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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 provide basic data for determining the level of EV71 vaccine protection by detecting the neutralizing antibody titer of enterovirus 71 (EV71) in the target population of healthy infants and vaccinated mice. Methods After the serums of 6 different EV71 strains were accurately quantified by neutralizing antibodies, the protective effects of EV71 neutralizing antibody were detected by two EV71 suckling mice. Standard neutralizing antibody and EV71 neutralizing antibody standards were used to quantify the neutralizing antibodies in healthy infants and post-vaccination sera respectively. Results The neutralization antibody levels of 6 immune sera in two suckling rat models were similar, with ED50 values of 10-50 U and 6.1-54.2 U respectively. The positive rates of antibodies at 7, 12 and 24 months of infants and young children were respectively Were 45.0%, 48.8% and 56.8%, respectively. The antibody titer of the positive population was 113.8, 120.3 and 330.6 U / m, respectively (l mean 173.2 U / m). The positive rates and titers of maternal antibodies were 86.7% and 114.3 U / ml; medium and high doses of vaccine 2 needle immunization, the positive rate of infant antibodies were 100%, the titer of 356.0 and 1 136.2 U / ml, than the natural infection of infants and young children 2.1 to 6.6 times higher levels. Conclusions The standard antibody against neutralizing antibody of neutralizing antibody EV71 was used to determine the protection level of antibodies in U / ml and the level of antibody in infant population and antibody after immunization. Provided a basis for the determination of the level of protection of neutralizing antibodies against the vaccinated population.