成人接种重组酵母乙型肝炎疫苗免疫效果观察  

Immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine in adults

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

机构地区：[1]中国医科大学第一临床医院临床流行病教研室,沈阳110001 [2]辽宁省北票市中小学卫生保健所体检科 [3]辽宁省北票市第二人民医院 [4]卫生部生物药物制品检定所疫苗二室

出　　处：《中华预防医学杂志》2002年第6期366-369,共4页Chinese Journal of Preventive Medicine

基　　金：国家"九五"攻关课题 (96 90 6 0 3 0 3 )

摘　　要：目的　探讨重组酵母乙型肝炎 (乙肝 )疫苗 (YDV)对成人的免疫效果及其安全性。方法　在辽宁省北票市部分学校随机选择一般健康状况良好、乙肝表面抗原 (HBsAg)、乙肝表面抗体 (抗 HBs)及乙肝核心抗体 (抗 HBc)三项指标均为阴性且体温正常的 2 2～ 5 8岁的教师 12 4名 ,按 0、1、6个月程序 ,每次 5 μg/ 0 5ml接种国产重组酵母乙肝疫苗。 结果　免疫后 3、7、12和 2 4个月时 ,抗 HBs阳转率分别为 35 0 %、83 3%、6 5 5 %和 32 7% ,抗 HBs平均滴度分别为 12 6、4 0 2 0、70 3和 2 0 3mIU/ml;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 ;免疫后各月女性抗 HBs阳转率和滴度均高于男性 ;<35岁组的抗体阳转率高于≥ 35岁组 ,但 12个月时二者比较差异有显著意义 ;免疫 3d后未出现局部和全身不良反应。结论　重组酵母乙肝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。Objective To study the immunogenicity and safety of recombinant yeast derived hepatitis B vaccine (YDV) in adults Methods One hundred and twenty four healthy teachers aged 22～58 years with serum negative HBsAg, anti HBs, anti HBc and with normal temperature were randomly selected from Beipiao city, Liaoning province. All the subjects were immunized with 5 μg/0 5 ml of YDV made by Beijing Institute of Biologic Products, for three doses at an interval of one and six months, respectively. Results The positivity of serum anti HBs was 35.0%,83.3%,65.5% and 32.7% with a geometric mean titre (GMT) of 12.6 mIU/ml, 402 .0 mIU/ml,70.3 mIU/ml and 20.3 mIU/ml, respectively, three, seven, 12 and 24 months after immunization. The positivity and GMT of serum anti HBs appeared the highest seven months after immunization, then began to decrease sharply. The positivity and GMT of serum anti HBs in women was higher than that in men either three, or seven, or 12, or 24 months after immunization. The positivity of serum anti HBs in those of 35 years or over was lower than that less than 35 years, seven months after immunization, but no age difference could be found 12 months after immunization. No local or systematic adverse reactions were found in all the subjects within three days after immunization Conclusion The recombinant yeast derived hepatitis B vaccine (YDV) is immunogenic and safe for adults, but the persistency of serum anti HBs in after immunization should be followed up further.

关 键 词：成人 接种 重组酵母乙型肝炎疫苗 免疫效果观察 

分 类 号：R186[医药卫生—流行病学]