Post-marketing immunogenicity and safety of domestic 23-valent pneumococcal polysaccharide vaccine: a multicenter study
10.3760/cma.j.cn112309-20220518-00166
- VernacularTitle:国产23价肺炎球菌多糖疫苗上市后免疫原性和安全性多中心临床观察
- Author:
Min ZHANG
1
;
Ruizhi ZHANG
;
Xingui YE
;
Junshi ZHAO
;
Dongjuan ZHANG
;
Fang LAN
;
Long YAN
;
Haiyan ZHU
;
Li XIAO
;
Zhangbin TANG
;
Juan CHEN
;
Junfeng WANG
;
Haiping CHEN
;
Yuan YANG
;
Shengyi WANG
;
Xuanwen SHI
;
Xiaoqin LIU
;
Shaoxiang LIU
Author Information
1. 中国生物技术股份有限公司医学事务部，北京 100024
- Keywords:
23-valent pneumococcal polysaccharide vaccine;
Safety;
Immunogenicity;
Multicenter
- From:
Chinese Journal of Microbiology and Immunology
2022;42(11):865-870
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the post-marketing safety and immunogenicity of a 23-valent pneumococcal polysaccharide vaccine (PPV23).Methods:From September 2020 to June 2021, a clinical trial of single-dose PPV23 was conducted in people ≥3 years old in Centers for Disease Control and Prevention of Guizhou, Hunan and Fujian provinces. Blood samples were collects from the subjects before and 30 d after vaccination. ELISA was used to quantitatively detect IgG antibodies against capsular polysaccharides of 23 Streptococcus pneumoniae serotypes in serum samples. The adverse events (AEs) were monitored within 7 d after vaccination. Results:A total of 409 subjects were enrolled and included in safety analysis. Except for one with antibody level inversion, the other 408 participants were included in immunogenicity analysis. The levels of antibodies against the 23 Streptococcus pneumoniae serotypes were all increased after vaccination by an average of 4.24 folds. The two-fold growth rates of the antibodies ranged from 51.72% to 96.81% with a total two-fold growth rate of 78.59%. The overall rate of AEs was 27.14% (111/409). Local AEs were mainly pain, induration, redness and swollen. No serious adverse events related to vaccination occurred. Conclusions:This study preliminarily demonstrated the good immunogenicity and safety of PPV23 vaccine.
