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目的评价乙型肝炎(乙肝)病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]阳性母亲的儿童接种乙肝疫苗(Hepatitis B Vaccine,HepB)后的低/无应答者,采用重组HepB(中国仓鼠卵巢细胞)(HepBMade by Recombinant Deoxyribonucleic Acid Techniques in Chinese Hamster Ovary Cell,HepB-CHO)再免疫的血清学效果。方法选择2008～2009年出生的HBsAg阳性母亲的新生儿249例,出生时按0、1、6个月免疫程序接种10微克(g)重组HepB(汉逊酵母),免疫后6～12个月检测抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)、抗乙肝病毒核心抗原抗体(Antibody to HBV Core Antigen,Anti-HBc)。HBsAg、Anti-HBs均阴性者接种一剂20g重组HepB-CHO,免疫后1个月再检测Anti-HBs。结果基础免疫后儿童HBsAg阳性率0.40%;Anti-HBc阳性[Anti-HBc≥1毫国际单位/毫升(mIU/m1)]率12.05%:Anti-HBs阳性(Anti-HBs≥100mIU/ml)率71.49%,Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)为(543.29±2.96)mIU/ml。再免疫一剂20g重组HepB-CHO后,Anti-HBs阳性率为95.44%;免疫前Anti-HBs无/低应答者,免疫后Anti-HBs阳转率为82.54%,Anti-HBs GMC为(501.45±3.94)mIU/ml。无/低应答者的阳转率分别为60.00%、86.79%,差异无统计学意义(P<0.05);无/低应答者Anti-HBs GMC分别为(140.75±2.41)mIU/ml、(637.28±3.74)mIU/ml。结论对HBsAg阳性母亲的儿童接种HepB后的低/无应答者,采用20g重组HepB-CHO实施再免疫,血清学效果良好。
Objective To evaluate the efficacy and safety of recombinant HepB (Hepatitis B Vaccine) in children with Hepatitis B Virus (HBsAg) positive mothers who received hepatitis B vaccine (HepB) (HepBMade by Recombinant Deoxyribonucleic Acid Techniques in Chinese Hamster Ovary Cell, HepB-CHO). Methods A total of 249 newborns with HBsAg positive mothers born during 2008 ~ 2009 were enrolled. Ten micrograms (g) recombinant HepB (Hansenula polymorpha) was inoculated at 0, 1 and 6 months of age at birth. After 6 ~ 12 months Antibody to HBsAg (Anti-HBs) and Anti-HBV Core Antigen (Anti-HBc) were detected. HBsAg, Anti-HBs are negative were inoculated with a dose of 20g recombinant HepB-CHO, one month after the immunization of anti-HBs. Results The positive rate of HBsAg in children after basic immunization was 0.40%. Anti-HBc positive rate (Anti-HBc≥1 mIU / ml) was 12.05% 71.49%. The Geometric Mean Concentration (GMC) of Anti-HBs was (543.29 ± 2.96) mIU / ml. Anti-HBs positive rate was 95.44% after re-immunization with 20g recombinant HepB-CHO; Anti-HBs positive rate was 82.54% and Anti-HBs GMC was (501.45 ± 3.94) mIU / ml. The positive rates of anti-HBs GMC were (140.75 ± 2.41) mIU / ml and (637.28), respectively, with no / low responders were 60.00% and 86.79% respectively, with no significant difference ± 3.74) mIU / ml. Conclusion The seropositive effect of 20g recombinant HepB-CHO on re-immunization of children with HBsAg-positive mothers after vaccination with HepB was good.