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目的观察乙型肝炎(乙肝)病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]、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)阴性人群,全程接种不同剂量重组乙肝疫苗(酵母)[Hepatitis B Vaccine(HepB)Made by RecombinantDeoxyribonucleic Acid(DNA)Techniques in Yeast,HepB-Y]、重组乙肝疫苗(汉逊酵母)(HepB Made by RecombinantDNA Techniques in Hansenula Polymorpha Yeast,HepB-HPY)后的血清抗体应答。方法采集受种者接种后28～45d的静脉血,用固相放射免疫方法检测Anti-HBs。结果<16岁HBsAg、Anti-HBs、Anti-HBc均阴性人群,接种5μg HepB-Y后,Anti-HBs阳转率和几何平均浓度(Geometrical Mean Concentration,GMC)分别为97.23%和199.26mlU/ml(毫国际单位/毫升);接种10μg HepB-HPY后,Anti-HBs阳转率和GMC分别为100.00%和270.71mlU/ml,两组Anti-HBs阳转率和GMC差异均有统计学意义。≥16岁HBsAg、Anti-HBs、Anti-HBc均阴性人群,接种10μg HepB-Y后,Anti-HBs阳转率和GMC分别为88.72%、101.19mlU/ml;接种10μg HepB-HPY后Anti-HBs阳转率和GMC分别为94.20%、162.17mlU/ml,两组Anti-HBs阳转率和GMC差异均有统计学意义。结论HBsAg、Anti-HBs、Anti-HBc均阴性人群,接种HepB-Y、HepB-HPY后均能获得较好的Anti-HBs应答;<16岁人群接种10μg HepB-HPY后,能获得较接种5μg HepB-Y高的Anti-HBs阳转率和GMC;≥16岁人群接种HepB-HPY后,Anti-HBs应答优于接种HepB-Y。
OBJECTIVE: To investigate the anti-hepatitis B virus surface antigen (HBsAg), hepatitis B virus surface antigen (HBsAg), anti-HBsAg, anti-HBs, Hepatitis B Vaccine (HepB) Made by Recombinant Deoxyribonucleic Acid (DNA) Techniques in Yeast, HepB-Y], Recombinant Hepatitis B Vaccine (Hansenula ) (HepB Made by Recombinant DNA Techniques in Hansenula Polymorpha Yeast, HepB-HPY). Methods Venous blood samples from 28 to 45 days after inoculation were collected and anti-HBs were detected by solid-phase radioimmunoassay. Results Anti-HBs positive rate and Geometrical Mean Concentration (GMC) were 97.23% and 199.26 mlU / ml respectively after inoculation with 5μg HepB-Y (Ml international unit / ml); Anti-HBs positive rate and GMC were 100.00% and 270.71 mlU / ml after HepB-HPY was inoculated with 10μg of HepB-HPY respectively. There were significant differences in anti-HBs positive rate and GMC between the two groups. Anti-HBs anti-HBs positive rate and GMC were 88.72% and 101.19mlU / ml after inoculation with 10μg HepB-Y, respectively. After anti-HBs were inoculated with 10μg HepB-HPY The positive rate and GMC were 94.20% and 162.17 mlU / ml, respectively. There was significant difference between the two groups in the anti-HBs positive rate and GMC. Conclusions HBsAg, Anti-HBs, and Anti-HBc are negative in both groups. Anti-HBs response can be obtained after HepB-Y and HepB-HPY inoculation. After vaccination with 10μg HepB-HPY, Anti-HBs positive response to HepB-Y was higher than that of HepB-Y vaccinated with HepB-HPY and GMC.