国产重组酵母乙型肝炎疫苗人体免疫效果观察  

Safety and immunogenicity of yeast recombinant hepatitis B vaccines(YRV) in clinical trials

作　　者：梁争论[1,2,3,4,5,6] 李艳萍[1,2,3,4,5,6] 赵桂珍[1,2,3,4,5,6] 荆庆 时景璞[1,2,3,4,5,6] 杨超美[1,2,3,4,5,6] 尹爱红 吴小音[1,2,3,4,5,6] 李成明 张华远[1,2,3,4,5,6] 李河民 

机构地区：[1]中国药品生物制品检定所 [2]广西壮族自治区卫生防疫站 [3]中国医科大学 [4]开封市卫生防疫站 [5]四川省卫生防疫站 [6]山东省卫生防疫站

出　　处：《中华微生物学和免疫学杂志》1999年第1期22-24,共3页Chinese Journal of Microbiology and Immunology

基　　金：国家"九五"科技攻关项目基金

摘　　要：目的我国重组酵母乙肝疫苗于１９９５年开始生产，目前对国产重组酵母乙肝疫苗的母婴传播阻断保护率和抗体应答水平尚不完全清楚。本次研究目的为评价国产重组酵母疫苗的安全性和免疫效果。方法应用３批国产重组酵母乙肝疫苗（卫生部北京生物制品研究所生产）。１批Ｍｅｒ－ｃｋ和１批Ａｍｇｅｎ进口重组酵母乙肝疫苗，对１８９名ＨＢｓＡｇ、ＨＢｅＡｇ双阳性母亲所生的新生儿进行了１年母婴传播阻断研究；同时对３６３名小学生进行了１年的免疫效果观察。免疫程序均为０，１，６月３针免疫。结果所有接种的新生儿和小学生中未发现严重副反应者。国产重组酵母疫苗母婴传播阻断保护率为８５．９７％，达到进口Ｍｅｒｃｋ（９０．３３％）和Ａｍｇｅｎ（８６．５９％）重组酵母疫苗的保护率水平。小学生完成３针免疫后１月（Ｔ７）时，接种各疫苗组的抗体阳转率均达９０％以上。Objective The yeast recombinant hepatitis B vaccine has overcome these limitations and proven safe and effective. Since 1995, a yeast recombinant hepatitis B vaccine produced in National Vaccine and Serum Institute has been put into use in China, while the protective efficacy(PE) of perinatal transmission and anti HBs response are still not clear. The aim of this study is to evaluate the safety and immunogenicity of the yeast recombinant hepatitis B vaccine. Methods 189 infants born to hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) positive mothers and 373 children aged 6 to 12 years were vaccinated with YRV ( 3 batches from National Vaccine and Serum Institute, 5μg/dose; 1 batch from Amgen, 10μg/dose; 1 batch from Merck, 5μg/dose) by 0, 1, 6 month schedule. Results No serious side reactions were found. The result of one year followed up showed that the PE of vaccines of National Vaccine and Serum Institute was similar to those of Merck and Amgen. The anti HBs positive conversion rates were above 90% after three doses for all 5 groups. It was demonstrated also that the PE of vaccines were not correlated with the geometric mean titres (GMT) of anti HBs. Conclusions This initial results revealed the safety and high PE of Beijing YRV.

关 键 词：乙型肝炎疫苗 重组疫苗 保护率 抗体特异性 

分 类 号：R512.620.3[医药卫生—内科学]