重组酵母乙型肝炎疫苗对成人的免疫效果及安全性的研究

目的：探讨重组酵母乙型肝炎疫苗（YDV）对成人的免疫效果及安全性。方法：在辽宁省北票市部分学校选择一般健康状况良好，乙型肝炎表面抗原（HBsAg）、乙型肝炎表面抗体（抗－HBs）、乙型肝炎核心抗体（抗－HBc）三项指标均为阴性，体温正常的22－58岁的教师，随机抽取124名，按0、1、6个月程序，每剂5μg／0.5ml接种卫生部北京生物制品研究所生产的重组酵母乙型肝炎疫苗。结果：免疫3、7、12个月时，抗－HBs阳转率分别为35.0％、83.3％、67.2％（P＜0.01）。抗－HBs平均滴度分别为12.63mIU/ml；402.04mIU/ml、70.28mIU/ml(P＜0.01）；抗－HBs阳转率及其滴度均在7个月时达到高峰，以后又急剧下降。免疫后3、7、12个月时，女性抗－HBs阳转率和滴度均高于男性。但仅抗－HBs滴度在免疫后3个月时两者之间差异有显著性；小于35岁的抗体阳转率高于35岁以上组，但仅在免疫后12个月时两者之间差异有显著性；而该两个年龄组间的抗－HBs滴度差异无显著性；免疫3d后局部和全身未见不良反应。结论：重组酵母乙型肝炎疫苗对成人具有良好的免疫原性和安全性，其抗－HBs持续时间有待进一步观察。

Immunogenicity and safety of recombinant yeast -derived hepatitis B vaccine( YDV)on adults

OBJECTIVE: To study the immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine (YDV) on adults. METHODS: One hundred twenty-four healthy teachers of 22 - 58 years old, were randomly selected in Beipiao city, Liaoning province. Their HBsAg, anti-HBs and anti-HBc were all negative and temperature was normal. They were vaccinated with 5 microgram/0.5 ml of YDV, which was made in Beijing Institute of Biologic Products, at 0, 1, 6 months. RESULTS: The positive rates of anti-HBs were 35.0%, 83.3%, 67.2% (P < 0.01) with the mean geometric titre (GMT) of anti-HBs 12.63 mIU/ml, 402.04 mIU/ml and 70.28 mIU/ml (P < 0.01) at 3th, 7th, 12th months respectively. The positive rates of anti-HBs and GMT of anti-HBs became the highest at 7th month, then began to decrease sharply. At 3th, 7th, 12th months the positive rates of anti-HBs and GMT of anti-HBs were higher on female compared to male, but only GMT of anti-HBs was significantly different at 3th month; the positive rates of anti-HBs in below 35 years old group was higher than 35 and over years old group, but it was significantly different only at 12th month. GMT of anti-HBs between the two groups was no obvious difference. Local or systematic addictive reactions were not found in all the subjects in 3 days after injection. CONCLUSION: YDV is effective and safety to adults. The duration of anti-HBs should be further observed.