6-35月龄儿童接种肠道病毒71型灭活疫苗的手足口病保护效果和不良反应观察

Effectiveness of inactivated enterovirus type 71 vaccine against hand,foot and mouth disease and adverse reactions among 6-35-month-old children

目的 评价肠道病毒71型(Enterovirus type 71,EV71)灭活疫苗预防手足口病(Hand, foot and mouth disease, HFMD)的效果和安全性。方法 在温州市鹿城区招募6-35月龄儿童,按0-1月免疫程序接种2剂次EV71疫苗或不接种EV71疫苗,观察1年内HFMD发病和不良反应发生情况,计算EV71疫苗预防HFMD的疫苗效果(Vaccine effectiveness, VE)和接种后不良反应发生率。结果 接种组、未接种组儿童HFMD发病率分别为0.14%(21/14 720)、3.86%(160/4 140)(χ^(2)=470.96,P=0.000),EV71疫苗预防HFMD的总VE为86.88%(95%CI:81.96%-91.79%)。儿童接种EV71疫苗后不良反应发生率为1.29‰(38/29 440),其中局部、全身反应发生率分别为0.95‰(28例)、0.88‰(26例),Ⅰ级、Ⅱ级、Ⅲ级、Ⅳ级不良反应发生率分别为0.71‰(21例)、0.51‰(15例)、0.07‰(2例)、0.00‰。结论 6-35儿童接种EV71疫苗具有良好的HFMD保护效果和安全性。

Objective To evaluate inactivated enterovirus type 71(EV71) vaccine effectiveness against hand, foot and mouth disease(HFMD) and safety among 6-35-month children.Methods We recruited 6-35-month old children in Lucheng district of Wenzhou city. Children received 2 doses of EV71 vaccine in a 0-1-month vaccination schedule or did not received any EV71 vaccine. We conducted one year of follow-up for HFMD incidence and adverse reactions after vaccination to determine vaccine effectiveness(VE) against HFMD and incidences of adverse reactions.Results The incidence of HFMD was 0.14%(21/14 720) in the vaccinated group and 3.86%(160/4 140) in the unvaccinated group(χ^(2)=470.96, P=0.000). The overall VE against HFMD of EV71 vaccine was 86.88%(95%CI: 81.96%-91.79%). The overall incidence of adverse reactions after EV71 vaccination in children was 1.29‰(38/29 440), with 0.95‰(28 cases) and 0.88‰(26 cases) local and systemic reactions and 0.71‰(21 cases), 0.51‰(15 cases), 0.07‰(2 cases), and 0.00‰ grade 1, 2, 3, and 4 reactions.Conclusions EV71 vaccine showed good effectiveness against HFMD and had a favorable safety profile among 6-35-month children.