以临床-实验室-临床模式研究抗原-抗体复合物型治疗性乙型肝炎疫苗  

Development of an antigen-antibody immune complex therapeutic hepatitis B vaccine in clinical-laboratory-clinical model

作　　者：汪萱怡[1,2] 闻玉梅[1] 

机构地区：[1]复旦大学上海医学院教育部/卫生部医学分子病毒学开放实验室,200032 [2]复旦大学生物医学研究院

出　　处：《传染病信息》2010年第4期193-195,226,共4页Infectious Disease Information

基　　金：国家"十一五"科技重大专项(2008ZX10002-003)

摘　　要：寻找新的治疗慢性乙型肝炎(乙肝)的途径,首先须要综合乙肝慢性化的机制。本研究选择以消除对乙肝病毒免疫耐受性为目标的治疗策略,通过对鸭乙肝病毒感染的幼鸭及乙肝表面抗原阳性的转基因小鼠的研究,发现注射特定比例的乙肝表面抗原-抗体复合物可在部分动物模型中逆转免疫耐受性。用此策略在获得国家食品药品监督管理局批准后,进行了Ⅰ、Ⅱ、Ⅲ期临床研究。本文报告了相应结果(Ⅲ期临床结果将于2010年底揭盲),并讨论了根据临床研究出现的问题进一步开展实验室研究的内容。It is necessary to do integrated study of the mechanisms involved in chronic hepatitis B virus （HBV） infection, prior to the development of novel therapeutic approaches. We have selected the therapeutic strategies with the abrogation of immune tolerance to HBV as the target in the patients with chronic hepatitis B. By the studies on ducklings infected with duck HBV and HBsAg positive transgenic mice, the injection of antigen-antibody complexes in certain proportions have shown to be effective in re- verting immune tolerance to HBV in parts of animal models. After being evaluated and approved by the State Food and Drug Administration, phase Ⅰ, Ⅱ/and Ⅲ clinical trials of yeast-derived I-IBsAg-HBIG complexes （YIC） have been carried out in the patients with chronic hepatitis B. This article reports the results of phase Ⅰand Ⅱ clinical trials, while results of phase Ⅲclinical trial will be available after breaking the code at the end of 2010, and discusses further experimental studies based on the questions arisen in clinical trials.

关 键 词：肝炎 乙型 慢性 抗原抗体复合物 临床试验 疫苗 

分 类 号：R512.62[医药卫生—内科学]