摘要
目的评价3种肠道病毒71型(Enterovirus 71,EV-71)灭活疫苗的免疫原性和接种后不良反应。方法在嵊州市招募480名6~35月龄健康儿童作为研究对象,分别接种3个厂家生产的已上市EV-71灭活疫苗A、B、C。检测接种前和接种两剂次后28~35 d的血清EV-71中和抗体滴度,分析免疫后抗体阳转率和几何平均滴度(Geometric mean titer,GMT)。采用被动和主动监测的方法随访每剂次接种后出现的不良反应。结果在完成两剂次接种及中和抗体检测的451名儿童中,共有449人EV-71中和抗体阳转,阳转率为99.56%,抗体GMT为1∶114.45。A、B、C 3种疫苗的抗体阳转率和GMT差异无统计学意义(P>0.05)。不同月龄儿童接种A、C疫苗的抗体阳转率差异无统计学意义(P>0.05),而抗体GMT差异有统计学意义(P<0.05);不同月龄儿童接种B疫苗的抗体阳转率和GMT差异均有统计学意义(P<0.05)。3种疫苗中,不同性别儿童的抗体阳转率及GMT差异均无统计学意义(P>0.05)。在接种后30 min~3 d内,共有8例(0.85%)发生不良反应。共480人接种第一剂次,接种后6例(1.25%)发生不良反应;461人接种第二剂次,接种后2例(0.43%)发生不良反应,第一剂次和第二剂次接种后的不良反应发生率差异有统计学意义(P<0.05)。结论嵊州市6~35月龄儿童EV-71疫苗接种后有较好的免疫原性和较低的不良反应发生率,建议推广接种。
Objective To evaluate the immunogenicity and adverse reactions of Enterovirus 71(EV-71)inactivated vaccines.Methods 480 healthy children aged 6-35 months were recruited in Shengzhou and inoculated with three kinds of EV-71 inactivated vaccines A,B and C produced by 3 manufacturers.The serum anti-EV-71 neutralizing antibodies were detected before vaccination and 28-35 days after 2 doses vaccination,and the positive rate and geometric mean titer(GMT)of the antibodies were analyzed after immunization.The adverse reactions after each dose were followed up by passive and active monitoring.Results Among 451 children who completed 2 doses of inoculation and neutralizing antibody detection,449 of them had positive conversion of anti-EV-71 neutralizing antibody,positive conversion rate was 99.56%,antibody GMT was 1∶114.45.There was no significant difference in antibody positive rate and GMT of A,B and C vaccine(P>0.05).There was no significant difference in antibody positive conversion rate(P>0.05),but there was significant difference in antibody GMT(P<0.05)in different months children inoculated with A and C vaccines.The antibody positive rate and GMT of antibody inoculated with B vaccine in children of different months had statistical significance(P<0.05).In group A,B and C vaccine,there was no statistical significance in antibody positive conversion rate and GMT of children of different genders(P>0.05).Within 30 min to 3 days after inoculation,a total of 8 cases(0.85%)had adverse reactions.A total of 480 children received the first dose,6 children(1.25%)had adverse reactions after inoculation,a total of 461 children received the second dose,and 2 children(0.43%)had adverse reactions after inoculation.There was statistical significance in the incidence of adverse reactions after the first dose and the second dose(P<0.05).Conclusion EV-71 vaccine has good immunogenicity and low incidence of adverse reactions in children aged from 6 to 35 months in Shengzhou.
作者
邢博
王慎玉
胡晓松
陈颖萍
梁贞贞
吕华坤
XING Bo;WANG Shen-yu;HU Xiao-song;CHEN Ying-ping;LIANG Zhen-zhen;LV Hua-kun(Zhejiang Center for Disease Control and Prevention,Hangzhou,Zhejiang 310051,China)
出处
《中国国境卫生检疫杂志》
CAS
2022年第2期131-134,共4页
Chinese Journal of Frontier Health and Quarantine
基金
国家科技重大专项(2016ZX09101120-004)。
关键词
灭活疫苗
肠道病毒71型
免疫原性
抗体阳转率
不良反应
安全性
Inactivated vaccine
Enterovirus 71
Immunogenicity
Antibody positive conversion
Adverse recation
Safety
