstrate: i) non-inferiority for V116 versus PPSV23 across 12 common serotypes, and cross-reactive serotype 15B in V116, based on geometric mean titers (GMTs) at Day 30; and ii) superiority for nine serotypes unique to V116 based on the proportions of participants exhibiting ≥4 fold rises in serotype-specific OPA responses between baseline and Day 30 (excluding serotype 15C) or based on GMTs at Day 30 (serotype 15C only). The primary safety outcome measured the proportion of participants with adverse events (AEs). V116 was non-inferior compared with PPSV23 for the 12 common serotypes and for the cross-reactive serotype 15B. V116 was superior compared with PPSV23 for the nine unique serotypes (including serotype 15C). The proportion of participants with AEs was comparable between V116 and PPSV23, and there were no vaccine-related serious AEs or deaths. In vaccine-naïve Japanese adults ≥65 years of age, V116 is well tolerated, with a safety profile comparable to PPSV23, and elicits immune responses to all V116 serotypes and the cross-reactive serotype 15B. V116 has the potential to broaden protection against PD in Japan through the inclusion of serotypes responsible for the majority of residual PD in adults. •IPD burden is highest in adults ≥65 years of age; this group accounts for 29 % of Japan's population.•Residual PD remains an unmet medical need, partly caused by non-vaccine-type serotypes.•Serotypes in V116 are responsible for ∼80 % of residual IPD in individuals ≥15 years of age in Japan.•V116 has the potential to broaden protection against residual PD in adults.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adult / Adults / Age / Age groups / Aged / Aged, 80 and over / Allergy and Immunology / Antibodies / Antibodies, Bacterial - blood / Antigens / Conjugates / Coronaviruses / COVID-19 / Double-Blind Method / Evaluation / Female / Humans / Immune response / Immunization / Immunogenicity / Immunogenicity, Vaccine / Invasive pneumococcal disease / Japan / Male / Older people / Opsonophagocytic activity / Pediatrics / Pneumococcal conjugate vaccine / Pneumococcal Infections - immunology / Pneumococcal Infections - prevention & control / Pneumococcal Vaccines - administration & dosage / Pneumococcal Vaccines - adverse effects / Pneumococcal Vaccines - immunology / Polysaccharides / Review boards / Safety / Serogroup / Serotype / Serotypes / Streptococcus infections / Streptococcus pneumoniae / Streptococcus pneumoniae - immunology / Vaccines / Vaccines, Conjugate - administration & dosage / Vaccines, Conjugate - adverse effects / Vaccines, Conjugate - immunology