冻干人用狂犬病疫苗(MRC-5细胞)非临床安全性研究

目的 对冻干人用狂犬病疫苗(MRC-5细胞)进行全身主动过敏试验、肌肉刺激性、单次给药毒性和溶血性评价,以考察其安全性.方法 本研究起止时间为2014年3月至2016年10月.按照确定的工艺和质量标准,使用人二倍体细胞MRC-5培养狂犬病固定毒株,灭活、纯化后制备冻干人用狂犬病疫苗,质量检定合格后,用于开展全面的动物毒...

Non-clinical safety of freeze-dried rabies vaccine (MRC-5 cell) for human

Objective To evaluate the safety of freeze-dried human rabies vaccine (MRC-5 cells) by performing active allergy test, muscle irritation evaluation, single administration toxicity and hemolytic.Methods The experimental study started and ended fromMarch 2014 to October 2016. Following the established processes and quality standards, rabies virus fixed strain was cultured in hu man diploid MRC-5 cell line, and then was inactivated and purified for preparing the freeze-dried rabies vaccine. After passing the QC test, the vaccine was used for a comprehensive animal toxicology test.Results In this experiment, excipients group containing humanalbumin, low dose, and high dose vaccine groups caused guinea pig allergy symptoms, the mortality rates after challenge on the 14thand 21st days were 0 (0/6), 0 (0/6), 16.67% (1/6) and 33.33% (2/6), 50.00% (3/6), 33.33% (2/6), there was no significant difference in