肠道病毒71型中和抗体的保护水平  

Protection level of neutralizing antibody against enterovirus 71

作　　者：毛群颖[1] 高帆[1] 郝春生[2] 董承红[3] 高强[4] 王超 姚昕[1] 吴星[1] 邵杰[1] 朱凤才[6] 梁争论[1] 王军志[1] 

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京100050 [2]北京生物制品研究所有限责任公司第二研究室,北京100024 [3]中国医学科学院医学生物学研究所病毒免疫室,云南昆明650118 [4]北京科兴生物制品有限公司研发中心,北京100085 [5]华兰生物工程股份有限公司研发中心,河南新乡453003 [6]江苏省疾病预防控制中心,江苏南京210009

出　　处：《中国生物制品学杂志》2013年第2期166-170,共5页Chinese Journal of Biologicals

基　　金：国家"十二五"科技重大专项资助项目(2012ZX10004701)

摘　　要：目的通过检测乳鼠模型、健康婴幼儿和疫苗免疫后目标人群的肠道病毒71型(Enterovirus 71,EV71)中和抗体效价,为确定EV71疫苗保护水平提供基础数据。方法 6份不同EV71病毒株免疫血清经中和抗体准确定量后,分别通过两个EV71乳鼠攻毒模型,检测EV71中和抗体保护水平。采用标准化的中和抗体检测法和EV71中和抗体定值标准品,分别对健康婴幼儿及疫苗免疫后血清进行中和抗体准确定量。结果在2个乳鼠攻毒模型中,6份免疫血清的中和抗体保护水平接近,ED50分别为10～50 U和6.1～54.2 U;婴幼儿人群7、12和24月龄抗体阳性率分别为45.0%、48.8%和56.8%,阳性人群的抗体效价分别为113.8、120.3和330.6U/m(l均值为173.2 U/m)l,母亲抗体阳性率和效价分别为86.7%和114.3 U/ml;中、高剂量疫苗2针免疫后,婴幼儿抗体阳性率均为100%,效价为356.0和1 136.2 U/ml,较婴幼儿人群自然感染水平高2.1～6.6倍。结论应用标准化的中和抗体检测法和EV71中和抗体定值标准品,确定了以U/ml为单位的乳鼠攻毒抗体保护水平及婴幼儿人群抗体水平和疫苗免疫后抗体水平,为EV71疫苗免疫人群中和抗体保护水平的确定提供了依据。Objective To measure the neutralizing antibody titer against enterovirus 71 （EV71） in suckling mouse model, healthy infants and the target population after immunization and provide a basic data for determination of protection level of EV71 vaccine. Methods The neutralizing antibodies in six serum samples against various EV71 strains were quantified accurately, and evaluated for protection level by challenge test in two suckling mouse models. The neutralizing antibodies in serum samples of healthy infants and the target population after immunization were quantified aCcurately by standardized neutralization test in vitro and the standard substances for quantification of EVT1 neutralizing antibody. Results The protection levels of EV71 neutralizing antibodies in 6 serum samples were similar in challenge tests in two suckling mouse models, with EDW values of 10 - 50 U and 6. 1 - 54. 2 U, respectively. The antibody positive rates of infants at ages of 7, 12 and 24 months were 45. 0%, 48. 8% and 56. 8%, while the neutralizing antibody titers in antibody positive infants were 113.8, 120. 3 and 330. 6 U / ml （with a GMT of 173.2 U / ml）, respectively： However, the antibody positive rate and the neutralizing antibody titer were 86. 7% and 114. 3 U / ml respectively in the infant＇s mothers. After immunization with two doses of vaccine at high and moderate dosages, the neutralizing antibody positive rates in infants were 100%, while the neutralizing antibody titers were 356. 0 and 1 136. 2 U / ml, respectively, which were 2. 1 - 6. 6 times higher than those in infants infected naturally. Conclusion The protection levels of EV71 neutralizing antibody on suckling mouse model, infants and the target population after EV71 vaccination were quantified as the unit of U /ml by using standardized neutralization test in vitro and the standard substances for quantification of EV71 neutralizing antibody, which provided a basis for determination of protection level of neutralizing antibody in vaccinated population.

关 键 词：手足口病 肠道病毒A型 人 中和抗体 

分 类 号：R373.2[医药卫生—病原生物学] R392.33[医药卫生—基础医学]