各类乙型肝炎疫苗的现场评价  

A Study of Immunogenicity of 4 Kinds of Hepatitis B Vaccines

作　　者：井立臣[1] 张宛[1] 张群弟[1] 李淑秋[1] 石桂荣[1] 胡宗汉 宋珍珠 吴小荫 李金荣[1] 王家威[1] 

机构地区：[1]中国医科大学流行病学教研室,中国生物制品检定所,沈阳市和平区卫生防疫站

出　　处：《中国医科大学学报》1996年第3期251-254,共4页Journal of China Medical University

基　　金：国家"七五"科技攻关项目;国家"八五"科技攻关项目

摘　　要：为评价新近研制出的哺乳动物细胞重组基因乙型肝炎疫苗（ＭＣＤＶｖ）和重组牛痘毒病毒乙型肝炎疫苗（ＲＶＤＶ）能否推广使用，以及为国产重组酵母乙型肝炎疫苗（ＹＤＶ）的发展提供方向，作者以国产注册使用的血源乙型肝炎疫苗（ＰＤＶ）为参照组，在健康青年学生中，采用随机、双盲、对照实验，评价了美国Ａｍ－ｇｅｎ苗（ＹＤＶ），比利时Ｓｍｉｔｈ苗（ＹＤＶ），日本Ｘ苗（ＹＤＶ），国产ＭＣＤＶ１和ＭＣＤＶ２（ＭＣＤＶ）苗及国产ＲＶＤＶ（ＲＶＤＶ）苗的免疫原性。结果表明，这７个疫苗均无严重副反应，安全可用；均能诱导机体产生保护水平的抗体（阳转率９３％～１００％）。但抗－ＨＢｓ几何平均滴度（ＧＭＴ）不同，以Ａｍｇｅｎ，Ｓｍｉｔｈ为最好，国产ＰＤＶ，ＲＶＤＶ次之，可推广使用；在发展重组酵母乙型肝炎疫苗的生产时，应考虑Ａｍｇｅｎ和Ｓｍｉｔｈ公司的先进生产技术与工艺。he immunogenicity of 4 kinds of hepatitis B vaccines was evaluated in this paper.They were:re-combinant veast-derived hepatitis B vaccine (YDV)which included Amgen(made in U.S.A.),Smith(made in Belgium)and X(made in Japan);plasma-derived hepatitis B vaccine(PDV)which was made inchina; recombinant mammalian cell-derived hepatitis B vaccine(MCDV)which included 2 bats of vac-cines made in China,MCDV1 (8910)and MCDV2(8912);and recombinant vaccinia virus-derived hepati-tis B vaccine(RvDV)which was made in China. The purpose was to determine if the RVDV and MCDVwhich were recently developed can be used in the population,as well as to provide the data for the devel-opment of the recombinant yeast-derived hepatitis B vaccine in our country. The results showed thatthese 7 vaccines were safe and could be used in the population;they could induce anti-HBs with protect-ed level(>10 mIU/ml)at seroconvertion rates of 93.0%to 100%, but the GMTs (Geometric MeanTitre) of Anti-HBs were different. Among them, the GMT of Amgen and Smith is the highest,the oneof pDV and RVDV was the second, and the one of MCDV and X was the third. We concluded that theimmunogenicity of our RVDV products was the same as our PDV products and they could be used in thepopulation;the immunogenicity of our hepatitis B vaccines was less than the one of hepatitis B vaccinesmade by the developed companies in the world. When we develope YDV,we should consider their ad-vanced technique and technology.

关 键 词：免疫原性 乙型肝炎疫苗 

分 类 号：R512.62[医药卫生—内科学]