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  

Post-marketing immunogenicity and safety of domestic 23-valent pneumococcal polysaccharide vaccine:a multicenter study

作　　者：张岷 张锐智[2] 叶新贵[2] 赵俊仕[3] 张冬娟[4] 兰芳[5] 严龙[5] 朱海燕 肖莉[7] 汤章彬[8] 陈娟[5] 王俊峰 陈海平 杨渊 王圣怡 石煊雯 刘小琴 刘少祥 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(Medical Affairs Department,China National Biotec Group Company Limited,Beijing 100024,China;Institute of Immunization Planning,Guizhou Provincial Center for Disease Control and Prevention,Guiyang 550004,China;Vaccine Clinical Research Center,Hunan Provincial Center for Disease Control and Prevention,Changsha 410005,China;Institute of Immunization Planning,Fujian Provincial Center for Disease Control and Prevention,Fuzhou 350001,China;Vaccine Engineering Research Center of Sichuan Province,Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China;Center for Disease Control and Prevention of Qingzhen City,Guiyang 551499,China;Center for Disease Control and Prevention of Qidong County,Hengyang 421699,China;Center for Disease Control and Prevention of Nan′an City,Quanzhou 362399,China)

机构地区：[1]中国生物技术股份有限公司医学事务部,北京100024 [2]贵州省疾病预防控制中心免疫规划所,贵阳550004 [3]湖南省疾病预防控制中心疫苗临床研究中心,长沙410005 [4]福建省疾病预防控制中心免疫规划所,福州350001 [5]成都生物制品研究所有限责任公司,四川省疫苗工程技术研究中心,成都610023 [6]清镇市疾病预防控制中心,贵阳551499 [7]祁东县疾病预防控制中心,衡阳421699 [8]南安市疾病预防控制中心,泉州362399

出　　处：《中华微生物学和免疫学杂志》2022年第11期865-870,共6页Chinese Journal of Microbiology and Immunology

摘　　要：目的评价23价肺炎球菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine,PPV23)上市后的安全性和免疫原性。方法2020年9月—2021年6月,在贵州省、湖南省和福建省疾病预防控制中心对≥3岁的人群开展接种1剂PPV23的临床试验。接种前和接种后30 d,采集受试者静脉血5.0 ml,分离血清,ELISA定量检测人血清中23种抗特定血清型肺炎链球菌荚膜多糖IgG抗体,进行肺炎球菌疫苗抗体水平、2倍增长率比较。主动监测接种后0~7 d的不良事件。结果409人完成入组及接种,纳入安全性分析,其中1人抗体水平倒置,408人纳入免疫原性分析。23种血清型抗体的2倍增长率为51.72%~96.81%。疫苗免疫后,23种血清型抗体水平均有提高。总抗体2倍增长率为78.59%,抗体平均增长倍数为4.24。研究期间不良事件的总发生率为27.14%(111/409),局部不良事件以疼痛、硬结、红、肿胀为主,严重程度主要以1级为主,未发生与疫苗相关的严重不良事件。结论本研究初步证明,PPV23疫苗接种后有良好的免疫原性和安全性。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.

关 键 词：23价肺炎球菌多糖疫苗 安全性 免疫原性 多中心 

分 类 号：R392[医药卫生—免疫学]