Barth R, Gruschkau H, Jaeger O, Milcke L, Weinmann E
Behring Inst Mitt. 1984 Nov(76):142-54.
A new inactivated rabies vaccine (Purified Chick Embryo Cell vaccine) for use in humans has been developed. The FLURY-LEP C25 strain of rabies virus was adapted to propagate in primary chick embryo cell cultures. The antigen was purified and concentrated by continuous density gradient centrifugation and inactivated by Betapropiolactone. The PCEC-rabies vaccine was tested for innocuity, tolerability and protective capacity in a series of laboratory tests and compared with Human Diploid Cell Strain rabies vaccine (HDCSV) of similar antigenicity. The results of the laboratory tests indicated that this new vaccine was excellently tolerated and that its protective activity met the high standard of HDCS-vaccine, conditions which were imposed on the PCEC-vaccine before clinical trials in man were initiated.
一种用于人类的新型灭活狂犬病疫苗(纯化鸡胚细胞疫苗)已研制成功。狂犬病病毒的弗吕里-LEP C25株经适应后可在原代鸡胚细胞培养物中繁殖。通过连续密度梯度离心法对抗原进行纯化和浓缩,并用β-丙内酯进行灭活。在一系列实验室试验中对PCEC狂犬病疫苗的无害性、耐受性和保护能力进行了测试,并与具有相似抗原性的人二倍体细胞狂犬病疫苗(HDCSV)进行了比较。实验室试验结果表明,这种新疫苗耐受性良好,其保护活性达到了HDCS疫苗的高标准,这些条件是在开始人体临床试验之前对PCEC疫苗所要求的。