接种不同剂量重组乙型肝炎疫苗(酵母、汉逊酵母)的血清抗体应答

Serum Antibody Response to Different Doses of Hepatitis B Vaccine Made by Recombinant DNA Techniques in Yeast and Hansenula Polymorpha Yeast

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 observe the serum antibody response of the population,whose hepatitis B virus surface antige（nHBsAg）、antibody to hepatitis B virus surface antige（nAnti-HBs）、antibody to hepatitis B virus core antigen（Anti-HBc）are all negative to the different doses of Hepatitis B vaccine made by recombinant DNA techniques in Yeast and Hansenula Polymorpha Yeast.Methods Collecting the blood of population vaccinated after 28 to 45 days,the serological method was used to detect Anti-HBs. Results The Anti-HBs positive rate and GMC of 5μg HepB-Y in the population16 years old whose HBsAg、Anti-HBs,Anti-HBc negative are 97.23%and 199.26mlU/ml,the Anti-HBs positive rate and GMC of 10μg HepB-HPY are 100.00%and 270.71mlU/ml,the Anti-HBs positive rate and GMC both have significant difference.The Anti-HBs positive rate and GMC of 10μg HepB-Y in the population≥16 years old whose HBsAg,Anti-HBs,Anti-HBc negative are 88.72%and 101.19mlU/ml.Anti-HBs positive rate and GMC of 10μg HepB-HPY are 94.20%and 162.17mlU/ml,the Anti-HBs positive rate and GMC both have significant difference.Conclusions The population whose HBsAg,Anti-HBs,Anti-HBc negative vaccinated by HepB-Y、HepB-HPY can get better Anti-HBs response.The population younger than sixteen years old vaccinated by 10μg HepB-HPY can get Anti-HBs positive rate and GMC higher than vaccinated by 5μg HepB-Y.The Anti-HBs response of HepB-HPY is better than HepB-Y in the population≥16 years old.