【摘要】 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。更多还原

【Abstract】 Objective To evaluate the effect of revaccination with recombinant hepatitis B vaccine derived from yeast among low-response infants after primary vaccination with 3 doses of 5μg hepatitis B vaccine made by recombinant dexyribonucleic acid ( DNA ) techniques in saccharomyces cererisiae yeast ( HepB-SCY ) .Methods The infants who were low-response to primary immunization with 3 doses of 5μg HepB-SCY were divided into two groups randomly,both of them were revaccinated on 0-1-6 schedule,but one group were vaccinated with 5μg HepB-SCY and the other with 10μg HepB made by recombinant DNA technigues in hansenula polymorpha Yeast ( HPY ) .Blood samples were collected one month after the first and the third dose.The conversion rate,that means the proportion of the subjects whose antibody to hepatitis B virus surface antigen Anti-HBs increase to 100mIU/ml or higher after revaccination,and the level of Anti-HBs were compared between the two groups.Results After the first dose of revaccination,Anti-HBs conversion rates were 91.81 %( 258/281 ) and 94.32 %( 249/264 ) in 5μg HepB-SCY group and 10μg HepB-HPY group respectively and no significant difference was found between the two groups (Χ2=1.31,P=0.25 ) .After the third dose of revaccination,the corresponding figures were 93.72 %( 209/223 ) and 98.54 %( 203/206 ) and significantly higher conversion rate was found in 10μg HepB-HPY group (Χ2=6.53,P=0.01 ) .The conversion rate after the third dose was statistically higher than the rate after the first dose in 10μg HepB-HPY group (Χ2=5.60,P=0.02 ) .After the first dose,the geometric mean concentrations ( GMC ) of Anti-HBs were 581.85mIU/ml [ 95 % confidence internal (CI) 505.13mIU/ml-670.19mIU/ml ] and 1099.77mIU/ml ( 95 %CI 935.19 mIU/ml-1293.90 mIU/ml ) in 5μg HepB-SCY group and 10μg HepB-HPY group respectively.After the third dose,the corresponding GMCs were 522.22mIU/ml ( 95 %CI 452.79mIU/ml-602.98mIU/ml ) and 1218.33mIU/ml ( 95 %CI 1046.89 mIU/ml-1417.15 mIU/ml ) .Anti-HBs level was statistically higher in 10μg HepB-HPY group than in 5μg HepB-HPY group both after the first and the third dose revaccination (U=34.09 and U=64.06 respectively,P< 0.01 ) .The conversion rate after the first dose of revaccination was significantly higher among the infants whose Anti-HBs ≥ 50mIU/ml after primary immunization than those whose Anti-HBs < 50mIU/ml after primary immunization (Χ2=21.81,P=0.00 ) .The difference was also significant after the third dose of revaccination (Χ2=6.62,P=0.01 ) .Conclusion More than 90 % low-response infants could achieved Anti-HBs conversion after one-dose of revaccination.Higher GMC could be got by revaccinating with 10μg HepB-HPY compared with 5μg HepB-SCY.The conversion rate after revaccination was related with Anti-HBs level after primary immunization.更多还原