摘要
目的评价国产甲型病毒性肝炎(甲肝)减毒活疫苗(Hepatitis A Attenuated Live Vaccine,HepA-L)和灭活疫苗(Hepatitis A Inactivated Vaccine,HepA-I)的安全性,为开展甲肝爆发疫情应急接种提供参考。方法用美国雅培(Abbott)公司生产的抗甲肝病毒抗体(Antibody to Hepatitis A Virus,Anti-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和国产HepA-I,以国产的重组乙型肝炎疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Technigues in Sacchararomyces Cerevisiae Yeast,HepB-SCY)为阴性对照,以GlaxoSmithKline 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30min和24、48、72h的不良反应发生率。结果各组不良反应主要表现为发热、接种部位疼痛、硬结等,未发现严重不良反应,总发生率分别为:国产HepA-L13.95%,国产HepA-I15.25%,进口HepA-I16.80%,HepB-SCY25.62%,各试验组不良反应发生率的差异无统计学意义(2=6.953,P=0.073)。结论国产HepA-L和国产HepA-I以及进口HepA-I安全性良好。
Objective To evaluate and hepatitis A inactivated vaccine hepatitis A outbreaks. Methods safety of domestic hepatitis A attenuated live vaccine （HepA-L） （HepA-I）, and provide reference for emergency vaccination after 493 children aged 6-9 years confirmed negative with antibody to hepatitis A virus （Anti-HAV） produced by Abbott. U.S were divided randomly into four groups. Group A were vaccinated with domestic HepA-L, group B were vaccinated with domestic HepA-I, group C were vaccinated with hepatitis B vaccine made by recombinant deoxyribonucleic acid technigues in sacchararomyces cerevisiae yeast （HepB-SCY）as negative control and group D were vaccinated HepA-I produced by GlaxoSmithKline Biologicals S.A. （GSK）as positive control. The adverse events following immunization （AEFIs） were observed after 30 minutes, 24, 48 and 72 hours after vaccination with double-blind method. Results The main AEFIs were fever, local pain and scleroma. There were no other severe AEFIs. The rate of AEFIs was 13.95% in Group A, 15.25%0 in group B, 16.80% in group C and 25.62% in group D. There were no statistical differences between different groups （x2=6.953, P=0.073）. Conclusion Domestic HepA-L, domestic HepA-I and imported HepA-I are Safe.
出处
《中国疫苗和免疫》
CAS
2012年第4期302-306,共5页
Chinese Journal of Vaccines and Immunization
基金
国家科学技术重大专项传染病及病媒生物控制适宜技术研究项目不同甲型肝炎疫苗免疫效果及应急适宜技术研究课题(编号:2008BAI56B00)
关键词
甲型肝炎减毒活疫苗
甲型肝炎灭活疫苗
安全性
Hepatitis A attenuated live vaccine
Hepatitis A inactivated vaccine
Safety
