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目的探讨不同剂量与批号重组乙型肝炎(乙肝)疫苗(酵母)的免疫原性。方法选择505名5~20岁健康人,5μg、10μg重组乙肝疫苗(酵母)10批,按0、1、6个月免疫程序接种3针后1个月采血,进行免疫原性观察。结果各批乙肝疫苗乙肝病毒表面抗体(抗-HBs)阳转率达95.45%~100.00%,平均99.21%,几何平均浓度(GMC)为1 775.04毫国际单位/毫升(mIU/ml);5~7、8~10、11~13、14~16、18~20岁抗-HBs阳转率分别达99.04%~100.00%。GMC1 611.85mIU/ml~2 551.28mIU/ml;5μg、10μg乙肝疫苗抗-HBs阳转率分别达99.34%和98.03%,GMC分别达1 897.22mIU/ml和981.43mIU/ml。结论不同剂量与批号重组乙肝疫苗(酵母)免疫原性良好。
Objective To investigate the immunogenicity of hepatitis B vaccine (yeast) with different dose and batch number. Methods A total of 505 healthy volunteers aged 5-20 years, 5μg, 10μg recombinant hepatitis B vaccine (yeast) were randomly divided into 10 groups. Blood samples were collected 1 month after inoculation of 3 needles in 0, 1, and 6 months of immunization. Immunogenicity was observed. Results The positive rate of hepatitis B virus surface antigen (anti-HBs) was 95.45% -100.00% with an average of 99.21% and the mean geometric mean concentration (GMC) was 1775.04 milliUgIU / ml (mIU / ml) The positive conversion rates of anti-HBs at 7, 8-10, 11-13, 14-16, and 18-20 years old reached 99.04% -100.00% respectively. GMC1 611.85mIU / ml ~ 2 551.28mIU / ml; 5μg, 10μg Hepatitis B vaccine anti-HBs positive conversion rates were 99.34% and 98.03%, GMC were 1897.22mIU / ml and 981.43mIU / ml. Conclusion Different doses and batch recombinant hepatitis B vaccine (yeast) immunogenicity is good.