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目的我国的流行性出血热主要由汉滩型(HTN)和汉城型(SEO)病毒引起,疫苗的免疫接种是控制和预防本病发生的关键之举。现有的疫苗虽有较好的近期防病效果,但副反应多、抗体水平低,而且由于需要大量的动物种群以提供原代细胞的来源,造成环境污染而疫苗质量又难以控制。本专题的主要研究内容和目的就是用Vero细胞作为生产疫苗的基质,同时用现代较先进的浓缩纯化技术和检测手段,研制成精制双价疫苗。方法两型病毒分别在Vero细胞传代适应至高滴度,大量培养收获上清作为疫苗原液,采用超滤技术浓缩50～100倍,然后通过Sepharose4 FF柱纯化。认真测定抗原和蛋白含量、牛血清含量、细胞DNA含量及必要的试验,精心配制成Vero双价疫苗。结果按我国“生物制品规程”和出血热灭活疫苗临床试验最低标准进行全面系统鉴定,完全符合质量要求。正待批准进行人体临床试验。结论本品有可能作为现有疫苗的替代品。
Objective The epidemic hemorrhagic fever in our country is caused mainly by the Han-han type (HTN) and Seoul-type (SEO) viruses. Vaccination is the key to control and prevent this disease. Although the existing vaccines have a good effect of preventing diseases in recent days, they have many side reactions and low antibody levels, and the quality of the vaccine is hard to control because of the need of a large number of animal populations to provide the source of primary cells and environmental pollution. The main research content and purpose of this topic is to use Vero cells as the matrix for producing vaccines, and at the same time develop the purified bivalent vaccine with modern more advanced concentration and purification technologies and testing methods. Methods The two types of viruses were passaged in Vero cells to high titers respectively. A large number of harvested supernatants were used as vaccine stock and concentrated 50-100 times by ultrafiltration and then purified by Sepharose 4 FF column. Carefully determine the antigen and protein content, bovine serum content, cellular DNA content and the necessary tests carefully formulated into Vero bivalent vaccine. Results According to the “Biological Products Regulations” and the minimum standards of clinical trials for inactivated vaccine for haemorrhagic fever, we conducted a comprehensive systematic appraisal in full compliance with the quality requirements. Approved for human clinical trials. Conclusion This product may serve as an alternative to existing vaccines.