Burnette W N, Samal B, Browne J, Ritter G A
Dev Biol Stand. 1985;59:113-20.
The gene for hepatitis B surface antigen was cloned into vectors for expression in yeast and mammalian cells. These hosts assemble the surface antigen protein into spherical structures containing cell-derived lipids. Particles were isolated from these cell cultures and purified by standard biochemical and biophysical means. Protein micells were formed from such particles by removal of lipid with nonionic detergent. Both particle and protein micellar preparations were formulated with alum adjuvant and tested for their immunopotency in mice. All the materials so analysed proved to be highly immunogenic. Safety and regulatory aspects of these materials and other potential and current hepatitis B vaccines are discussed. It is concluded that the yeast-derived materials and certain mammalian cell production systems present the most suitable opportunities for new hepatitis B vaccines.
乙型肝炎表面抗原基因被克隆到载体中，以便在酵母和哺乳动物细胞中表达。这些宿主将表面抗原蛋白组装成含有细胞来源脂质的球形结构。从这些细胞培养物中分离出颗粒，并通过标准的生化和生物物理方法进行纯化。通过用非离子洗涤剂去除脂质，从这些颗粒中形成蛋白质胶束。颗粒制剂和蛋白质胶束制剂均与明矾佐剂一起配制，并在小鼠中测试其免疫效力。所有经分析的材料均被证明具有高度免疫原性。讨论了这些材料以及其他潜在和现有的乙型肝炎疫苗的安全性和监管方面。得出的结论是，酵母衍生材料和某些哺乳动物细胞生产系统为新型乙型肝炎疫苗提供了最合适的机会。
