重组乙型肝炎疫苗(酵母)与乙肝免疫球蛋白联用阻断乙肝母婴传播研究  

Effect of recombinant hepatitis B vaccine(originated from Saccharomyces cerevisiae) combined with hepatitis B immunoglobulin on blocking HBV maternal-neonatal transmission

作　　者：潘红星[1] 曾滢 宋雪芳 张艺飓[1] 朱凤才[1] 

机构地区：[1]江苏省疾病预防控制中心,南京210009 [2]深圳康泰生物制品有限公司,深圳518057

出　　处：《江苏预防医学》2015年第6期1-4,共4页Jiangsu Journal of Preventive Medicine

基　　金：江苏省疾病预防控制中心科教兴业工程(JKRC2011007);教育部重点实验室开放课题资助项目(2010EME002)

摘　　要：目的了解国产10μg重组乙型肝炎疫苗(酵母)与乙肝免疫球蛋白(HBIG)联用实施母婴乙肝阻断效果,评价其免疫原性和安全性。方法按母亲乙肝"两对半"检测结果设阳性(双阳、单阳)、阴性组,各组设试验组、对照组,新生儿按一定比例随机进入各组。阳性组、阴性对照1组均按0、1、6月程序接种10μg疫苗,对照2组按同样程序接种5μg疫苗,阳性组均在接种首剂疫苗同时接种HBIG。采用系统观察、定期访视以及监护人主动报告等方法观察接种后不良反应;并于出生第7个月检测HBsAb浓度。结果国产10μg疫苗与HBIG联用阳性组新生儿母婴阻断保护率为98.21%,HBsAb阳转率、达正常应答水平比例、抗体几何均数浓度(GMC)分别为93.55%、87.58%、587.04IU/L,均与国外同类疫苗制品效果相当。阴性组中国产10μg肝疫苗全程接种后HBsAb阳转率、达正常应答水平比例、GMC分别为95.01%、92.22%、802.83IU/L,优于接种国产5μg疫苗。各组局部、全身不良反应均以1级为主,发生率均较低,且试验组与对照组差异均无统计学意义。结论国产10μg重组乙肝疫苗(酵母)与HBIG联用实施乙肝母婴阻断效果较好,其免疫原性和安全性良好。Objective To evaluate the protective effect of 10 μg recombinant hepatitis B vaccine （originated from Saccharomyces cerevisiae）combined with hepatitis B immunoglobulin（HBIG） on blocking H BV maternal-neonatal transmission; to evaluate its safety and immunogenicity. Method A randomized, double-blinded, controlled research was performed. Positive group （double/single positive） ,negative groups were set based on 5 HB serum antigen and antibody indicators of mothers; each group were divided into test group and control group; newborns were assigned to each group randomly according at certain ratios. Subjects in positive group and negative control group Ⅰ were inoculated with 3 doses of HB 10 μg recombinant HB vaccines at 0, 1 and 6 months after birth; subjects in negative control group Ⅱwere inoculated with 5 μg HB vaccines of the same manner; all subjects were inoculated with HBIG with the first dose of HB vaccine simultaneously. The adverse reactions were observed by systematic observation, follow-up study management and active report. Blood samples of newborns were obtained to assess serological HBsAb concentration at 7 months. Results Protective rate of 10μg recombinant HB vaccine made in China combined with HBIG was 98.21% ;sero-conversion rate, geometric mean concentration （GMCs） and normal response rate were 93.55%, 587. 04 mIU/ml and 87. 58% , respectively, which were equivalent with imported products. Seroeonversion rate, GMC and normal response rate were 95.01%, 802.83 mIU/ml and 92.22% ,respectively for subjects in negative group inoculated with 10 μg vaccines made in China ,which were better than the effects after inoculation of 5 μg vaccines. Local and systematic adverse reactions were rare and mainly were level I , no statistical difference was observed between adverse reaction rates of test group and negative group. Conclusion The combination of 10 μg reeombinant HB vaccine made in China and HBIG was effective on blocking HBV maternal-neonatal transmission, with high immunogen

关 键 词：乙型肝炎 重组乙型肝炎疫苗(酵母) 乙肝免疫球蛋白 母婴传播阻断 免疫原性 安全性 接种剂量 

分 类 号：R512.6[医药卫生—内科学]