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; 1 O3 chimpanzee-infectious doses (CID,,) of hepatitis-B virus (HBV), subjected to the purification steps during production of
Inactivation of 12 viruses by heating steps applied during manufacture of a hepatitis B vaccine
โ Scribed by Dr. P. N. Lelie; H. W. Reesink; C. J. Lucas
- Publisher
- John Wiley and Sons
- Year
- 1987
- Tongue
- English
- Weight
- 314 KB
- Volume
- 23
- Category
- Article
- ISSN
- 0146-6615
No coin nor oath required. For personal study only.
โฆ Synopsis
The efficacy of two heating cycles (90 sec at 103 O C and 10 hr at 65 "C) used during manufacture of a plasma-derived hepatitis-B vaccine was validated for the inactivation of 12 virus families. A period of 15 min warming up to 65 O C had already completely inactivated representatives of nine virus families, ie, poxvirus (vaccinia), picornavirus (encephalomyocarditis virus), togavirus (sindbis virus), coronavirus (mouse hepatitis virus), orthomyxovirus (influenza virus), rhabdovirus (vesicular stomatitis virus), herpes virus (cytomegalovirus), lentivirus (human immunodeficiency virus), and retrovirus (murine leukemia virus). After prolonged heating at 65 O C or heating for 90 sec at 103 "C, parvovirus (canine parvovirus) and the phage phiX174 were also completely inactivated. Papovavirus represented by simian virus 40 (SV-40) was the most heat-resistant virus evaluated. The infectivity of SV-40 was reduced by lo4 Tissue Culture Infectious Doses (TCIDSo) per ml after 90 sec at 103 O C , but a marginal residual activity ( t l . 5 TCID,, per ml) was observed. Subsequent pasteurization for 10 h at 65 "C did not further reduce the infectivity of SV-40. This study shows that the two heat-inactivation steps used during the production of this vaccine kill a wide variety of viruses that might be present in human blood.
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In a randomized, dose-response study among 305 health care workers, we examined whether the immunogenicity of a heat-inactivated hepatitis B vaccine could be enhanced when HBsAg was complexed by anti-HBs contained in hepatitis B immunoglobulin either at equivalent proportions or at 10-fold antigen e