国产重组酵母乙肝疫苗对成人的免疫效果  

Evaluation of immunogenicity of yeast-derived recombinant hepatitis B vaccine in adults

作　　者：苏红丽[1] 封秀红[2] 张玉华 董春民[4] 郭韶红[4] 王文庆[4] 迮文远[4] 

机构地区：[1]河南省人民医院药剂科,郑州450003 [2]河南省卫生防疫站,郑州450003 [3]濮阳市卫生防疫站,濮阳457000 [4]卫生部北京生物制品研究所,北京100024

出　　处：《中国新药杂志》2004年第7期645-647,共3页Chinese Journal of New Drugs

摘　　要：目的:了解国产重组酵母乙肝疫苗(YDV)5μg和10μg对成人的安全性和免疫学效果。方法:199例研究对象随机分为2组,分别接受YDV 5μg和10μg,每人每月肌内注射1次,共3次(全程免疫)后1个月,进行免疫效果观察。检测血清乙肝表面抗体阳转率和乙肝表面抗体平均几何滴度(GMT),并观察2组的不良反应。结果:研究对象中未发现中、重度的局部和全身不良反应。接种5μg和10μg疫苗组的乙肝表面抗体阳转率分别为89.25％及98.11％;乙肝表面抗体GMT分别为18.88及54.47mIU·mL-1,2组的GMT差异有显著性(P<0.05)。结论:YDV成人免疫是安全的,10μg YDV抗乙肝表面抗体的GMT明显高于5μg YDV。Objective:To study the safety and immune efficacy of domestic yeast-derived recom-binant hepatitis B vaccine (YDV) in adults. Methods: 199 adults were randomly divided to receive 5 μg or 10μg YDV and the immune effects including the positive inversion rate of serum anti-HBs and the geometric mean titer (GMT) of anti-HBs and adverse events were observed. Results:The positive inversion rate of serum anti-HBs obtained was 89.25% for 5μg group and 98.11% for 10μg group.The GMT of anti-HBs obtained was 18. 88mIU· mL-1 for 5 μg group and 54.47mIU· mL-1 for 10μg group and there was significant difference between groups (P < 0.05). Conclusion: Domestic YDV is safe for immunization of adults and the GMT of anti-HBs in dose of 10μg is significantly higher than that in dose of the 5 μg.

关 键 词：国产重组酵母乙肝疫苗 免疫效果 乙肝表面抗体 平均几何滴度 

分 类 号：R969.4[医药卫生—药理学] R457.2[医药卫生—药学]