接种后肠道病毒 71 型中和抗体的短期动态变化。
Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination.
机构信息
Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.
Clinical Research Department, Sinovac Biotech Co., Ltd , Beijing, China.
出版信息
Hum Vaccin Immunother. 2020 Jul 2;16(7):1595-1601. doi: 10.1080/21645515.2020.1711678. Epub 2020 Jan 24.
BACKGROUND
Short-term dynamic changes in neutralizing antibodies against EV71 and EV71-IgM after inactivated EV71 vaccine injection are unknown.
METHODS
This study was designed as a randomized, open-label study and was registered at ClinicalTrials.gov (NCT03278132). In total, 120 healthy infants aged 6-35 months were randomized 1:1:1 to provide a second blood sample on day 10, day 20, or day 30 after the first vaccine dose, respectively.
RESULTS
According to the per-protocol set, a rapid immune response against EV71 was observed 10 days after the first EV71 vaccine dose, with antibody titers ≥1:8 in 89.19% of participants (95% CI: 74.58-96.97%) on day 10, in 80.65% (95% CI: 62.53-92.55%) on day 20, in 66.67% (95% CI: 49.03-81.44%) on day 30, and in 100% (95% CI: 96.52%-.) on day 60. Based on an ELISA, the percentages of participants positive for EV71-IgM on day 0 and day 60 were 1.71% (2 out of 117) and 82.86% (87 out of 105), respectively.
CONCLUSIONS
The EV71 vaccine could be used for contingency vaccination to further control EV71-associated disease outbreaks. Caution should be taken in using the EV71-IgM test for rapid EV71 infection diagnosis after EV71 vaccine administration.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT03278132.
背景
关于接种灭活肠道病毒 71 型（EV71）疫苗后中和抗体的短期动态变化和 EV71-IgM 的变化情况尚不清楚。
方法
本研究为随机、开放标签研究，在 ClinicalTrials.gov 注册（NCT03278132）。共纳入 120 名 6-35 月龄健康婴儿，按照 1∶1∶1 的比例随机分为三组，分别于首针后第 10、20、30 天采集血样。
结果
根据方案设定，首针 EV71 疫苗接种后 10 天，89.19%（95%CI：74.58%-96.97%）的参与者中和抗体滴度≥1∶8，第 20 天为 80.65%（95%CI：62.53%-92.55%），第 30 天为 66.67%（95%CI：49.03%-81.44%），第 60 天为 100%（95%CI：96.52%-100%）。采用酶联免疫吸附试验（ELISA）法检测 EV71-IgM，第 0 天和第 60 天的阳性率分别为 1.71%（2/117）和 82.86%（87/105）。
结论
EV71 疫苗可用于应急接种，进一步控制 EV71 相关疾病的暴发。接种 EV71 疫苗后，应谨慎使用 EV71-IgM 检测进行快速 EV71 感染诊断。
临床试验注册
ClinicalTrials.gov，NCT03278132。
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