肠道病毒71型灭活疫苗(Vero细胞)安全性分析
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摘要
目的观察6月龄～3周岁儿童人群接种肠道病毒71型灭活疫苗(Vero细胞)(以下简称EV71疫苗)的安全性。方法通过主动监测与被动监测相结合的方式,观察受种者EV71疫苗接种后30d内发生的不良事件,采用描述性流行病学方法分析其特征。结果 4 077名儿童受种者,接种7 952剂EV71疫苗,其中第1剂4 077人,第2剂3 875人,共观察到接种后30d内发生的不良事件102例,总体不良事件发生率1.28/100剂,其中第1剂1.55/100剂,第2剂1.01/100剂,剂次间差异无统计学意义(χ~2=4.555,P=0.033)。接种局部可出现红、痛、疹、硬结、肿,发生率间差异无统计学意义,全身不良事件以发热、疲倦乏力、食欲下降、上呼吸道感染占优势,全身不良事件较局部发生率为高,不良事件发生与接种时间间隔以24h内(85.53%)多见,所有不良事件以1、2级(92.11%)为主,3级不良事件以发热(83.33%)为主,未发现致残致死或并发症等严重危及受种者身体健康的不良事件,所有不良事件经对症处理后均在7d内痊愈。结论在6月龄～3周岁儿童中实施EV71灭活疫苗接种具有较好的安全性。
Objective To investigate the safety of the inoculation of the inactivated Vero cell-based Enterovirus 71(EV71) vaccine in children aged from 6 months to 3 years old. Methods The adverse events occurring within 30 days after the vaccination of the EV71 vaccine were observed through the combination of active surveillance and passive monitoring, and the characteristics were analyzed by descriptive epidemiologic methods. Results A total of 4 077 children were vaccinated with 7 952 doses of EV71 vaccine, including the first doses of 4 077 and the second doses of 3 975. 102 adverse events were reported within 30 days after vaccination. The overall adverse event was 1.28/100 doses. Percentages of adverse events for the first and second doses were 1.55% and 1.01%, respectively. There was no statistical difference between the two doses(χ~2=4.555, P=0.033). The local adverse events were reported to include redness, pain, rash, induration, and swelling, and there was no difference among these incidences. The systemic adverse events included fever, weakness, loss of appetite, and upper respiratory tract infections. There were more systemic adverse events than local adverse eventsThe adverse events occurred more commonly within 24 hours(85.53%) after vaccination. All adverse events were mainly grade 1 or 2(92.11%). Grade 3 adverse events were mainly fever(83.33%). No other serious adverse events such as disability, death or complications, that seriously endanger the health of the recipient were reported. All adverse events were cured within 7 days after symptomatic treatment. Conclusion EV71 inactivated vaccination is safe in children between 6 months and 3 years of age.
Objective To investigate the safety of the inoculation of the inactivated Vero cell-based Enterovirus 71(EV71) vaccine in children aged from 6 months to 3 years old. Methods The adverse events occurring within 30 days after the vaccination of the EV71 vaccine were observed through the combination of active surveillance and passive monitoring, and the characteristics were analyzed by descriptive epidemiologic methods. Results A total of 4 077 children were vaccinated with 7 952 doses of EV71 vaccine, including the first doses of 4 077 and the second doses of 3 975. 102 adverse events were reported within 30 days after vaccination. The overall adverse event was 1.28/100 doses. Percentages of adverse events for the first and second doses were 1.55% and 1.01%, respectively. There was no statistical difference between the two doses(χ~2=4.555, P=0.033). The local adverse events were reported to include redness, pain, rash, induration, and swelling, and there was no difference among these incidences. The systemic adverse events included fever, weakness, loss of appetite, and upper respiratory tract infections. There were more systemic adverse events than local adverse eventsThe adverse events occurred more commonly within 24 hours(85.53%) after vaccination. All adverse events were mainly grade 1 or 2(92.11%). Grade 3 adverse events were mainly fever(83.33%). No other serious adverse events such as disability, death or complications, that seriously endanger the health of the recipient were reported. All adverse events were cured within 7 days after symptomatic treatment. Conclusion EV71 inactivated vaccination is safe in children between 6 months and 3 years of age.
引文
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[10] 戴莹,雷亚克,黄丹钦,等. 2010—2015年湖北省手足口病流行病学特征[J]. 职业与健康,2017,33(17):2387-2390.
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[12] ZHU F,XU W,XIA J,et al.Efficacy,safety,and immunogenicity of an enterovirus 71 vaccine in China[J].New England Journal of Medicine,2014,370(9):818-828.
[13] GU W,ZENG G,HU YM,et al.A comparative analysis of immunogenicity and safety of an enterovirus 71 vaccine between children aged 3～5 years and infants aged 6～35 months[J]. Expert Review of Vaccines,2018,17(3):1234-1254.
[14] 王雷,王四全,胡樱,等. 湖北省2016—2017年肠道病毒71型灭活疫苗上市后安全性[J]. 中国疫苗和免疫,2018(4):471-474.
[2] XING W,LIAO Q,Viboud C,et al.Hand,foot,and mouth disease in China,2008-12:an epidemiologicalstudy[J]. Lancet Infectious Diseases,2014,14(4):308-318.
[3] 袁春燕,周义红,吴惠,等. 2010—2014年江苏常州市武进区手足口病流行病学特征分析[J]. 公共卫生与预防医学,2016,27(6):100-102.
[4] Solomon T,Lewthwaite P,Perera D,et al.Virology,epidemiology,pathogenesis,and control of enterovirus 71[J]. Lancet Infectious Diseases,2010,10(11):778-790.
[5] LIANG Z,WANG. EV71 vaccine,an invaluable gift for children[J].Clin Transl Immunology,2014,3(10):e28.
[6] 武文娣,刘大卫. 疫苗上市后安全性主动监测及其流行病学研究方法[J].中国疫苗和免疫,2016(2):221-229.
[7] 钱素云,李兴旺. 我国手足口病流行及诊治进展十年回首[J].中华儿科杂志,2018,56(5): 321-323.
[8] 王丹,李法锦,姚光海,等. 贵州省2009—2016年手足口病流行病学特征研究[J]. 中国疫苗和免疫,2017(4):450-454.
[9] 程学森,王东艳,张勇,等. 内蒙古自治区2008—2015年手足口病流行病学特征及病原学分析[J]. 中国病毒病杂志,2017(2):107-112.
[10] 戴莹,雷亚克,黄丹钦,等. 2010—2015年湖北省手足口病流行病学特征[J]. 职业与健康,2017,33(17):2387-2390.
[11] WEI M,MENG F,WANG S,et al.2-Year Efficacy,Immunogenicity,and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children:A Randomized Open-Label Study[J].Journal of Infectious Diseases,2017,215(1):56-63.
[12] ZHU F,XU W,XIA J,et al.Efficacy,safety,and immunogenicity of an enterovirus 71 vaccine in China[J].New England Journal of Medicine,2014,370(9):818-828.
[13] GU W,ZENG G,HU YM,et al.A comparative analysis of immunogenicity and safety of an enterovirus 71 vaccine between children aged 3～5 years and infants aged 6～35 months[J]. Expert Review of Vaccines,2018,17(3):1234-1254.
[14] 王雷,王四全,胡樱,等. 湖北省2016—2017年肠道病毒71型灭活疫苗上市后安全性[J]. 中国疫苗和免疫,2018(4):471-474.