不同剂量国产重组酵母乙肝疫苗对成人免疫效果观察

Observation on Immunogenicity of Yeast Derived Recobinanthepatitis B Vaccine in Adults

摘要: 目的观察国产重组酵母乙肝疫苗(YDV)对成人的安全性和免疫学效果,为制定成人免疫策略提供依据。方法应用不同剂量的重组酵母乙肝疫苗对199名18～55岁健康人群进行免疫效果观察。结果接种对象未发现中、重的局部和全身副反应。全程免疫后1个月,接种5μg、10μg疫苗组的表面抗体(anti-HBs)阳转率分别为89.25%,98.5%;anti-HBs平均几何滴度(GMT)分别为18.88mIU/ml,54.47mIU/ml,GMT有显着性差异。结论国产重组酵母乙肝疫苗成人免疫安全性好,成人接种10μgYDV疫苗能产生很高的乙肝表面抗体滴度。

Abstract: Objective To evaluate the safety and immunogenicity of yeast recombinanthepatitis B vaccine(YDV)produced in China and accumulate data for formulating an adult immunization strategy.Methods One hundred and ninety-nine health adults were grouped randomly and vaccinated with different doses of YDV.The side-effects were monitored and blood samples were taken for anti-HBs testing.Results No serious general and local side response was found in all adults.After one month that immunization program was completed,89.25% of subjects were detected anti-HBs in 5μg inoculating group and 98.5% in 10μg inoculating group.The geomtric mean titres(GMT)of anti-HBs were 54.47mIU/ml in 10μg group and 18.8mIU/ml in 5μg group(P<0.05).Conclusion YDV produced in China was safe in adults.Inoculation with 10μg could yield very high anti-HBs titre.