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目的 调查山东省临沂市适龄儿童接种肠道病毒A组71型(Enterovirus A71,EV-A71)灭活疫苗后，血清中EV-A71中和抗体阳性率、抗体几何平均滴度(GMT)和抗体持续时间，了解EV-A71灭活疫苗的实际免疫保护效果，为山东省精准防控手足口病提供EV-A71疫苗免疫效果的数据支持。方法 采用分层随机抽样方法，于2020年在山东省临沂市8个区(县)选取7岁以内已接种2剂次EV-A71灭活疫苗的195名儿童，作为疫苗接种组的研究对象；同时选取195名未接种过疫苗且无手足口病发病史的儿童，作为对照组研究对象。收集研究对象的姓名、性别、年龄、疫苗接种时间、手足口病发病史等信息，由家长填写《儿童家长EV-A71疫苗认知和接种意愿调查问卷》，并签署知情同意书。采集血标本后，分离血清，通过经典细胞微量中和试验方法测定血清中EV-A71中和抗体滴度，计算抗体阳性率和几何平均滴度(Geometric mean titer, GMT)，不同组间EV-A71血清中和抗体总阳性率的比较用卡方检验，GMT的比较则使用配对样本t检验和单因素方差分析。结果 接种组和对照组EV-A71血清中和抗体总阳性率分别为95.90%和62.56%；中和抗体GMT分别为60.46(95%CI:49.24～74.24)和9.49(95%CI8.40～10.71)。疫苗接种组的EV-A71血清中和抗体总阳性率显著高于对照组(χ2=65.83,P<0.0001)，且疫苗接种组的GMT也显著高于对照组(t=7.032,P<0.001)。性别和初次接种疫苗的月龄对EV-A71血清中和抗体阳性率和GMT均无影响。随着接种时间的推移，EV-A71血清中和抗体GMT水平呈现逐年下降的趋势，其GMT水平从半年内的174.9(95%CI:101.7～300.5)，在两年半后下降至48.03(95%CI:34.82～66.23)，尤其是在接种2.5年后，GMT水平下降趋势尤为明显。尽管如此，接种疫苗2.5年后的GMT水平48.03(95%CI:34.82～66.23)仍远高于对照组GMT水平9.49,(95%CI:8.40～10.71)(P<0.001)，说明接种两剂次EV-A71灭活疫苗在两年半内仍然具有良好的保护效果。结论 EV-A71灭活疫苗在适龄儿童免疫中，表现出较高的阳性率和GMT水平，具有良好的免疫保护效果。然而，为了维持较高的抗体滴度水平，建议在初次接种后的两至三年进行加强免疫，以持续保障疫苗的防护效力。
Abstract：This study investigated the seropositivity rate, geometric mean titers(GMTs), and persistence of enterovirus A71(EV-A71) neutralizing antibodies among children in Linyi City, Shandong Province,China, following administration of the EV-A71 vaccine, with the aim of evaluating its real-world protective efficacy. Using stratified random sampling, 195 children under seven years of age who had received two doses of the vaccine were recruited as the vaccination group, while 195 unvaccinated children without a history of hand, foot, and mouth disease(HFMD) were enrolled as controls. Baseline demographic information and vaccination history were collected through parent questionnaires, and blood samples were obtained after informed consent. Neutralizing antibody titers were determined using the standard micro-neutralization assay, and antibody seropositivity rates and GMTs were calculated and statistically compared. The results showed that the vaccination group exhibited a significantly higher antibody seropositivity rate(95.90%) than the control group(62.56%) (χ2 = 65.83, P < 0.0001), with GMTs of 60.46(95% CI: 49.24– 74.24) and 9.49(95% CI: 8.40 – 10.71), respectively(t = 7.032, P < 0.001). Neither sex nor age at first vaccination significantly influenced antibody seropositivity or GMTs. Over time, antibody GMTs declined from 174.9(95% CI: 101.7– 300.5) within six months post-vaccination to 48.03(95%CI: 34.82-66.23) at 2.5 years, with a particularly pronounced decrease after 2.5 years. Despite this decline, the GMTs at 2.5 years remained significantly higher than those in the control group(P < 0.001), indicating sustained immune protection. These findings demonstrate that two doses of the inactivated EV-A71 vaccine elicit high seropositivity rates and robust antibody titers in children, providing effective protection for at least 2.5 years. Given the observed decline in antibody titers, a booster dose administered approximately two to three years after the primary series may be necessary to maintain long-term protective efficacy.
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基本信息:
DOI：10.13242/j.cnki.bingduxuebao.250161
中图分类号:R186
引用信息:
[1]王建醒,张晓丽,刘晓林,等.肠道病毒A组71型灭活疫苗免疫效果及其持久性评估[J].病毒学报,2026,42(02):393-400.DOI:10.13242/j.cnki.bingduxuebao.250161.
基金信息:
山东省医药卫生科技发展计划（项目号：202012061392）,题目：山东省手足口病重症病例流行规律及病原构成研究;山东省医药卫生科技发展计划（项目号：202112050747）,题目：疫情常态化防控背景下山东省手足口病流行特征分析~~
2025-09-23
2025-09-23
2025-09-23