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目的了解乙型肝炎(乙肝)病毒表面抗原(Hepatitis B Virus Surface Antigen,HBsAg)阴性母亲所生儿童,按0、1、6月龄免疫程序初次免疫5微克(μg)重组乙肝疫苗(酵母)(Hepatitis B Vaccine Madeby Recombinant Deoxyribonucleic Acid Techniquesin Yeast,HepB-Y)3剂后,抗乙肝病毒表面抗原抗体(Antibodyto HBsAg,Anti-HBs)低/无应答发生情况,并比较不同剂量HepB-Y(5μg或10μg)再免疫1剂后Anti-HBs水平和阳转率。方法选择北京市、浙江省宁波市、广东省2004～2005年HBsAg阴性母亲所生儿童,按0、1、6月龄免疫程序初次免疫5μgHepB-Y3剂1～6个月后采集静脉血,用固相放射免疫法(Solid Phase Radioimmunoassay,SPRIA)进行血清学检测,对Anti-HBs低/无应答儿童再免疫1剂5μg或10μgHepB-Y,1个月后采集静脉血,用SPRIA法检测HBsAg、Anti-HBs、抗乙肝病毒核心抗原抗体(Antibody to HBV Core Antigen,Anti-HBC)。结果HBsAg阴性母亲所生新生儿按0、1、6月龄免疫程序初次免疫5μgHepB-Y3剂后,Anti-HBs低/无应答率分别为14.47%和1.71%;再免疫1剂5μg或10μgHepB-Y后,Anti-HBs平均浓度(Mean Concentration,MC)从25.50毫国际单位/毫升(mIU/ml)分别升高到143.04mIU/ml和167.52mIU/ml,抗体阳转率分别为80.00%和82.86%。再免疫后Anti-HBs MC的升高有统计学意义(t=-7.55,t=-7.06;P均<0.0001),但不同剂量再免疫后,Anti-HBs MC差异和抗体阳转率差异均无统计学意义(t=-0.59,P=0.53;χ2=0.11,P=0.74)。结论对于HBsAg阴性母亲所生的儿童,按0、1、6月龄免疫程序初次免疫5μgHepB-Y3剂后,Anti-HBs低/无应答率分别为14.47%和1.71%,再免疫1剂HepB-Y后抗体应答效果较好,且再免疫5μgHepB-Y能取得同再免疫10μgHepB-Y相同的效果。
Objective To know the children born to Hepatitis B Virus Surface Antigen (HBsAg) negative mothers and to immunize 5 μg recombinant hepatitis B vaccine (yeast) at 0, 1, 6 months of age Hepatitis B Vaccine Madeby Recombinant Deoxyribonucleic Acid Techniquesin Yeast, HepB-Y), anti-HBsAg (Anti-HBsAg, Anti-HBs) low / no response occurred and compared different doses of HepB-Y ) Anti-HBs level and positive conversion rate after a second immunization. Methods Children born in HBsAg-negative mothers from 2004 to 2005 in Beijing, Ningbo, Zhejiang Province and Guangdong Province were enrolled. Blood samples were collected from 1 to 6 months after immunization with 5 μg of HepB-Y3 for 0, 1, and 6 months of age. Serum tests were performed by solid phase radioimmunoassay (SPRIA). One dose of 5μg or 10μg HepB-Y was re-immunized with anti-HBs in children with low / no response. Venous blood was collected one month later. HBsAg was detected by SPRIA. Anti-HBs, Antibody to HBV Core Antigen (Anti-HBC). Results The low / non-response rate of Anti-HBs was 14.47% and 1.71% respectively after immunized with 5μg HepB-Y3 for 0, 1, 6 months old immunization program. The immunization with 5μg or 10μg HepB- Anti-HBs increased from 25.50 mIU / ml (mIU / ml) to 143.04 mIU / ml and 167.52 mIU / ml respectively, and the antibody positive conversion rates were 80.00% and 82.86 %. Anti-HBs MC after re-immunization increased statistically significant (t = -7.55, t = -7.06; P all <0.0001), but different doses of re-immunization, anti-HBs MC differences and antibody positive rate difference No statistical significance (t = -0.59, P = 0.53; χ2 = 0.11, P = 0.74). Conclusions For children born to HBsAg-negative mothers, the low / non-response rate of Anti-HBs was 14.47% and 1.71% respectively after immunized with 5μg HepB-Y3 for 0, 1, 6 months of age. After Y antibody response is better, and re-immunization 5μgHepB-Y can achieve the same effect with re-immune 10μgHepB-Y.