我国研制的乙型肝炎基因重组(CHO)疫苗对乙型肝炎病毒母婴传播阻断效果观察  

Study on Protective Efficacy of CHO Expressed Recombinant HBsAg Vaccine in Blocking Mother-Infant Transmission of Hepatitis B Virus

作　　者：孟宗达 韩秀兰[2] 林惠芳 杜敏[2] 侯通[2] 杨翠丽 董永辉[2] 赵玉良 刘洪斌 

机构地区：[1]河北省卫生防疫站,保定071000 [2]石家庄市卫生防疫站,河北石家庄050011 [3]石家庄市第六人民医院,河北石家庄050000

出　　处：《中国计划免疫》2001年第2期94-95,共2页Chinese Journal of Vaccines and Immunization

基　　金：国家"九五"科技攻关项目!( 96-90 60 3 )

摘　　要：为观察我国研制开发的乙型肝炎 (乙肝 )基因重组 (CHO)疫苗阻断乙肝病毒母婴传播的效果 ,选乙肝表面抗原 (HBsAg)、乙肝e抗原 (HBeAg)和乙肝核心抗体 (抗 -HBc) 3项均阳性的母亲所生婴儿 ,用乙肝CHO疫苗免疫 ,并随访观察 3年。婴儿随机分为A组 (5 2例 )和B组 (5 0例 ) ,A组为单纯疫苗组 ,注射 3次乙肝CHO疫苗 (0、1、6个月 ,10 μg/次 ) ;B组为疫苗加 5 0IU乙肝免疫球蛋白 (HBIG)组 ,同A组一样注射 3次乙肝CHO疫苗 ,但在 0月时同时注射HBIG(5 0IU)。全程免疫后 2～ 12个月、13～ 2 4个月、2 5～ 36个月分别采血 ,以固相放射免疫 (RIA)法检测乙肝表面抗体 (抗 -HBs)、HBsAg和抗 -HBc。综合 3次随访结果 ,单独及时全程接种乙肝CHO疫苗组 ,婴儿抗-HBs阳性率为 82 6 9% ,无应答率为 3 85 % ,HBsAg阳性率为 13 46 % ,保护率为 83 17% ;乙肝CHO疫苗加HBIG组 ,抗 -HBs阳性率为 90 0 0 % ,无应答率为 2 0 0 % ,HBsAg阳性率为 8 0 0 % ,保护率为 90 0 0 %。A、B两组的保护率虽不同 ,但差异无显著统计学意义 (χ2 =0 77,P =0 3788)。由此可见 ,乙肝CHO疫苗具有良好的安全性和免疫原性 ,可有效阻断乙肝病毒的母婴传播 ,出生时加注 5 0IUHBIG效果更好。This study was to investigate the preventive efficacy of CHO expressed recombinant HBsAg vaccine in blocking mother-infant transmission of hepatitis B virus. One hundred and two newborns born to HBsAg, HBeAg and anti-HBc positive mothers were randomly divided into two groups. Group A received full-dose HB vaccine at birth, 1 month and 6 months, 10μg/dose, and group B was the same as group A in receiving vaccine but additionally injected 50IU hepatitis B immune globulin(HBIG)at birth. Infants were collected blood 2～12 months, 13～24 months and 25～36 months after full-dose vaccination, and detected anti-HBs, HBsAg and anti-HBc by RIA method. The results were as follows: for the CHO vaccine group, after full-dose vaccination, the positive rate of anti-HBs was 82.69%, negative rate was 3.85%, HBsAg positive rate was 13.46%, protective rate was 83.17%; for the CHO vaccine group adding HBIG, the above 4 corresponding rates were 90.00%, 2.00%, 8.00% and 90.00% respectively, there had no difference with group A( χ 2=0.77, P =0.3788)statistically. The CHO expressed recombinant HBsAg vaccine showed good protective efficacy for infants born to HBV carrier mothers, if adding HBIG at birth, the efficacy would be better.

关 键 词：乙型肝炎 基因重组 母婴传播 保护效果 CHO疫苗 

分 类 号：R512.62[医药卫生—内科学] R186[医药卫生—临床医学]