A randomized, blind, parallel controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and older

• Published in: Vaccine Vol. 42; no. 11; pp. 2858 - 2866
• Main Authors: Zhang, Yuhui, Wang, Yanxia, Li, Guangfu, Zhao, Xue, Wang, Kai, Jia, Chunyu, Yang, Yongli, Huang, Lili, Tan, Jiebing, Chen, Xiaofen, Leng, Wenna, Xie, Zhiqiang, Zhang, Wei, Zong, Juan, Chen, Kang, Li, Qin, Jia, Xiaocan, Zhao, Dongyang, An, Youcai, Zhang, Yaodong
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 19.04.2024; Elsevier Limited
• Subjects: 23-valent pneumococcal polysaccharide vaccine; Adverse events; Age; Allergy and Immunology; antibodies; Antibodies, Bacterial; Biochemistry; Biotechnology; Blood; blood serum; China; Clinical trial; Clinical trials; Disease control; Disease prevention; Enzyme-linked immunosorbent assay; enzymes; Erythema; Guillain-Barre syndrome; Health care; Humans; IgG antibody; Immunization; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulin G; Injection; injection site; intramuscular injection; Mortality; Older people; pain; people; Pneumococcal Infections - prevention & control; Pneumococcal Vaccines; Pneumonia; Polysaccharides; Public health; Safety; Seroconversion; Serotypes; Side effects; Streptococcus infections; Streptococcus pneumoniae; Vaccination; Vaccines; Vaccines, Conjugate; China; Henan China; Clinical trial; Safety; Immunogenicity; Streptococcus pneumoniae; 23-valent pneumococcal polysaccharide vaccine
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.03.044

Despite some progress in pneumococcal immunization, the global burden of pneumococcal infection remains high, and pneumococcal disease remains a public health concern. Studies in China and abroad have found that 23-valent pneumococcal polysaccharide vaccine (PPV23) vaccination can effectively prevent invasive pneumococcal disease. This phase Ⅰ clinical study assessed the safety and immunogenicity of a PPV23 vaccine candidate. All subjects were randomly assigned to receive one dose intramuscular injection of experimental vaccine or control vaccine at a ratio of 1:1. The incidence of any adverse events was observed within 30 min, 0–7 days and 8–28 days post vaccination and the incidence of abnormal blood biochemical and blood routine indicators were tested on the 4th day post vaccination, the incidence of serious adverse events (SAEs) at 6 months post vaccination was recorded. Blood samples were collected prior to vaccination and on the 28th day post vaccination, and serum antibodies were detected by enzyme linked immunosorbent assay (ELISA). The most common adverse reaction was pain at the injection site, followed by erythema. There was no significant difference of the incidence of systemic adverse reactions between the two vaccine groups. The adverse reactions observed in the trial were all common vaccination-related reactions, and no serious adverse reactions were observed. Compared to pre-vaccination, the (geometric mean concentrations) GMCs of IgG (immunoglobulin G) specific antibody against each serotype were all increased in the experimental group and the control group, there were statistical differences in seroconversion rates of serotypes 4 and 20 between the two vaccine groups. This clinical study showed good safety of the PPV23 vaccine candidate produced by Ab&b Biotechnology Co., Ltd.JS had good safety after vaccination in people aged 2 years and older. At the same time, good immunogenicity was also demonstrated.