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Inactivation of 10 15 chimpanzee‐infectious doses of hepatitis B virus during preparation of a heat‐inactivated hepatitis B vaccine
Author(s) -
Lelie P. N.,
Reesink H. W.,
Niessen J.,
Brotman B.,
Prince A. M.
Publication year - 1987
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.1890230312
Subject(s) - virology , infectivity , hepatitis b virus , hepatitis b , infectious dose , virus , hepatitis , orthohepadnavirus , hepadnaviridae , medicine , biology
The safety of a plasma‐derived hepatitis‐B vaccine inactivated by two heating steps (90 sec at 103 °C followed by 10 hr pasteurization at 65 °C) was validated in chimpanzees; 10 3 chimpanzee‐infectious doses (CID 50 ) of hepatitis‐B virus (HBV), subjected to the purification steps during production of the vaccine, were noninfectious in two chimpanzees. Furthermore, 10 6 CID 50 of HBV heated at 103 °C for 90 sec and another l0 6 CID 50 of HBV heated at 65 °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 CID 50 .