应用10μg酿酒酵母乙型肝炎疫苗免疫2~15岁儿童和青少年的抗体应答研究  

Study of the antibody response of 10μg hepatitis B vaccine in children of 2-15years old

作　　者：曾滢 宋雪芳 方鑫[2] 李彤 龙艳群 李杰[3] 朱凤才[4] 梁争论[2] 

机构地区：[1]深圳康泰生物制品股份有限公司,广东深圳518057 [2]中国食品药品检定研究院,北京100050 [3]北京大学医学部,北京10091 [4]江苏省疾病预防控制中心,江苏南京210009

出　　处：《中国病毒病杂志》2013年第6期420-422,共3页Chinese Journal of Viral Diseases

基　　金：国家"十二五"艾滋病和病毒性肝炎等重大传染病防治科技重大专项(2012ZX10002001)

摘　　要：目的评价10μg/剂重组乙型肝炎（乙肝）疫苗（酿酒酵母）接种2~15岁儿童和青少年人群的免疫原性。方法在江苏丹阳招募1 288名2~15岁健康儿童和青少年随机入选为试验组（649人）及对照组（639人）,按0,1,2月程序分别接种10μg和5μg剂型康泰公司生产的酵母乙肝疫苗。于第1针接种前及接种后1、2和3月时采集静脉血并分离血清,检测乙肝表面抗体（抗-HBs）指标,计算几何平均浓度（GMC）。结果全程免疫后1月时试验组人群抗-HBs水平显著高于对照组（1 375.0mIU/ml vs 854.69mIU/ml,P〈0.05）;而试验组与对照组抗-HBs阳转率均呈现较高水平（99.68%vs 99.00%,P〉0.05）。结论 10μg剂型酿酒酵母乙肝疫苗免疫儿童和青少年人群的抗体水平显著优于5μg剂型疫苗,适用于2~15岁青少年儿童的预防接种。Objective To assess the immunogenicity of HepBSC, a kind of recombinant hepatitis B vaccine from Saccharomyces cerevisiae at 10 μg/dose of hepatitis B virus （HBV） surface antigen （HBsAg） among children and adolescents of 2-15 years old. Methods A total of 1 288 subjects at the age of 2-15 years old were enrolled. Subjects were randomized to receive three doses of HepB-SC at either 10 μg/dose （n=649） or 5μg/ dose （n = 639） intramuscularly （Shenzhen Kangtai Biological Products CO., LTD） at the schedule of months 0, 1, 2. Blood samples were collected before vaccination and at the first month, second month, third month after the first dose of vaccination; sera were separated to detect the anti-HBs levels （GMC）, Results One month after three doses of immunization, the anti-HBs GMC level of the 10 μg/dose of HepB-SC was sig- nificantly higher than that of the 5 μg/dose （1375.0 mlU/ml vs 854.69 mlU/ml, P〈0.05） . The anti-HBs seroconversion rates in both groups were very high （99.68% vs 99.00%, P〉0.05）. Conclusions The anti- HBs GMCs of 10 μg/dose of HepB-SC group was significantly higher than that of the 5 μg/dose group in chil- dren and adolescents at 2-15 years old in China. The 10 μg/dose HepB-SC can be applied to the population younger than 16 years old.

关 键 词：肝炎 乙型 疫苗 抗体 

分 类 号：R725.7[医药卫生—儿科]