不同剂量重组酵母乙型肝炎疫苗成人免疫效果对比  

Comparison of the immunogenicity of different doses of recombinant yeast-derived hepatitis B vaccine (YDV) on adults

作　　者：郑新华 袁跃彬[2] 沙岩 龚富山 李红亚 张好莲 卫玮 马西平 张根宏[4] 王仲倩[2] 

机构地区：[1]河南省平顶山市卫生学校,中国河南平顶山467000 [2]解放军152医院 [3]平顶山市卫生防疫站 [4]河南省卫生防疫站

出　　处：《实用预防医学》2002年第6期647-649,共3页Practical Preventive Medicine

摘　　要：目的　对比不同剂量重组酵母乙型肝炎疫苗的免疫效果。　方法　选择 2 0 0名一般健康状况良好、乙肝标志物阴性、谷丙转氨酶正常的 2 0～ 60岁学校工作人员随机被分为 A、B、C、D四组 ,四组的免疫程序同为 0、1、6个月 ,免疫剂量分别为 3针 5 μg、3针 10 μg、3针 15 μg、3针 2 0 μg重组酵母乙型肝炎疫苗。　结果　全程免疫后 1个月时四组抗 - HBs阳转率分别是 75 .0 0 %、91.84%、95 .65 %、97.87% ,四组间差别有显著性 (P<0 .0 1) ;四组抗 - HBs平均滴度 (GMT)分别是 197.4、3 15 .6、40 3 .6和 477.8m IU/ ml,四组间差别有显著性 (P<0 .0 1)。年龄、性别对免疫效果有影响。随着免疫剂量的增加 ,不良反应率随之增加 ,2 0μg组注射部位疼痛发生率为 7.5 9% ,5μg组注射部位疼痛发生率为 2 .0 3 % ,差别有显著性 (P<0 .0 5 )。　结论　我国健康成人应用重组酵母乙型肝炎疫苗免疫 ,同按 0、1、6个月免疫程序 ,3针 2 0 μg优于 3针10 μg,3针 10 μg优于 3针 5 μg。　建议　应用重组酵母乙型肝炎疫苗免疫 ,健康成人的免疫剂量是 3针 10 μg;3 5岁以上乙肝高危男性的免疫剂量是 3针 2 0Objective To compare the immunogenicity and safety of different doses of recombinant yeast-derived hepatitis B vaccine (YDV) on adults. Methods Two hundred healthy teachers of 20-60 years old were randomly divided into four groups of A, B, C, D. Their HBsAg, anti-HBs and anti-HBc were negative and their liver function was normal. The four groups (A, B, C, D) were vaccinated with 5 micrograms, 10 micrograms, 15 micrograms, 20 micrograms YDV respectively, all at 0, 1, 6 months. Result At seventh month the four groups' seroprection rates (SPR) were 75.00%, 91.84%, 95.65%, 97.87% respectively. There was significant difference among the four groups. The four groups' geometric mean titers (GMTs) were 197.4 mIU/ml, 315.6 mIU/ml, 403.6 mIU/ml, 477.8 mIU/ml respectively, the difference was also significant. Age and sex had effect on immunogenicity. It indicated that the more dosages, the higher rates of side reaction, the rates of injection site pain were significantly different between group A (2.03%) and group B (7.59%), P<0.05. Conclusion The immunogenicity of vaccination with 20 micrograms of YDV is higher than with 10 micrograms of vaccination, The immunogenicity of vaccination with 10 micrograms of YDV is higher than with 5 micrograms of vaccination.

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 免疫剂量 乙型肝炎 

分 类 号：R512.62[医药卫生—内科学]