Authors
Kangning Wang, Jialei Hu, Huagen Chen, Zhu Wang, Xianchao Zhu, Hongxing Pan
Published in
Expert review of vaccines. Volume 25. Issue 1. Pages 2746803. Epub Oct 22, 2026.
Abstract
Conventional pneumococcal vaccines cover limited serotypes. This study evaluated the safety and immunogenicity of 24-valent pneumococcal conjugate vaccine (PCV24) in Chinese adults aged ≥18 years.
Two single-center, randomized, double-blind Phase 1/2 trials were conducted. Two hundred forty Phase 1 participants were randomized with an overall allocation ratio of 1:1:1:1 to low/high dose PCV24, 23-valent pneumococcal polysaccharide vaccine (PPSV23), or placebo. Nine hundred ninety‑two Phase 2 participants were randomized (1:1:1:1) to receive one of three PCV24 formulations (low-dose and low adjuvant, low-dose, high-dose) or PPSV23. Adverse events (AEs) within 30 days post-vaccination and study-wide serious adverse events (SAEs) were collected. Blood samples were tested for immunogenicity in Phase 2.
Post-vaccination adverse reactions (ARs) within 0-30 days were primarily grade 1-2, with rare grade 3 events limited to the 0-7 days. No vaccine-related SAEs occurred over 6 months. Immunogenicity analysis confirmed that in all participants aged ≥18 years, the PCV24 high-dose group met non-inferiority criteria for IgG seroconversion of all 24 serotypes compared with PPSV23.
The PCV24 vaccine exhibits a favorable safety profile and robust immunogenicity in Chinese adults aged ≥18 years, supporting further efficacy studies in larger populations.
www.clinicaltrials.gov identifier: NCT07025876; NCT07035054.
PMID:
42908339
Bibliographic data and abstract were imported from PubMed on 23 Oct 2026.
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