两种剂量国产重组酵母乙型肝炎疫苗用于成人免疫效果评价

Evaluation on effect of different doses of domestic recombinant yeast-derived hepatitis B vaccine on adult immunization

目的观察国产重组酵母（CHO）乙型肝炎（乙肝）疫苗（10和20μg）免疫接种后机体体液免疫变化，以及接种不良反应情况，以确定适合成人免疫接种方案。方法对符合选择标准的222名研究对象，采用随机双盲对照试验，按照免疫程序分别接种10和20μgCHO乙肝疫苗，并于接种第3针1个月后采血，检测抗-HBs滴度值（雅培化学发光的方法），对抗-HBs阴性者进一步检测乙肝病毒（HBV）DNA（荧光定量PCR方法）。结果两种剂量组抗-HBs阳转率分别为89．47％（95％CI：83．75％-95．19％）和99．07％（95％CI：97．24％-100．00％），低无应答率分别为39．47％和13．89％，抗体几何平均滴度（GMT）分别为134．57和921．11mU／ml。结论CHO乙肝疫苗具有较好的安全性和免疫原性，两种剂量中20μg成人免疫效果优于10μg，是较为理想的接种剂量。

[ Objective] To observe the changes of humoral immunity after the immunization by domestic recombinant yeast-derived （ CHO） hepatitis B vaccine （ 10 μg and 20 μg} , and the adverse reaction of vaccination, determine the appropriate adult immuni-zation program. [ Methods ] By using the double-blind randomized clinical trial, 222 subjects who met the selection criteria were re-spectively given 10 p.g and 20 p.g CHO hepatitis B vaccine according to the immunization program. The blood samples were collect-ed 1 month after the third dose, to detect the anti-HBs titer （ Abbott chemiluminescence method ） , and the anti-HBs negative sam- ples were tested for HBV DNA further （fluorescence quantitative PCR）. [ Results ] The positive conversion rate of two dose groups was respectively 89.47% （ 95% CI：83.75% -95.19% ） and 99.07% （ 95% CI：97.24% -100.00% ） , non-and-low response rate was respectively 39.47% and 13.89%, while the antibody geometric mean titer （GMT） was respectively 134.57 mU/ml and 921.11 mU/ml. [Condusion]CHO hepatitis B vaccine is safe and has good immunogenieity, and dose of 20 μg has better effect than dose of 10 μg, which is the appropriate dose.