a School of Public Health , Nanjing Medical University , Nanjing , PR China.
c Sinovac Biotech , Beijing , PR China.
Expert Rev Vaccines. 2018 Mar;17(3):257-262. doi: 10.1080/14760584.2018.1430572. Epub 2018 Jan 29.
The Sinovac enterovirus 71 (EV71) vaccine has shown good safety, immunogenicity, and efficacy in infants aged 6-35 months, whom are considered as the priority of the target population. However, 3-5 years old children accounted for approximately 30% of HFMD cases and are also worth our attention.
A randomized, double-blind, placebo-controlled, batch-to-batch consistency clinical trial enrolling 1400 participants aged 6-59 months was performed. We pooled the participants receiving three batches of EV71 vaccine together and then stratified them into the 6-35 months and 3-5 years. The non-inferiority analysis of the geometric mean titer (GMT) of EV71 neutralizing antibody post-vaccination was the primary endpoint.
In the vaccine group, the GMT of 242 children aged 3-5 years was 132.72 (95% CI, 110.3-159.6), which was non-inferior to that generated in 717 infants aged 6-35 months. Following the vaccination, the incidence of adverse reactions was less frequent in children aged 3-5 years (47.0%) than that found in infants aged 6-35 months (60.1%) (p = 0.0026).
Our study indicated that the EV71 vaccine was also safe in children aged 3-5 years, with non-inferior immunogenicity to that in infants aged 6-35 months.
科兴肠道病毒 71 型（EV71）疫苗已在 6-35 月龄婴儿中显示出良好的安全性、免疫原性和有效性，这些婴儿被认为是目标人群中的优先人群。然而，3-5 岁儿童约占手足口病病例的 30%，也值得我们关注。
一项纳入 1400 名 6-59 月龄参与者的随机、双盲、安慰剂对照、批对批一致性临床试验进行。我们将接受三批 EV71 疫苗的参与者汇总在一起，然后将其分为 6-35 月龄和 3-5 岁组。接种后 EV71 中和抗体几何平均滴度（GMT）的非劣效性分析是主要终点。
在疫苗组中，242 名 3-5 岁儿童的 GMT 为 132.72（95%CI，110.3-159.6），与 717 名 6-35 月龄婴儿产生的 GMT 相当。接种后，3-5 岁儿童不良反应发生率（47.0%）低于 6-35 月龄婴儿（60.1%）（p=0.0026）。
本研究表明，EV71 疫苗在 3-5 岁儿童中也安全，免疫原性与 6-35 月龄婴儿相当。
