双价肾综合征出血热纯化疫苗的研究

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

Preparation of Purified Bivalent Haemorrhagic Fever with Renal Syndrome Vaccine

Objective To prepare purified bivalent haemorrhagic fever with renal syndrome(HFRS)vaccine containing virus antigens types Ⅰ and Ⅱ and improve its quality and immunogenicity.Methods Prepare bivalent HFRS vaccine by mixing the PS-6(type Ⅰ) and L99(type Ⅱ) strains cultured in primary hamster kidney cells(PHKC)at a volume ratio of 1∶1,and purify by precipitation with zinc acetate,concentration with ultrafiltration and Sepharose 4FF column chromatography.Results All the indexes of the purified bivalent HFRS vaccine were qualified in control tests in the NCL.The vaccine was qualified in potency test after storage at 37℃ for 2 weeks or at 4℃ for 3 years.The positive conversion rate of neutralizing antibody induced by the vaccine was above 85%,and only mild adverse reactions were observed in 5% of recipients.Conclusion The prepared vaccine met the (Trial)Requirements for Purified Bivalent Haemorrhagic Fever with Renal Syndome Vaccine and showed good quality and clinical effect.