人用精制Vero细胞狂犬病疫苗的研制

Preparation of Purified Rabies Vaccine for Human Use with Vero Cell

目的 应用Ｖｅｒｏ细胞研制人用精制狂犬病疫苗。方法应用Ｖｅｒｏ细胞经转瓶或生物反应器培养制备人用精制江大病疫苗。结果各项质控指标均符合ＷＨＯ和中国生物制品规程标准，经Ｉ期临床观察疫苗是安全的。结论用Ｖｅｒｏ细胞生产的狂犬病疫苗产量大，效价高，不良反应少，且能进行工业化生产。

Objective To prepare purified rabies vaccine for human use with Vero cell.Methods The vaccine was prepared with Vero cells cultured in rolling flask or bioreactor. Results All the indexes of the vaccine met WHO or Chinese Requirements of Biological Products. The vaccine was proved to be safe by a phase I clinical trial. Conclusion The rabies vaccine prepared with Vero cell shows good yield,high titer and few adverse reaction, so it is suitable for ho scale production.