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目的 研制包含Ⅰ型和Ⅱ型病毒抗原的肾综合征出血热纯化疫苗 ,以提高疫苗质量及临床应用效果。方法 用金黄地鼠肾细胞培养的PS 6株 (Ⅰ型 )病毒和L99株 (Ⅱ型 )病毒以体积比 1∶1的比例配制成双价疫苗 ,经醋酸锌沉淀、超滤浓缩、Sepharose 4FF柱层析制备成双价纯化疫苗。结果 双价纯化疫苗经中国药品生物制品检定所检测 ,各项指标全部合格。疫苗于 37℃放置 2周和 4℃放置 3年 ,效力试验均合格。临床观察血清中和抗体阳转率大于 85 % ,仅出现 0 .5 %的轻反应。结论 研制的出血热双价纯化疫苗 ,各项质量指标均符合《双价肾综合征出血热纯化疫苗试行规程》的要求 ,临床应用效果良好
Objective To develop a vaccine against hemorrhagic fever with renal syndrome that contains type I and type II virus antigens to improve vaccine quality and clinical application. Methods PS 6 strain (type Ⅰ) and L99 strain (type Ⅱ) virus were cultured in golden hamster kidney cells in a volume ratio of 1: 1 to prepare a bivalent vaccine. The cells were precipitated with zinc acetate and concentrated by ultrafiltration. Sepharose 4FF Column chromatography prepared bivalent purified vaccine. Results The bivalent purified vaccine was tested by China National Institute for the Control of Pharmaceutical and Biological Products with all the indicators passed. The vaccine was placed for 2 weeks at 37 ° C and for 3 years at 4 ° C. The efficacy test was satisfactory. Clinical observations Serum neutralizing antibody positive rate of more than 85%, only 0.5% of the light reaction. Conclusions The dual-purified vaccine for hemorrhagic fever developed and the quality indicators are in line with the requirements of “Trial Regulation of Hemorrhagic Fever with Double-price Renal Syndrome” and the clinical application is good