肾综合征出血热Vero传代细胞疫苗的研究

Studies on Vero Cell-derived Hemorrhagic Fever with Renal Syndrome Vaccine

目的 研究肾综合征出血热 (HFRS)Vero传代细胞疫苗。方法 将HFRS双价沙鼠肾细胞灭活疫苗的生产疫苗株Z10 (Ⅰ型 )、Z3 7(Ⅱ型 )适应到Vero细胞上进行连续传代 ,并用不同代次的Vero细胞适应株制备Vero传代细胞疫苗。结果 Z10 、Z3 7株感染Vero细胞后第 1代即可达到较高病毒滴度 ,并且在Vero细胞中持续传代适应 ,病毒滴度分别维持在 6.2 5～ 6.75和 6.5 0～ 7.0 0logTCID50 /ml之间 ,较为稳定。用不同代次的Vero细胞适应株制备而成的HFRSVero细胞灭活疫苗抗原效价和疫苗的病毒滴度有较大提高 ,反向间接血凝效价从Z10 Cp1Vero细胞疫苗的阴性上升到Z10 Cp10 Vero细胞疫苗的 1∶64 ,从Z3 7Cp1Vero细胞疫苗的 1∶2上升到Z3 7Cp10 Vero细胞疫苗的 1∶64 ;疫苗病毒滴度(logTCID50 /ml)从Z10 Cp1Vero细胞疫苗的 4.2 5上升到Z10 Cp10 Vero细胞疫苗的 6.5 0 ,从Z3 7Cp1Vero细胞疫苗的 6.2 5上升到Z3 7Cp10 Vero细胞疫苗的 7.5 0。疫苗在抗原量和病毒滴度上基本符合中国生物制品的要求。结论 HFRSVero传代细胞疫苗的生产 ,疫苗株在Vero细胞中的连续传代适应起关键性作用。

Objective Vero cell derived HFRS purified vaccine researching and producing. Methods The vaccinal strains Z 10 (type Ⅰ)and Z 37 (type Ⅱ)of HFRS bivalent inactivated vaccine were adapted in vero cells and continuously porpagated. The Vero cell derived HFRS purified vaccine were developed using the different passages of these 2 viral strains. Results The strains Z 10 and Z 37 were adapted to Vero cells and grew on cells with high titers only after one time passages. The viral titers reached and maintained stably between 6.25 6.75 and 6.50 7.00 logTCID 50 /ml respectively after serial passages in Vero cells. The amounts of virus antigen and viral titers of Vero cell derived HFRS inactivated vaccine made from different passages of these viral strains were much higher than the former. The RPHI titers of strains Z 10 increased from negative for Cp 1 to 1∶64 for Cp 10 , and that of strains Z 37 from 1∶2 for Cp 1 to 1∶64 for Cp 10 . The viral titers ( logTCID 50 /ml ) of strains Z 10 raised from 4.25 for Cp 1 to 6.50 for Cp 10 and that of strains Z 37 from 6.25 for Cp 1 to 7.50 for Cp 10 . The viral titers and the amounts of virus antigen were up to the standand of biological products in China. Conclusion In the study on the HFRS purified vaccine in Vero cells,the most important thing is the passage adaptability of vaccinal strain in Vero cells.