1~12岁儿童接种国产冻干水痘减毒活疫苗的安全性和免疫效果评价

Evaluation of safety and immune efficacy of domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years

目的:了解1~12岁儿童接种国产1剂次冻干水痘减毒活疫苗后的安全性和免疫原性。方法:2018年10月至2020年12月在河北省疫苗临床试验基地采用随机、盲法、同类疫苗对照的非劣效临床试验设计开展临床研究,研究对象为1~12岁健康儿童,共计1080名,按1∶1的比例随机分配到试验组和对照组,分别接种1剂试验疫苗(北京万泰生物药业股份有限公司)和对照疫苗(上海生物制品研究所有限责任公司),观察疫苗接种后30 d内的不良反应,在接种疫苗前和接种疫苗后30 d分别采集儿童2.5~3.0 mL静脉血,采用膜抗原荧光抗体法(FAMA)检测抗水痘病毒抗体,并计算抗体阳转率及几何平均滴度(GMT)。结果:试验组的抗体阳转率96.00%(240/250),高于对照组的88.74%(χ^(2)=9.128,P<0.01);试验组人群阳转率(4倍增长)为92.95%(501/539),高于对照组的78.52%(χ^(2)=45.915,P<0.01);试验组GMT为192.42(167.92~220.50),高于对照组的85.65(73.29~100.09)(t=7.683,P<0.01);试验组抗体GMT≥1∶128的比例为61.97%,高于对照组的38.33%(χ^(2)=60.266,P<0.01)。试验组总体不良反应发生率为24.12%(130/539),对照组为26.48%(143/540),两组比较差异无统计学意义(P>0.05),常见的局部不良反应以发红、肿、疼痛为主。两组均未发生与疫苗接种有关的严重不良事件。结论:在1~12岁儿童中进行国产1剂次冻干水痘减毒活疫苗免疫,具有较高的安全性和免疫原性。

Objective To evaluate the safety and immune efficacy of 1-dose domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years.Methods A randomized,double-blind,positive-controlled,non-inferiority clinical trial was conducted in Hebei vaccine clinical research base from October 2018 to December 2020.The subjects were 1080 children aged 1-12 years,who were assigned in a 1:1 ratio to receive the test vaccine(Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd)and control vaccine(Shanghai Institute of Biological Products Co.,Ltd).Adverse reactions within 30 days after vaccination were observed.Before and 30 days after vaccination,2.5-3.0 mL of venous blood was collected,respectively.The anti-varicella virus antibody was detected by fluorescent antibody to membrane antigen(FAMA),and the positive conversion rate and geometric average titer(GMT)of the antibody were calculated.Results The antibody positive conversion rate in the experimental group was 96.00%(240/250),which was higher than that of 88.74%in the control group(X^(2)=9.128,P<0.01).The positive conversion rate(4 times increase)in the experimental group was 92.95%(501/539),which was higher than that of 78.52%in the control group(X^(2)=45.915,P<0.01).The GMT in the experimental group was 192.42(167.92-220.50),which was higher than that of 85.65(73.29-100.09)in the control group(X^(2)=7.683,P<0.01).The proportion of antibody GMT^1:128 in the experimental group was 61.97%,which was higher than that of 38.33%in the control group(X^(2)=60.266,P<0.01).The incidence rates of overall adverse reactions were 24.12%(130/539)in experimental group and 26.48%(143/540)in control group,and the difference was not statistically significant(P>0.05).The common local adverse reactions were redness,swelling and pain.No severe adverse reaction happened in both groups.Conclusions The immunogenicity and safety of 1-dose domestic lyophilized live attenuated varicella vaccine in children aged 1-12 years are all good.