Department of Virological R&D, Intervet International B.V., Boxmeer, 5839 AA, The Netherlands.
Cytotechnology. 2002 Sep;39(3):139-45. doi: 10.1023/A:1023982003258.
The studies described in this report were performed to determine, whether it is possible to produce live virus vaccines without serum or fractions thereof used during any cell or virus passage, thus completely serum-free. Two viruses were included in the experiments: Bovine Herpesvirus 1 (BHV-1) and Bovine Parainfluenza type 3 virus (PI3). Both viruses were found to grow to satisfactory titers, and to be stable after freeze-drying and subsequent storage at temperatures of +4 degrees C and -20 degrees C for at least one year. Moreover, a vaccine containing serum free produced BHV-1 was tested in a vaccination-challenge experiment. For comparison, a vaccine batch with BHV-1 grown in serum-containing cell culture medium was included in the study. Both vaccine preparations performed equally well and both met the strict requirements as laid down in the European Phamacopeia. Moreover, in two separate experiments the safety of serum-free produced BHV-1 and PI3 after overdose and repeated administration even in very young calves and even after four administrations has been demonstrated. This report is the first, which to our knowledge demonstrates the safety and efficacy of serum-free produced live vaccines in the target animal as well as the stability of these products.
本报告中描述的研究旨在确定是否可以生产不含血清或其在任何细胞或病毒传代过程中使用的部分的活病毒疫苗,从而实现完全无血清。实验中包括两种病毒:牛疱疹病毒 1(BHV-1)和牛副流感 3 型病毒(PI3)。两种病毒的生长都达到了满意的滴度,并且在冻干后在+4°C 和-20°C 的温度下储存至少一年后仍然稳定。此外,还在接种-挑战实验中测试了含有无血清生产的 BHV-1 的疫苗。为了进行比较,研究中还包括了用含血清的细胞培养基培养的 BHV-1 生产的疫苗批次。两种疫苗制剂的效果相当,均符合欧洲药典规定的严格要求。此外,在两项单独的实验中,证明了在过量和重复给药后,甚至在非常年幼的犊牛中,甚至在进行了四次给药后,无血清生产的 BHV-1 和 PI3 的安全性。据我们所知,本报告首次证明了无血清生产的活疫苗在目标动物中的安全性和有效性,以及这些产品的稳定性。