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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。
This article reports a one-year field trial of Hepatitis B vaccine. One hundred and twenty-seven patients were randomized and double-blindly divided into four groups: Groups 1, 2 and 3 were vaccinated with 1.0, 0.5 and 0.25 ml of vaccine, and group 4 with 1 ml of placebo vaccine. Each subject was subcutaneously inoculated three times and inoculated once in January, February and June respectively. The total response rates of the four groups after vaccination were 93.3%, 46.2%, 50.0% and 10.0%, respectively. The primary reaction rates were 90.9%, 41.7%, 42.5% and 5.3%, respectively. Anti-HBs production in 1ml group appeared the earliest, the longest maintenance. In the past 65 cases, there was a low anti-HBs titer. In the 46 cases infected with HBV, the anti-HBs significantly increased on the 15th day after inoculation of the first needle, and no obvious side-effect was observed. Only the local inoculation Short-term pain. The vaccine antigen is good; but the immunogenicity is not ideal.