公开(公告)号：EP2055311B1

公开(公告)日：2017-06-21

申请号：EP07792040.3

申请日：2007-08-06

申请人： The Chemo-Sero-Therapeutic Research Institute ,  JAPAN as represented by DIRECTOR GENERAL OF NATIONAL INSTITUTE OF INFECTIOUS DISEASES

发明人： KANEHARA, Tomomi ,  YOKOTE, Hiroyuki ,  OHKUMA, Kunio ,  KURANAGA, Masahiko ,  MORIKAWA, Shigeru

IPC分类号： A61K39/285

CPC分类号： A61K39/275 ,  A61K39/12 ,  A61K2039/5254 ,  C12N2710/24134

公开(公告)号：EP2055311A1

公开(公告)日：2009-05-06

申请号：EP07792040.3

申请日：2007-08-06

申请人： Juridical Foundation The Chemo-Sero-Therapeutic Research Institute ,  JAPAN as represented by DIRECTOR GENERAL OF NATIONAL INSTITUTE OF INFECTIOUS DISEASES

发明人： KANEHARA, Tomomi ,  YOKOTE, Hiroyuki ,  OHKUMA, Kunio ,  KURANAGA, Masahiko ,  MORIKAWA, Shigeru

IPC分类号： A61K39/285

CPC分类号： A61K39/275 ,  A61K39/12 ,  A61K2039/5254 ,  C12N2710/24134

摘要： A safer live smallpox vaccine, which contains a lowered content of revertants, is provided. A process for manufacturing a live smallpox vaccine which comprises steps of: inoculating a master seed solution of an attenuated vaccinia virus to an appropriate number of containers (1 to n wherein n is an integer) of rabbit kidney cells and incubating them; inoculating a portion of the cultured solution obtained from each container to RK-13 cells and to Vero E6 cells and incubating them to thereby select containers which contain a cultured solution that forms plaques in RK-13 cells but not in Vero E6 cells; and preparing a drug substance of vaccine using the aforementioned cultured solution (working seed solution), and a live smallpox vaccine prepared in the aforementioned process.

摘要翻译： 提供了一种更安全的活的天花疫苗，其中含有较低含量的反转体。 一种活体天花疫苗的制造方法，其特征在于，包括以下步骤：将减毒的痘苗病毒的母种子溶液接种到兔肾细胞的合适数量的容器（1〜n，n为整数）中并孵育; 将从每个容器获得的培养溶液的一部分接种到RK-13​​细胞和Vero E6细胞，并将其孵育，从而选择含有在RK-13​​细胞中形成斑块但不在Vero E6细胞中的培养溶液的容器; 并使用上述培养液（工作种子溶液）制备疫苗的药物物质，以及在上述方法中制备的活天花疫苗。