Preliminary Evaluation of the Safety and Immunogenicity of a Novel Protein-Based Pneumococcal Vaccine in Healthy Adults Aged 18–49: A Phase Ia Randomized, Double Blind, Placebo-Controlled Clinical Study

作者：Yanxia Wang, Gang Shi, Xue Wang, Zhiqiang Xie, Jin-Bo Gou, Lili Huang, Haitao Huang, Wangyang You, Ruijie Wang, Yongli Yang, Feiyu Wang, Tao Zhu, Dongyang Zhao · 发表于：Vaccines · 年份：2024 · DOI：10.3390/vaccines12080827 · 被引用次数：7 · 研究领域：Pneumonia and Respiratory Infections、Respiratory viral infections research、Pneumocystis jirovecii pneumonia detection and treatment

Background: Protein-based pneumococcal vaccines (PBPVs) may offer expanded protection against Streptococcus pneumoniae and tackle the antimicrobial resistance crisis in pneumococcal infections. This study examined the safety and immunogenicity in healthy adults vaccinated with three doses of a protein-based pneumococcal vaccine containing pneumococcal surface protein A (PspA) (PRX1, P3296 and P5668) and in combination with a recombinant detoxified pneumolysin protein (PlyLD). Methods: This phase Ia randomized, double blind, placebo-controlled clinical study enrolled healthy adults aged 18–49 years. The participants were randomized into experimental (low-dose, medium-dose, high-dose) and placebo groups in a ratio of 3:1. Three doses of investigational vaccine were given to the participants with an interval of two months. Safety endpoints included the occurrence of total adverse reactions, solicited local and systemic adverse reactions, unsolicited adverse reactions, serious adverse events (SAEs), and several laboratory parameters. Immunogenicity endpoints included geometric mean titers (GMT) of anti-PspA (PRX1, P3296 and P5668) and anti-PlyLD antibodies level as determined by ELISA, seropositivity rates of PspA and PlyLD antibodies (>4-fold increase) and neutralization activity of anti-Ply antibody in serum. Results: A total of 118 participants completed the study of three doses. The candidate PBPV was safe and well-tolerated in all experimental groups. No vaccine-related S...