Post-marketing immunogenicity and safety of domestic 23-valent pneumococcal polysaccharide vaccine: a multicenter study
Zhang Min, Zhang Ruizhi, Ye Xingui, Zhao Junshi, Zhang Dongjuan, Lan Fang, Yan Long, Zhu Haiyan, Xiao Li, Tang Zhangbin, Chen Juan, Wang Junfeng, Chen Haiping, Yang Yuan, Wang Shengyi, Shi Xuanwen, Liu Xiaoqin, Liu Shaoxiang
Abstract
ObjectiveTo evaluate the post-marketing safety and immunogenicity of a 23-valent pneumococcal polysaccharide vaccine (PPV23).
MethodsFrom 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.
ResultsA 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.
ConclusionsThis study preliminarily demonstrated the good immunogenicity and safety of PPV23 vaccine.
Key words:
23-valent pneumococcal polysaccharide vaccine; Safety; Immunogenicity; Multicenter
Contributor Information
Zhang Min
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Zhang Ruizhi
Institute of Immunization Planning, Guizhou Provincial Center for Disease Control and Prevention, Guiyang 550004, China
Ye Xingui
Institute of Immunization Planning, Guizhou Provincial Center for Disease Control and Prevention, Guiyang 550004, China
Zhao Junshi
Vaccine Clinical Research Center, Hunan Provincial Center for Disease Control and Prevention, Changsha 410005, China
Zhang Dongjuan
Institute of Immunization Planning, Fujian Provincial Center for Disease Control and Prevention, Fuzhou 350001, China
Lan Fang
Vaccine Engineering Research Center of Sichuan Province, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
Yan Long
Vaccine Engineering Research Center of Sichuan Province, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
Zhu Haiyan
Center for Disease Control and Prevention of Qingzhen City, Guiyang 551499, China
Xiao Li
Center for Disease Control and Prevention of Qidong County, Hengyang 421699, China
Tang Zhangbin
Center for Disease Control and Prevention of Nan′an City, Quanzhou 362399, China
Chen Juan
Vaccine Engineering Research Center of Sichuan Province, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
Wang Junfeng
Vaccine Engineering Research Center of Sichuan Province, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
Chen Haiping
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Yang Yuan
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Wang Shengyi
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Shi Xuanwen
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Liu Xiaoqin
Medical Affairs Department, China National Biotec Group Company Limited, Beijing 100024, China
Liu Shaoxiang
Vaccine Engineering Research Center of Sichuan Province, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
