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作者对150名甲型肝炎病毒抗体(抗-HAV)、抗-HBs、抗-HBc和HBsAg阴性的健康青年(男39人、女111人)进行了随机双盲研究.乙型肝炎疫苗系酵母重组HBsAg,甲型肝炎疫苗用HM175株病毒灭活制成.每剂(1ml)联合疫苗含HBsAg20μg,HAV抗原720ELISA单位(ELU),用0.45mg铝盐吸附,由Smithkline Beecham生物制品公司制备,按0、1和6月程序接种於上臂三角肌内.把150名青年分成3组接种3批疫苗.首针后1、2、6和7月采集血标本,用ELISA测抗-HAV,≥33mIU/ml为血清阳转;用放射免疫法测抗-HBs,≥1mIU/ml为阳转,≥10mIU/ml为保护水平.同时测转氨酶活性.共有147人完成研究.局部和全身反应发生率各组间没有显著差异,局部反应两倍
The authors conducted a randomized double-blind study of 150 Hepatitis A virus (anti-HAV), anti-HBs, anti-HBc and HBsAg-negative healthy youth (39 males and 111 females). Hepatitis B vaccine Recombinant HBsAg and Hepatitis A vaccine were inactivated by HM175 virus, and each dose (1ml) of combination vaccine contained 20μg HBsAg and 720ELISA HAV antigen unit (ELU), adsorbed by 0.45mg aluminum salt and prepared by Smithkline Beecham Bioproducts Co., 0, 1 and 6 months inoculation of the upper arm deltoid muscle 150 young people were divided into 3 groups were vaccinated three batches of vaccine.After the first needle 1,2,6 and 7 month blood samples were collected, measured by ELISA anti-HAV, ≥ 33mIU / ml for seroconversion; anti-HBs by radioimmunoassay, ≥1 mlU / ml as positive, ≥10 mlU / ml as protection level.At the same time, aminotransferase activity was measured.A total of 147 patients completed the study.The incidence of local and systemic reactions No significant difference between groups, local response twice