摘要
目的评价3~7岁儿童同时接种23价肺炎球菌多糖疫苗(PPV23)和流感病毒裂解疫苗(TIV)的免疫原性和安全性.方法招募3~7岁健康儿童,随机分为3组,分别接种PPV23(PPV23组)、TIV(TIV组)以及同时接种PPV23和TIV(联合组),并随访1年.结果本研究共招募1035人,其中PPV23组327人,TIV组348人,联合组360人.联合组的7种肺炎球菌血清型几何平均浓度(GMC)与PPV23组相比差异均无统计学意义(P>0.05).联合组的3种流感病毒血清型与TIV组相比,联合组的甲3型血清阳转率较高(88.75%vs.84.20%,P=0.01),但乙型的血清阳转率较低(92.84%vs.98.56%,P<0.001).观察期内3组的一级不良反应差异无统计学意义(P=0.197);联合组的二级不良反应发生率为3.61%,高于其他两组(均P<0.001).所有不良反应均在对症治疗后痊愈,无三级及以上严重不良反应发生.结论联合组的PPV23和TIV均具有良好的免疫原性和安全性,可以同时接种,推荐作为预防易感儿童季节性流感和肺炎球菌感染的免疫策略.
Objective To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine(PPV23)and trivalent influenza vaccine(TIV)in pre-schoolers.Methods A total of 1035 children aged 3-7 years were enrolled in this study and randomly di-vided into three groups,inoculated PPV23,TIV and both,respectively.A one-year follow-up study was conducted for immunogenicity and safety analysis.Results A total of 1035 serological specimens were col-lected,including 327 in PPV23 group,348 in TIV group and 360 in concomitant vaccination group.No sig-nificant differences in geometric mean concentrations(GMC)of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group.Compared with the TIV group,the con-comitant vaccination group showed higher serological conversion rate of H3 type(88.75%vs 84.20%,P=0.01),but lower serological conversion rate of B type(92.84%vs 98.56%,P<0.001).There was no significant difference in the primary adverse reactions between the three groups(P=0.197).The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3.61%,which was higher than that of the other two groups(both P<0.001).All adverse reactions were mild or moderate,and cured after treatment.Conclusions Concomitant immunization with PPV23 and TIV is safe and have good immu-nogenicity,thus a viable immune strategy for susceptible children.
作者
汪志国
孙翔
张岷
汤奋扬
马福宝
许燕
胡冉
马燕丽
肖艳慧
陈海平
罗林云
Wang Zhiguo;Sun Xiang;Zhang Min;Tang Fenyang;Ma Fubao;Xu Yan;Hu Ran;Ma Yanli;Xiao Yanhui;Chen Haiping;Luo Linyun(Department of Expanded Programme on Immunization,Jiangsu Provincial Centre for Disease Control and Prevention,Nanjing 210009,China;Department of Medical Affairs,Chinese Biotechnology Company Limited,Beijing 100024,China)
出处
《中华微生物学和免疫学杂志》
CAS
CSCD
北大核心
2019年第10期758-762,共5页
Chinese Journal of Microbiology and Immunology
关键词
肺炎球菌多糖疫苗
流感病毒裂解疫苗
学龄前儿童
免疫原性
安全性
Pneumococcal polysaccharide vaccine(PPV23)
Trivalent influenza vaccine(TIV)
Preschoolers
Safety
Immunogenicity
作者简介
通信作者:陈海平,Email:chenhaiping@sinopharm.com,电话:010-84669389。
