Fanget B, Françon A
Pasteur Merieux sérums & vaccins, Marcy l'Etoile, France.
Dev Biol Stand. 1996;87:167-71.
Varicella-Zoster virus (VZV), which causes Chicken Pox and Zoster, belongs to the Herpes viridae family [1, 2]. The virus is strongly cell dependent and its in vitro stability is very low. Following Takahashi's work, we have developed and prepared a vaccine with the OKA strain virus in the Japanese stabilizer. To improve the stability of the virus in a freeze-dried form, we have finalized a new formulation of stabilizer, called V 15-1. This stabilizer is a protein-free solution with defined contents of amino acids, salts and sugars. Comparative stability studies between the Japanese stabilizer and V 15-1 have been performed at different temperatures. We have demonstrated good stability for two years at + 5 degrees C and at + 25 degrees C and + 37 degrees C for the vaccine in freeze-dried form. We have also found a good stability of this vaccine at + 5 degrees C and + 25 degrees C after reconstitution. The use of V 15-1 thus allows us to prepare a Varicella vaccine with the OKA strain (> 2000 PFU per dose) which has good stability at 5 degrees C. A Varicella vaccine using a live attenuated virus strain OKA was developed in 1974 by Takahashi in Japan [3, 4]. The virus was isolated from vesicular fluid collected from a child with chicken pox. After propagation in human embryonic lung cells (HEC), guinea pigs embryonic cells (GPE) and human diploid cells (WI 38), the virus was attenuated. All the licensed vaccines are prepared with the OKA strain [5].
引起水痘和带状疱疹的水痘-带状疱疹病毒(VZV)属于疱疹病毒科[1,2]。该病毒对细胞依赖性很强,其体外稳定性非常低。继高桥的工作之后,我们使用日本稳定剂研制并制备了含OKA株病毒的疫苗。为提高冻干形式病毒的稳定性,我们最终确定了一种名为V 15-1的新型稳定剂配方。这种稳定剂是一种无蛋白溶液,含有特定含量的氨基酸、盐和糖。已在不同温度下对日本稳定剂和V 15-1进行了稳定性比较研究。我们已证明,冻干形式的疫苗在+5摄氏度、+25摄氏度和+37摄氏度下两年内稳定性良好。我们还发现,复溶后的该疫苗在+5摄氏度和+25摄氏度下稳定性良好。因此,使用V 15-1使我们能够制备每剂含>2000 PFU的OKA株水痘疫苗,该疫苗在5摄氏度下具有良好的稳定性。1974年,高桥在日本研制出一种使用减毒活病毒株OKA的水痘疫苗[3,4]。该病毒是从一名水痘患儿的水疱液中分离出来的。在人胚肺细胞(HEC)、豚鼠胚细胞(GPE)和人二倍体细胞(WI 38)中传代后,病毒被减毒。所有已获许可的疫苗均采用OKA株制备[5]。