Serum-free produced Bovine Herpesvirus type 1 and Bovine Parainfluenza type 3 virus vaccines are efficacious and safe
Serum-free produced Bovine Herpesvirus type 1 and Bovine Parainfluenza type 3 virus vaccines are efficacious and safe
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DOI：
10.1023/a:1023982003258
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发表时间：
2002-01-01
期刊：
影响因子：
2.2
通讯作者：
van Gelder, PTJA
中科院分区：
文献类型：
--
作者：
Makoschey, B;Patel, JR;van Gelder, PTJA
进行本报告中描述的研究以确定是否可能在任何细胞或病毒传代期间生产不含血清或其组分的活病毒疫苗，从而完全不含血清。实验中包括两种病毒：牛疱疹病毒1型（BHV-1）和牛副流感病毒3型（PI 3）。发现两种病毒都能生长到令人满意的滴度，并且在冷冻干燥和随后在+4 ℃和-20 ℃的温度下储存至少一年后保持稳定。此外，在接种-攻击实验中测试了含有无血清产生的BHV-1的疫苗。为了进行比较，研究中包括了在含血清细胞培养基中生长的BHV-1疫苗批次。两种疫苗制剂的表现同样良好，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，已经证明了过量和重复给药后，甚至在非常年幼的小牛中，甚至在四次给药后，无血清生产的BHV-1和PI 3的安全性。这是第一份报告，据我们所知，它证明了无血清生产的活疫苗在靶动物中的安全性和有效性以及这些产品的稳定性。
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 degreesC and -20 degreesC 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.