【摘要】 本文报道乙型肝炎疫苗观察一年的现场试验。127例随机、双盲分为四组:第1,2,3组各接种1.0,0.5,0.25ml 疫苗,第4组接种1ml 安慰剂“疫苗”。各对象皮下接种3次,分别于1月,2月,6月各接种一次。接种疫苗后四组总的反应率各为93.3%,46.2%,50.0%与10.0%。原发反应率各为90.9%,41.7%,42.5%,5.3%,均以1ml 组反应最佳。抗-HBs 产生以1ml 组出现最早,维持期最长。65例以往无 HBV 感染史者,产生抗-HBs 滴度较低;46例以往已感染 HBV 者,在接种第1针后15天抗-HBs 明显上升,未见有明显副反应,唯接种局部出现短暂疼痛。本疫苗抗原性佳;但免疫原性尚不理想。更多还原

【Abstract】 One hundred twenty-seven subjects were randomly and double-blindly allocated into 4 groups;the first 3 groups were immunized with lml,0.5ml and 0.25mlvaccine,respectively.1ml placebo was given in the 4th group as control.Each subjectreceived 3 injections of vaccine subcutaneously at 1 mo,2 mo and 6 month-intervals.The response rates of the groups were 93.3%,46.2%,50.0% and 10.0%,aud theprimary responses were 90.9,41.7%,42.5% and 5.3%,respectively.The bestresponse was found in the 1ml group,in which the earliest appearance of anti-HBs antibodies was observed and the antibodies lasted the longest among the 4 groups.Anti-HBs response in 65 recipients without previous HBV infection showed low titers.Forty-six recipients who had been infected previously had an abrupt rise of anti-HBsin 15 days after 1st injection.No apparent side effect was observed except localsoreness.The vaccine has been proved efficacious with high antigenicity but withoutimmunogenicity.更多还原