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为评价新近研制出的哺乳动物细胞重组基因乙型肝炎疫苗(MCDVv)和重组牛痘毒病毒乙型肝炎疫苗(RVDV)能否推广使用,以及为国产重组酵母乙型肝炎疫苗(YDV)的发展提供方向,作者以国产注册使用的血源乙型肝炎疫苗(PDV)为参照组,在健康青年学生中,采用随机、双盲、对照实验,评价了美国Am-gen苗(YDV),比利时Smith苗(YDV),日本X苗(YDV),国产MCDV1和MCDV2(MCDV)苗及国产RVDV(RVDV)苗的免疫原性。结果表明,这7个疫苗均无严重副反应,安全可用;均能诱导机体产生保护水平的抗体(阳转率93%~100%)。但抗-HBs几何平均滴度(GMT)不同,以Amgen,Smith为最好,国产PDV,RVDV次之,可推广使用;在发展重组酵母乙型肝炎疫苗的生产时,应考虑Amgen和Smith公司的先进生产技术与工艺。
To evaluate whether the recently developed mammalian recombinant hepatitis B vaccine (MCDVv) and recombinant vaccinia virus hepatitis B vaccine (RVDV) can be used in the future and the development of domestic recombinant yeast hepatitis B vaccine (YDV) Direction, the author used the domestic registered blood-borne hepatitis B vaccine (PDV) as a reference group, in healthy young students, the use of randomized, double-blind, controlled experiments to evaluate the United States Am-gen seedlings (YDV), Japanese X (YDV), domestic MCDV1 and MCDV2 (MCDV) seedlings and domestic RVDV (RVDV) seedlings. The results showed that all seven vaccines had no serious adverse reactions and were safe to use. All of the seven vaccines were capable of inducing antibodies with protective levels (positive rate of 93% -100%). However, the geometric mean titers (GMT) of anti-HBs are different, with Amgen and Smith being the best, domestic PDV and RVDV being the second, which can be popularized. In the development of recombinant yeast hepatitis B vaccine, Amgen and Smith should be considered Advanced production technology and technology.