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目的观察成人接种不同剂量重组乙型肝炎(乙肝)疫苗(汉逊酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques inHansenrla PolymorphaYeast,HepB-HPY)的免疫学效果。方法选择无HepB接种史和接种禁忌证,实验室筛检乙肝病毒(Hepatitis B Virus,HBV)标志物乙肝病毒表面抗原(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均阴性,丙氨酸氨基转移酶正常,年龄≥15岁的在校学生1600人作为观察对象。采用随机、双盲、对照原则,将入选的观察对象分为两组,每组各800人,以0、1、6个月全程免疫程序,分别接种20微克(g)和10 g HepB-HPY,受试者在免疫前、全程免疫后第4周采集静脉血,检测Anti-HBs。结果20 g组和10 g组Anti-HBs阳性[≥10毫国际单位/毫升(mIU/ml)]率分别为99.41%和98.03%,Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)分别为1511.88mIU/ml和1398.32mIU/ml。结论成人接种20 g和10 g HepB-HPY的免疫学效果良好,接种20 g HepB-HPY免疫学效果更好。
Objective To observe the immunological effects of Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Hansenrla PolymorphaYeast (HepB-HPY). Methods None of HepB vaccination history and vaccination contraindications were selected. Laboratory screening of Hepatitis B Virus (HBV) markers HBsAg, Antibody to HBsAg -HBs), anti-hepatitis B virus core antigen antibody were negative, alanine aminotransferase normal, age ≥ 15-year-old in-school students 1,600 as the observation object. The randomized, double-blind, control principle, the selected subjects were divided into two groups, each 800 people, 0,1,6 months of the entire immune program, were inoculated with 20 micrograms (g) and 10 g HepB-HPY , The subjects before immunization, 4 weeks after the whole immune blood was collected to detect anti-HBs. Results The positive rates of Anti-HBs (≥10 mIU / ml) in 20 g and 10 g groups were 99.41% and 98.03%, respectively. The Geometric Mean Concentration (GMC) of Anti-HBs were 1511.88 mIU / ml and 1398.32 mIU / ml. Conclusion The immunological effects of 20 g and 10 g HepB-HPY inoculated adults were good, and immunization with 20 g HepB-HPY was better.