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  

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

作　　者：时景璞[1] 李征远 郑力国 徐占民 王桂花 王昕[1] 张群弟[1] 杨志齐 孙宏章 郭乃全 梁争论[4] 吴晓音[4] 

机构地区：[1]中国医科大学第一临床医院临床流行病学教研室,沈阳110001 [2]辽宁省北票市中小学卫生保健所体检科 [3]北票矿务局总医院外科 [4]中国药品生物制品检定所疫苗二室

出　　处：《中华流行病学杂志》2001年第2期105-107,共3页Chinese Journal of Epidemiology

摘　　要：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 2 2～ 5 8岁的教师 ,随机抽取 12 4名 ,按 0、1、6个月程序 ,每剂 5 μg/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　免疫后 3、7、12个月时 ,抗 HBs阳转率分别为 35 .0 %、83.3%、6 7.2 % (P <0 .0 1)。抗 HBs平均滴度分别为 12 .6 3mIU/ml、40 2 .0 4mIU/ml、70 .2 8mIU/ml(P <0 .0 1) ;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岁组的抗体阳转率高于 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 μg/ 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.

关 键 词：重组酵母乙型肝炎疫苗 抗体阳转率 抗体几何平均滴度 乙型肝炎 安全性 

分 类 号：R186[医药卫生—流行病学]