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肠道病毒71型灭活疫苗免疫后不同时间点中和抗体动态变化情况

Dynamics of neutralizing antibody titers at different time points after immunization with enterovirus type 71 vaccin

摘要:

目的 观察肠道病毒71型灭活疫苗(简称“EV71疫苗”)免疫后不同时间点中和抗体动态变化情况.方法 采用随机、开放式临床试验设计,在浙江省上虞区选择120名6~35月龄婴幼儿作为研究对象,按年龄分层随机分为3组,分别在疫苗1剂次接种后10d、20 d、30 d采集受试者血清,检测EV71中和抗体水平,评价EV71疫苗快速产生抗体能力.采用开放式设计,以2012年江苏省EV71疫苗Ⅲ期临床试验的343名受试者为研究对象,在疫苗首针免疫后64个月采集受试者静脉血进行EV71中和抗体检测,评价EV71疫苗5年免疫持久性.结果 疫苗快速产生抗体研究结果显示,受试者免疫前抗体阳性率为3.8%(4/104),免前抗体几何平均滴度(GMT)为1∶5.0,接种1剂次EV71疫苗后10d、20 d、30 d时抗体阳性率分别达到89.2%(33/37)、80.6%(25/31)和66.7%(24/36),GMT分别为1∶24.6、1∶12.9和1∶13.8;各时间点抗体阳性率(Fisher精确概率法,P< 0.01)和GMT(Z10=-5.03,Z20=-3.73,Z30=-4.31,P值均<0.01)均高于免疫前,差异均有统计学意义.5年免疫持久性研究结果显示,免疫后64个月疫苗组和安慰剂组的EV71抗体阳性率分别为94.3%(100/106)和71.4%(75/105),疫苗组抗体阳性率高于安慰剂组,差异有统计学意义(x2=19.57,P<0.01);GMT分别为1∶141.4和1∶71.8,疫苗组抗体GMT高于安慰剂组,差异有统计学意义(t=2.60,P=0.01).结论 EV71疫苗接种人体后能快速产生抗体,并且具有较好的免疫持久性.

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abstracts:

Objective To observe the dynamics of neutralizing antibody titers at different time points after immunization with enterovirus type 71 (EV71) vaccine.Methods A randomized,open-label clinical trial was conducted.One hundred and twenty infants aged 6-35 months in Zhejiang province were recruited as subjects and were randomly divided into 3 groups.The serum was collected at 10 days,20 days,and 30 days after 1 dose of EV71 vaccine in each group.EV71 neutralizing antibody was detected to study immunogenicity at different time points after initial immunization with EV71 vaccine.An open-label design was conducted to study 343 subjects in phase Ⅲ clinical trials in Jiangsu province in 2012.Venous blood samples were collected to detect EV71 neutralizing antibodies 64 months after the first dose of vaccine was administered,so as to evaluate the antibody persistence over 5 years.Results The results of the Zhejiang study showed that the seropositive rate before inoculation was only 3.8%(4/104).Pre-immune antibody geometric mean titer (GMT) was 1∶5.0.The seropositive rates of EV71 vaccine antibody at day 10,20 and 30 after inoculation with 1 dose of EV71 reached 89.2% (33/37),80.6% (25/31) and 66.7% (24/36),respectively and the GMTs were 1∶24.6,1∶1∶12.9,and 1∶13.8,respectively.The seropositive rates (P<0.01) and GMT (Z10=-5.03,Z20=-3.73,Z30=-4.31,all P<0.01) at each time point were statistically higher than those before vaccination;The results of the Jiangsu study showed that the seropositive rates were 94.3% (100/106) and 71.4% (75/105) at 64-month in vaccine group and placebo group,respectively.The indicator was statistically higher in the vaccine group than that in the placebo group (x2=19.567,P<0.01).The GMT was 1∶141.4 and 1∶71.8,respectively and the indicator was statistically higher in the vaccine group than in the placebo group (t=2.60,P=0.01).Conclusions EV71 vaccine can stimulate immune response quickly after vaccination and showed good persistence over five years.

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