Inactivation of 1015 chimpanzee‐infectious doses of hepatitis B virus during preparation of a heat‐inactivated hepatitis B vaccine

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Abstract
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; 103 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, 106 CID50 of HBV heated at 103 °C for 90 sec and another l06 CID50 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 1015 CID50.