肠道病毒71型灭活疫苗(Vero细胞)接种5年免疫持久性观察  

Five-year immunity persistence following immunization with inactivated enterovirus 71 vaccine(Vero cell)

作　　者：鲁卫卫 孟繁岳[2] 郭会杰 郝春生 毛群颖[3] 高帆[3] 卞莲莲[3] 段凯 陈晓琦 李新国 陈伟 陶红[2] 张良豪 陈金华 李秀玲 Lu Weiwei;Meng Fanyue;Guo Huijie;Hao Chunsheng;Mao Qunying;Gao Fan;Bian Lianlian;Duan Kai;Chen Xiaoqi;Li Xinguo;Chen Wei;Tao Hong;Zhang Lianghao;Chen Jinhua;Li Xiuling(No.2 Research Department,National Vaccine&Serum Institute,Beijing 101111,China;Institute of Clinical Evaluation of Vaccines,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China;Hepatitis Virus Research Department,National Institutes for Food and Drug Control,Beijing 102629,China;Research and Development Department,Wuhan Institute of Biological Products Co.,Ltd.,Wuhan 430070,China;Medical Affairs Department,Wuhan Institute of Biological Products Co.,Ltd.,Wuhan 430070,China;Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China)

机构地区：[1]国药中生生物技术研究院有限公司第二研究室,北京101111 [2]江苏省疾病预防控制中心疫苗临床评价所,南京210009 [3]中国食品药品检定研究院肝炎病毒室,北京102629 [4]武汉生物制品研究所有限责任公司科研开发部,430070 [5]武汉生物制品研究所有限责任公司医学事务部,430070 [6]上海生物制品研究所有限责任公司,201403

出　　处：《国际生物制品学杂志》2020年第6期261-266,共6页International Journal of Biologicals

基　　金：国家科技重大专项"重大新药创制"(2016ZX09101120)。

摘　　要：目的:观察肠道病毒71型(enterovirus 71,EV71)疫苗接种后5年的免疫持久性。方法:在Ⅲ期临床试验免疫原性亚组中,对完成全程两针次免疫的、免前抗EV71中和抗体阴性人群进行免疫后5年采血,并检测抗EV71中和抗体评价免疫持久性。完整检测时间点包括0、56 d和8、14、26、64个月。采用t检验和卡方检验分析数据。结果:疫苗组和安慰剂对照组分别有235和255名受试者具有全部检测点的中和抗体数据。接种后64个月,疫苗组抗EV71中和抗体几何平均滴度(369.57)高于对照组(55.58),且差异有统计学意义(t=14.28,P<0.01);分别以抗体滴度8、16、32为阳性判定标准,疫苗组抗体阳性率(100%、99.57%、97.87%)均高于对照组(69.02%、61.96%、59.61%)且差异有统计学意义(χ2分别为107.93、133.14、130.69,P值均<0.01)。疫苗接种后其他检测时间点的结果与64个月类似。结论:该EV71疫苗两针基础免疫后能够诱导较高的中和抗体水平和阳性率,在免疫后5年依然保持较好的免疫持久性。Objective To investigate the immunity persistence five-year post vaccination of inactivated enterovirus 71(EV71)vaccine.Methods Among the immunogenicity cohort in phaseⅢtrial,blood samples were collected from a subset of participants having fulfilled 2-dose vaccination protocol,and whose serum EV71 neutralizing antibody(NAb)assay was negative on day 0.NAb was tested to evaluate immunity persistence.The full series of sampling time points included days 0 and 56,as well as months 8,14,26,and 64.Data were analyzed by t-test and chi-square test.Results There were 235 subjects in vaccine group and 255 in placebo control group who had full series of sampling points results.At 64-month post vaccination,the geometric mean titer(GMT)of anti-EV71 NAb in vaccine group(369.57)was higher than that in control group(55.58),and the difference was statistically significant(t=14.28,P<0.01).By the cutoff NAb titer values of 8,16,32,at month 64,the seropositive rates in vaccine group(100%,99.57%,97.87%)were higher than those in control group(69.02%,61.96%,59.61%),and the differences were statistically significant(chi-square values were 107.93,133.14,130.69,respectively;all P values<0.01).The results at other observed time points post vaccination were similar with those at month 64.Conclusion The EV71 vaccine induces a sustained high level of NAb GMTs andseropositive rates against EV71 for at least 5 years.

关 键 词：肠道病毒71型灭活疫苗 中和抗体 免疫持久性 

分 类 号：R186[医药卫生—流行病学]