Inactivation of hepatitis B virus by three methods: Treatment with pepsin, urea, or formalin
作者:
Edward Tabor,
Eugene Buynak,
Linda A. Smallwood,
Philip Snoy,
Maurice Hilleman,
Robert J. Gerety,
期刊:
Journal of Medical Virology
(WILEY Available online 1983)
卷期:
Volume 11,
issue 1
页码: 1-9
ISSN:0146-6615
年代: 1983
DOI:10.1002/jmv.1890110102
出版商: Wiley Subscription Services, Inc., A Wiley Company
关键词: formalin;hepatitis B;inactivation;pepsin;urea;vaccine
数据来源: WILEY
摘要:
AbstractDilutions of human sera containing between 103and 105chimpanzee infectious doses of hepatitis B virus per ml, subtype adr or ayw, were treated with either 1 m̈g/ml pepsin at pH 2.0 for 18 hours, 8 M urea for four hours, or 1:4,000 formalin for 72 hours. One ml of the serum containing hepatitis B virus subjected to each of the procedures was inoculated intravenously into one or two susceptible chimpanzees (total of eight chimpanzees). No evidence of hepatitis B infection was detected in weekly serum samples from the chimpanzees during six months of observation. These three procedures are currently applied during manufacture to inactivate HBV which might be present in the hepatitis B vaccine licensed in the United States. The data from this study combined with data documenting that the physical purification of the vaccine is capable of removing hepatitis B virus provide assurance that there is no residual live hepatitis B virus in the vaccine
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