重组（酵母）乙型肝炎疫苗免疫效果观察  

Efficacy study of yeast-derived recombinant hepatitis B vaccine

作　　者：吴维寿[1] 孙超美[1] 姜铭波[1] 张国华[1] 周宁[1] 张焕珠[1] 宿飞[1] 徐志一[2] 

机构地区：[1]上海市黄浦区疾病预防控制中心免疫预防科,200011 [2]国际疫苗研究所,韩国首尔

出　　处：《国际生物制品学杂志》2007年第4期145-147,共3页International Journal of Biologicals

摘　　要：目的观察重组（酵母）乙型肝炎（乙肝）疫苗在新生儿接种后的免疫效果，探究乙肝疫苗再免的需求。方法对上海市黄浦区1997年出生并接种合格乙肝疫苗的儿童，在免疫后1、3、5、7年采血随访观察，检测HBsAg、抗-HBs和抗-HBc，并开展急性肝炎流行病学监测。结果7年间，免疫人群HBsAg阳性率在1．5%上下波动，平均为1．47％（95％可信区间为0．61％～2．33%），与免疫前同一地区乙肝流行病学调查本底资料比较，乙肝疫苗保护效果为84．03％（95％可信区间78．92％～89．60％）。1997年接受乙肝疫苗免疫人群中，无急性乙肝发病。结论新生儿重组乙肝疫苗免疫后效果良好，目前无需考虑再免。Objective To evaluate immune efficacy of yeast-derived recombinant hepatitis B vaccine in newborns and the need for a booster dose. Methods Children who were born in Shanghai Huangpu District in 1997 and vaccinated with yeast-derived recombinant hepatitis B vaccine at birth were followed up every other year from 1997, and serum HBsAg, anti-HBs and anti-HBc were tested. Incidence of acute hepatitis was monitored. Results The positive rates of HBsAg in vaccinated children were about 1.5% with an average of 1.47 % （95% confidence intervals 0. 61%-2.33%）in seven years. Compared with the incidence of acute hepatitis B before vaccination in the same area,vaccine efficacy against hepatitis B was 84.03% （95% confidence intervals 78.92 %-89.60 %）. Acute hepatitis B was not found in children immunized with yeast-derived recombinant hepatitis B vaccine in 1997. Conclusions The recombinant hepatitis B vaccine has good immunogenicity and protective efficacy,and a booster close is not necessary currently.

关 键 词：乙型肝炎疫苗 肝炎表面抗原 乙型 接种 人群监测 

分 类 号：R51[医药卫生—内科学] R1[医药卫生—临床医学]