在制备热灭活乙型肝炎疫苗过程中使10（15）个黑猩猩感染剂量的乙型肝炎病毒失活。

Inactivation of 10(15) chimpanzee-infectious doses of hepatitis B virus during preparation of a heat-inactivated hepatitis B vaccine.

作者信息

Lelie P N, Reesink H W, Niessen J, Brotman B, Prince A M

机构信息

Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam.

出版信息

J Med Virol. 1987 Nov;23(3):289-95. doi: 10.1002/jmv.1890230312.

DOI:10.1002/jmv.1890230312

PMID:2963091

Abstract

The safety of a plasma-derived hepatitis-B vaccine inactivated by two heating steps (90 sec at 103 degrees C followed by 10 hr pasteurization at 65 degrees C) was validated in chimpanzees; 10(3) chimpanzee-infectious doses (CID50) of hepatitis-B virus (HBV), subjected to the purification steps during production of the vaccine, were noninfectious in two chimpanzees. Furthermore, 10(6) CID50 of HBV heated at 103 degrees C for 90 sec and another 10(6) CID50 of HBV heated at 65 degrees C for 10 hr, were also not infectious in two other chimpanzees. All animals developed hepatitis-B infection after subsequent challenge with the untreated starting material, before the respective purification and inactivation procedures. Thus, the total reduction of infectivity of HBV during production of this vaccine was established to be at least 10(15) CID50.

摘要

一种经两步加热（103摄氏度下90秒，随后65摄氏度巴氏消毒10小时）灭活的血浆源性乙肝疫苗的安全性在黑猩猩身上得到了验证；在疫苗生产过程中经过纯化步骤的10³个黑猩猩感染剂量（CID50）的乙肝病毒（HBV），对两只黑猩猩没有传染性。此外，10⁶个CID50的HBV在103摄氏度下加热90秒以及另外10⁶个CID50的HBV在65摄氏度下加热10小时，对另外两只黑猩猩也没有传染性。在各自的纯化和灭活程序之前，所有动物在随后用未处理的起始材料进行攻击后都发生了乙肝感染。因此，这种疫苗生产过程中HBV传染性的总降低被确定为至少10¹⁵个CID50。