摘要
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-HAV）试剂筛查未感染HAV的6～9岁儿童。将入选对象随机分为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，GlaxoSmithKlineBiologicalsS．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扁30min及24、48、72h的不良反应发生率。采用美国AbbottLaboratories生产的HAVAB2．0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LlHepA—I安全性良好，均具有较好的免疫效果。
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 antibody 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 A vaccine （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 double- blind 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 （x^2=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. The rate 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 C were 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 imported inactivated hepatitis A vaccine under routine or emergency vaccination. All the vaccines showed satisfactory effects.
出处
《中华流行病学杂志》
CAS
CSCD
北大核心
2013年第1期24-27,共4页
Chinese Journal of Epidemiology
基金
基金项目：国家科技重大专项（2008BAl56800）
