中国甲型肝炎减毒活疫苗和灭活疫苗免疫效果与安全性评价

李慧; 张晓曙; 安婧

Abstract

李慧,张晓曙,安婧.中国甲型肝炎减毒活疫苗和灭活疫苗免疫效果与安全性评价[J].Chinese journal of Epidemiology,2013,34(1):24-27

中国甲型肝炎减毒活疫苗和灭活疫苗免疫效果与安全性评价

Evaluation on the effect of immunization and safety of live attenuated and inactivated hepatitis A vaccine in China

Received:July 16, 2012

DOI：10.3760/cma.j.issn.0254-6450.2013.01.006

KeyWord: 甲型肝炎疫苗安全性免疫原性

English Key Word: Hepatitis A vaccine Safety Immunogenicity

FundProject:国家科技重大专项(2008BAI56800)

Author Name	Affiliation	E-mail
Li Hui	Gansu Provincial Center for Disease Control and Prevention, lanzhou 730000. China	lihui9208@163.com
Zhang Xiao-shu	Gansu Provincial Center for Disease Control and Prevention, lanzhou 730000. China
An Jing	Gansu Provincial Center for Disease Control and Prevention, lanzhou 730000. China

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Abstract:

目的评价中国甲型肝炎(甲肝)减毒活疫苗(HepA-L )和甲肝灭活疫苗(HepA-I )的安全性及免疫效果，为甲肝暴发疫情疫苗应急接种提供参考依据。方法用美国雅培(Abbott)公司生产的抗甲肝病毒抗体(抗一HAV)试剂筛查未感染HAV的6~9岁儿童。将人选对象随机分为4组，分别接种国产HepA-L和HepA-I，以国产重组乙肝疫苗(酿酒酵母)( HepB-SCY)为阴性对照，G1axoSmithKline Biologicals S.A.(GSK)生产的HepA-I为阳性对照，采取随机双盲方法观察接种疫苗后30 min及24,48,72 h的不良反应发生率。采用美国Abbott Laboratories生产的HAVAB 2.0试剂，利用微粒子酶免疫分析与电化学发光免疫测定法(MEIA)检测1,2,4周以及12个月的HAV IgG抗体水平。结果各组未发现严重不良反应，不良反应主要表现为发热、接种部位疼痛、硬结等。国产HepA-L和HepA-I组不良反应发生率分别为13.95%和15.25%，阳性对照组为16.80%，阴性对照组为25.62%，各组间差异无统计学意义。接种2周后，国产HepA-L和HepA-I抗体阳转率分别为85.00%和94.59%;接种后第4周，抗体阳转率达到100%;接种2,4.12周时试验组、阳性对照组HAV IgG抗体水平高于阴性对照组;接种12个月后，国产HepA-I组甲肝抗体水平高于阳性对照组。结论国产HepA-L和HepA-I以及进口HepA-I安全性良好，均具有较好的免疫效果。

English Abstract:

Objective To evaluate the safety of both domestic live attenuated and inactivated hepatitis A vaccines, and to provide reference for emergent vaccination after hepatitis A outbreaks.Methods 493 children aged 6-9 with negative antibodty to HAV (produced by Abbott) were randomly divided into four groups as vaccinated with domestic live attenuated hepatitis A vaccine(Group A)，domestic inactivated hepatitis A vaccine ( Group B )，imported inactivated hepatitis Avaccine ( Group C ) and hepatitis B vaccine ( Group D ) respectively. Adverse events following the immunization were observed 30 minutes, 24, 48 and 72 hours after the vaccination, under doubleblind method. Results The main AEFIs were: fever, local pain and scleroma but no other severe AEFIs were obvserved. The rates of AEFIs were 13.95% in Group A,15.25% in group B, 16.80% in group C and 25.62% in group D,with no statistical differences between these groups (x²=6.953,P> 0.05 ). 2 weeks after the vaccination, the positive conversion rates of domestic live attenuated hepatitis A vaccine and domestic inactivated hepatitis A vaccine were 85.00% and 94.59% respectively. Therate of domestic inactivated hepatitis A vaccine reached 100% at 4 weeks after the vaccination. The antibody levels of HAV IgG of Group A and B in 2, 4 and 12 weeks of vaccination and of Group Cwere higher than that of Group D. After 12 weeks of vaccination, the antibody level of group B became higher than it was Group C. Conclusion There were no differences on safety among domestic live attenuated hepatitis A vaccine, domestic inactivated hepatitis A vaccine or importedinactivated hepatitis A vaccine under routine or emergency vaccination. All the vaccines showedsatisfactory effects.

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