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目的: 研制肾综合征出血热双价纯化疫苗。方法:肾综合征出血热病毒I型LR1 株和II型R22株分别在Vero细胞上接种培养。I、II型病毒培养液依次经β 丙内酯灭活、超滤浓缩、蔗糖区带离心纯化及层析脱糖等处理。将检定合格的I、II型单价病毒原液等量混合后, 用AI(OH)3 佐剂吸附,制备 3批双价纯化疫苗。结果: 该 3批疫苗已经自检和中国药品生物制品检定所复检合格, 并已进行临床试验。结论: 采用Vero细胞培养制备肾综合征出血热双价纯化疫苗方法可行。
Objective: To develop a dual purified vaccine against hemorrhagic fever with renal syndrome. Methods: Hemorrhagic fever with renal syndrome type I strain LR1 and type II strain R22 were inoculated on Vero cells respectively. The virus of type I and type II was inactivated by β-propiolactone, then concentrated by ultrafiltration, purified by centrifugation in sucrose and de-saccharified by chromatography. Will pass the same type I, II monovalent virus stock solution after mixing, with AI (OH) 3 adjuvant adsorption, prepared three batches of purified vaccine. Results: The three batches of vaccines have been self-tested and re-examined by the China National Institute for the Control of Pharmaceutical and Biological Products and have been tested in clinical trials. Conclusion: It is feasible to use Vero cell culture to prepare double-purified vaccine for hemorrhagic fever with renal syndrome.