Sabin株脊髓灰质炎灭活疫苗安全性及免疫原性  

Safety and immunogenicity of an inactivated poliovirus vaccine made from Sabin strains

作　　者：唐蓉[1] 梁祁[1] 李贵凡[2] 智恒奎 王建军 胡月梅[1] TANG Rong;LIANG Qi;LI Gui-fan(Department of Vaccine Clinical Evaluation,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing,Jiangsu Province 210009,China;不详)

机构地区：[1]江苏省疾病预防控制中心疫苗临床评价所,江苏南京210009 [2]北京民海生物科技有限公司 [3]盐城市大丰区疾病预防控制中心

出　　处：《中国公共卫生》2020年第10期1450-1454,共5页Chinese Journal of Public Health

摘　　要：目的评价Sabin株脊髓灰质炎灭活疫苗(sIPV)的安全性和免疫原性。方法2017年8月—2018年4月,选择江苏省盐城市大丰区2月龄的常住健康婴儿,在Ⅰb期临床试验中,20名2月龄婴儿接种高剂量sIPV试验疫苗;在Ⅰ期临床试验中,60名2月龄婴儿按1:1:1的比例随机接种低剂量sIPV试验疫苗、sIPV对照疫苗或野毒株脊髓灰质炎灭活疫苗(wIPV)。对受试者进行安全性观察,并采集受试者免疫前和全程免疫后30 d的血清样本进行免疫原性观察。结果高、低剂量组、s IPV对照组和wIPV对照组中,总体征集性不良反应发生率分别为70.0%、55.0%、65.0%和50.0%,以1级(轻度)不良反应为主;Ⅰ型中和抗体几何平均滴度(GMT)分别为2007.47、2070.22、1580.56和364.70,Ⅱ型中和抗体GMT分别为700.26、477.52、220.98和159.75,Ⅲ型中和抗体GMT分别为366.21、522.75、289.64和306.74。结论低、高剂量s IPV试验疫苗在2月龄婴儿人群中具有良好的安全性,且免疫原性优于2个对照疫苗。Objective To evaluate the safety and immunogenicity of an inactivated poliovirus vaccine made from Sabin strains(sIPV).Methods In Dafeng county of Jiangsu province,China,we recruited healthy infants aged 2 months for clinical trials between August 2017 and April 2018.In a phaseⅠb clinical trial,20 participants received the high-dose sIPV.In another phaseⅠclinical trial,60 participants were randomized into three groups at a ratio of 1:1:1 to receive one of the three different vaccines:the low-dose sIPV,the control sIPV,or the IPV made from wild-type strains(wIPV).Follow-up observations on adverse effects after the vaccinations were conducted among all the participants and serum samples of the participants were obtained before the first dose and the day 30 after the full dose immunization for microneutralization assays.Results The overall incidence of reported adverse effects after 3 dose vaccinations in the groups of high-dose sIPV,low-dose sIPV,control sIPV and control wIPV were 70.0%,55.0%,65.0%and 50.0%,respectively.The majority of the adverse effects were all of gradeⅠ(mild).After the 3 dose vaccinations,the geometric mean titer(GMT)of the microneutralization antibodies in the groups of high-dose sIPV,low-dose sIPV,control sIPV and control wIPV were 2007.47,2070.22,1580.56 and 364.70 for poliovirus type 1;700.26,477.52,220.98 and 159.75 for poliovirus type 2;366.21,522.75,289.64 and 306.74 for poliovirus type 3,respectively.Conclusion Both the low-dose and high-dose sIPV showed a good safety and a better immunogenicity compared with the other two control vaccines when used among 2-month old infants.

关 键 词：Sabin株脊髓灰质炎灭活疫苗 安全性 免疫原性 

分 类 号：R186.7[医药卫生—流行病学]