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目的评价新生儿接种乙型肝炎(乙肝)疫苗(Hepatitis B Vaccine,HepB)后,低/无应答者再免疫的抗体应答。方法选择新生儿按0、1、6个月免疫程序接种3剂5微克(μg)重组HepB(酿酒酵母)[HepB Made by Recombinant Deoxyribonucleic Acid(DNA)Techniques inSacharomyces CerevisiaeYeast,HepB-SCY]后,用雅培试剂化学发光法筛选出抗乙肝病毒表面抗原抗体[Antibody to Hepatitis B Virus(HBV)Surface Antigen(HBsAg),AntiHBs]滴度<100毫国际单位/毫升(mIU/ml)、且HBsAg和抗乙肝病毒核心抗原抗体(Antibody to HBV CoreAntigen,Anti-HBc)为阴性的婴儿为研究对象。随后分为2组,按照0、1、6个月免疫程序分别再免疫不同种类的重组HepB,用放射免疫法检测再免疫前、再免疫1剂后和再免疫3剂后的Anti-HBs,比较再免疫前后Anti-HBs的变化,以及不同种类疫苗、不同基础免疫状态的再免疫抗体应答。结果研究对象再免疫前、再免疫1剂和再免疫3剂后,Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为25.02、176.56、200.68mIU/ml,再免疫1剂、3剂后与再免疫前GMC差异有统计学意义(F=75.006,P=0.000),再免疫1剂与3剂间差异无统计学意义(t=-1.575,P=0.123)。再免疫1剂和3剂后与再免疫前相比,5μg HepB-SCY和10g重组HepB(汉逊酵母)(HepB Made by DNA Techniques inHansenula PolymorphaYeast,HepB-HPY)两组间GMC增长的差异均无统计学意义(t=1.807,P=0.078;t=1.602,P=0.118);无应答组再免疫1剂后GMC低于低应答组,但再免疫3剂后其GMC差异无统计学意义(t=-0.0437,P=0.664)。结论对HepB-SCY5μg三剂免疫后的低/无应答婴儿进行再免疫后抗体应答良好;5μgHepB-SCY和10g HepB-HPY再免疫的抗体应答相似。
Objective To evaluate the antibody response to re-immunization of low / non-responders after neonatal inoculation with Hepatitis B Vaccine (HepB). Methods Newborn infants were vaccinated with HepB (HepB Made by Recombinant Deoxyribonucleic Acid (DNA) Techniques in Saccharomyces Cerevisiae Yeast, HepB-SCY) with 0, 1 and 6 months of immunization. Antibody to Hepatitis B Virus (HBV) Surface Antigen (HBsAg), AntiHBs] was screened by reagent chemiluminescence method for the titer of <100 mIU / ml, and HBsAg and anti-hepatitis B virus Antibodies to HBV CoreAntigen (Anti-HBc) were negative in this study. Then divided into 2 groups, re-immunized different types of recombinant HepB by 0, 1 and 6 months respectively, Anti-HBs detected by radioimmunoassay before re-immunization, 1 re-immunization and 3 re-immunization, The changes of Anti-HBs before and after re-immunization were compared with those of different kinds of vaccines and different basic immune states. Results Before and after re-immunization, re-immunization of 1 dose and re-immunization of 3 doses of Anti-HBs Geometric Mean Concentration (Geometric Mean Concentration, GMC) were 25.02,176.56,200.68mIU / ml, There was a significant difference between pre-immunization and GMC before immunization (F = 75.006, P = 0.000). There was no significant difference between the re-immunization of 1 and 3 doses (t = -1.575, P = 0.123). There was no difference in GMC growth between 5μg HepB-SCY and 10g recombinant HepB (HepB Made by DNA Techniques in Hansenula PolymorphaYeast, HepB-HPY) compared with that before re-immunization The GMCs in the non-response group were lower than those in the low-response group after one dose of immunization, but there was no significant difference in the GMCs after the third immunization (t = 1.807, P = 0.078; t = 1.602, P = 0.118) t = -0.0437, P = 0.664). Conclusion The antibody response to HepB-SCY5μg three-dose immunized low / non-responders was good after immunization. The antibody responses of 5μg HepB-SCY and 10g HepB-HPY were similar.