脊髓灰质炎灭活疫苗(Sabin株)与Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗不同剂次基础免疫的免疫原性和安全性比较  

Immunogenicity and safety of Sabin strain-based inactivated poliovirus vaccine(sIPV)and typeⅠ+Ⅲ bivalent oral poliovirus vaccine(bOPV)administered in different schedules

作　　者：刘艳[1] 王骏[1] 许玉洋[1] 章国平[2] 江剑[2] 张学潮[1] 王芳 许二萍[1] Liu Yan;Wang Jun;Xu Yuyang;Zhang Guoping;Jiang Jian;Zhang Xuechao;Wang Fang;Xu Erping(Institute of Immunization and Prevention,Hangzhou Center for Disease Control and Prevention,Hangzhou 310021,China;Department of Immunization Program,Chun′an Center for Disease Control and Prevention,Hangzhou 311700,China)

机构地区：[1]杭州市疾病预防控制中心免疫预防所,310021 [2]淳安县疾病预防控制中心免疫规划科,杭州311700

出　　处：《中华微生物学和免疫学杂志》2020年第6期453-458,共6页Chinese Journal of Microbiology and Immunology

基　　金：浙江省基础公益研究计划项目(LGF18H260002);杭州市农业与社会发展科研计划项目(20180533B94)。

摘　　要：目的比较Sabin株脊髓灰质炎灭活疫苗(sIPV)与Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗(人二倍体细胞)(bOPV)液体剂型作为基础免疫以不同接种序贯接种于≥2月龄婴儿中的免疫原性和安全性。方法2017—2018年,采用随机、盲法、单中心、平行对照设计,选择杭州市≥2月龄的婴儿为研究对象,将其分为1sIPV+2bOPV组、2sIPV+1bOPV组和3sIPV组,按照2、3、4月龄的免疫程序,共接种3剂。记录受试者接种后发生的不良反应事件;全程免疫后28~35 d,采集排除脱落者和违背试验方案者血样,采用细胞培养微量中和试验测定抗脊髓灰质炎病毒Ⅰ、Ⅱ、Ⅲ型中和抗体几何平均滴度(GMT),计算抗体阳转率,并对其进行统计学分析。结果1sIPV+2bOPV组、2sIPV+1bOPV组和3sIPV组全部不良反应发生率分别为3.57%、3.61%和1.19%(χ^2=1.190,P=0.552),均为一般反应。全程免疫后,1sIPV+2bOPV组、2sIPV+1bOPV组和3sIPV组Ⅰ型脊髓灰质炎病毒抗体阳转率分别为100%(84/84)、100%(83/83)和100%(84/84),Ⅱ型分别为81%(68/84)、96%(80/83)和99%(83/84)(χ^2=21.469,P<0.001),Ⅲ型分别为100%(84/84)、100%(83/83)和100%(84/84);Ⅰ型脊髓灰质炎病毒抗体GMT分别为1024.00、1015.48和982.61(F=2.742,P=0.066),Ⅱ型分别为16.81、107.94和218.85(F=33.570,P<0.001),Ⅲ型分别为990.75、990.36和613.92(F=37.886,P<0.001)。结论不同脊髓灰质炎基础免疫程序中,sIPV和bOPV在≥2月龄的婴儿中均具有良好的安全性和免疫原性,2sIPV+1bOPV组和3sIPV组较1sIPV+2bOPV组产生更高的Ⅱ型脊髓灰质炎病毒抗体GMT和阳转率,1sIPV+2bOPV组和2sIPV+1bOPV组较3sIPV组产生更高的Ⅲ型脊髓灰质炎病毒抗体GMT。Objective To compare the safety and immunogenicity of Sabin strain-based inactivated poliovirus vaccine(sIPV)and the liquid form of typeⅠ+Ⅲbivalent oral poliovirus vaccine(bOPV)administered to infants aged≥2 months in different schedules.Methods A randomized,blinded,single-center,parallel-group controlled trial was conducted in Hangzhou from 2017 to 2018.Healthy infants aged≥2 months were enrolled and randomized to receive the vaccines on a schedule of 2,3,4 months.Group 1sIPV+2bOPV was given one dose of sIPV and two doses of bOPV;group 2sIPV+1bOPV was administrated two doses of sIPV and one dose of bOPV;group 3sIPV received three doses of sIPV.Adverse events(AEs)following vaccination were recorded.Blood samples were collected from the subjects(excluding the quitters or subjects against the trial plan)28-35 d after the full-course immunization.A microneutralization assay was performed to detect the geometric mean titers(GMTs)of neutralizing antibodies against polio virus ofⅠ,ⅡandⅢtypes.The seroconversion rates of neutralizing antibodies were also calculated.Results The overall incidence of AEs following vaccination was 3.57%in 1sIPV+2bOPV group,3.61%in 2sIPV+1bOPV group and 1.19%in 3sIPV group(χ^2=1.190,P=0.552)and no severe AEs were reported.The antibody seroconversion rates in 1sIPV+2bOPV,2sIPV+1bOPV and 3sIPV groups were respectively 100%(84/84),100%(83/83)and 100%(84/84)against typeⅠpoliovirus,81%(68/84),96%(80/83)and 99%(83/84)against typeⅡpoliovirus(χ^2=21.469,P<0.001),and 100%(84/84),100%(83/84)and 100%(84/84)against typeⅢpoliovirus.In 1sIPV+2bOPV,2sIPV+1bOPV and 3sIPV groups,the GMTs of antibody were 1024.00,1015.48 and 982.61 against typeⅠpoliovirus(F=2.742,P=0.066),16.81,107.94 and 218.85 against typeⅡpoliovirus(F=33.570,P<0.001),and 990.75,990.36 and 613.92 against typeⅢpoliovirus(F=37.886,P<0.001).Conclusions sIPV and bOPV administered in different schedules showed good safety and immunogenicity in infants aged≥2 months.The GMT and the seroconversion rate of neutralizing

关 键 词：脊髓灰质炎 脊髓灰质炎病毒疫苗 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]