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目的比较新生儿5微克(μg)重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Madeby Recombinant Dexyribonucleic Acid(DNA)Techniquesin Saccharomyces Cererisiae Yeast,HepB-SCY)初次免疫(初免)低应答者,使用不同种类、剂量和剂次HepB再免疫的血清学效果。方法将HepB-SCY初免后低应答的[10毫国际单位/毫升(m IU/ml)<抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)<100m IU/ml]7～12个月龄儿童随机分为2组,按照0、1、6个月免疫程序,分别用5μg HepB-SCY和10μg重组HepB-汉逊酵母(HepB Made by Recombinant DNA Techniguesin Hansenula Polymorpha Yeast,HPY)进行再免疫,于再免疫1剂和3剂后1个月采集血标本,比较不同种类、剂量和剂次HepB再免疫后的血清Anti-HBs应答情况。结果 5μg HepB-SCY组和10μg HepB-HPY组1剂再免疫后,Anti-HBs阳转(≥100m IU/ml)率分别为91.81%(258/281)和94.32%(249/264),差异无统计学意义(Χ2=1.31,P=0.25);3剂再免疫后,Anti-HBs阳转率分别为93.72%(209/223)和98.54%(203/206),差异有统计学意义(Χ2=6.53,P=0.01);10μg HepB-HPY组3剂再免疫Anti-HBs阳转率高于1剂,差异有统计学意义(Χ2=5.60,P=0.02)。5μg HepB-SCY组和10μg HepB-HPY组1剂再免疫后,Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为581.85m IU/ml[95%可信区间(Confidence Internal,CI)505.13m IU/ml～670.19m IU/ml]和1099.77m IU/ml(95%CI935.19m IU/ml～1293.90m IU/ml);3剂再免疫后,分别为522.22m IU/ml(95%CI452.79m IU/ml～602.98mIU/ml)和1218.33m IU/ml(95%CI1046.89m IU/ml～1417.15m IU/ml);1剂和3剂再免疫10μg HepB-HPY组Anti-HBsGMC均高于5μg HepB-SCY组(U值分别为34.09和64.06,P值均为0.00)。初免后Anti-HBs为10～49m IU/ml儿童,1剂和3剂再免疫后,Anti-HBs阳转率均低于初免Anti-HBs 50～99mIU/ml者,差异均有统计学意义(Χ2分别为21.81和6.62,P值分别为0.00和0.01)。结论 5μg HepB-SCY初免低应答儿童使用HepB再免疫1剂后,>90%可出现Anti-HBs阳转,使用10μg HepB-HPY再免疫后Anti-HBsGMC较高;再免疫阳转率与初免抗体水平有关。
Objective To compare the effect of primary immunization (initial immunization) of 5 micrograms (μg) of recombinant hepatitis B vaccine (Hepatitis B Vaccine Madeby Recombinant Dexyribonucleic Acid (DNA) Techniquesin Saccharomyces Cererisiae Yeast, HepB-SCY) , Serological effects of re-immunization with different kinds, doses and doses of HepB. Methods Low-response [10 mIU / ml (Antibody to Hepatitis B Virus Surface Antigen, Anti-HBs) <100 mIU / ml] after HepB- Children of 7-12 months old were randomly divided into two groups. According to the immunization schedule of 0, 1 and 6 months, 5μg HepB-SCY and 10μg recombinant HepB-Hansenula Polymorpha Yeast (HPY ) Were re-immunized. The blood samples were collected one month after re-immunization of one and three doses of anti-HBs. The serum anti-HBs responses of different types, doses and doses of HepB were compared. Results The rates of anti-HBs positive (≥100m IU / ml) were 91.81% (258/281) and 94.32% (249/264) respectively after immunization with 5μg HepB-SCY and 10μg HepB-HPY. The positive rates of anti-HBs were 93.72% (209/223) and 98.54% (203/206) respectively after 3 doses of re-immunization, with statistical significance (Χ2 = 1.31, P = 0.25) X2 = 6.53, P = 0.01). The positive rate of anti-HBs immunostimulated by 3 doses of 10μg HepB-HPY was higher than that of 1 dose (χ2 = 5.60, P = 0.02). The Geometric Mean Concentration (GMC) of Anti-HBs after re-immunization with 5μg HepB-SCY and 10μg HepB-HPY was 581.85m IU / ml [95% confidence interval (CI) 505.13 (95% CI 935.19m IU / ml to 1293.90m IU / ml) after 3 doses of re-immunization, respectively; 522.22m IU / ml (95% CI 935.19m IU / CI452.79m IU / ml to 602.98mIU / ml) and 1218.33m IU / ml (95% CI 1046.89m IU / ml to 1417.15m IU / ml); one and three doses of anti-HBsGMC Were higher than 5μg HepB-SCY group (U values were 34.09 and 64.06, P values were 0.00). The anti-HBs positive rate of Anti-HBs was lower than 50-99mIU / ml of Anti-HBs naive anti-HBs after immunization with anti-HBs of 10-49m IU / ml Significance (Χ2 = 21.81 and 6.62, P = 0.00 and 0.01 respectively). Conclusion Anti-HBs positive anti-HBs can be found in more than 90% of HepB-SCY naive children with HepB-HPY re-immunization after one immunization with HepB-HPY. Anti-HBsGMC is higher after re-immunization with 10μg HepB-HPY. Antibody-free level.