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Failure to detect infectious hepatitis b virus using high dose safety test for hepatitis b vaccine
Author(s) -
Tabor Edward,
Barker Lewellys F.,
Gerety Robert J.
Publication year - 1980
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.1890060403
Subject(s) - virology , hepatitis a virus , hepatitis b virus , medicine , hepatitis , hepatitis a , virus , biology
Abstract One hundred milliliters of an inactivated hepatitis B vaccine (20 /m̈g/ml) were inoculated intravenously into two colony‐born infant chimpanzees. Immediately thereafter each received hepatitis B virus from a documented infectious inoculum intravenously at a separate site. Neither chimpanzee developed elevation of aminotransferase levels, hepatitis B surface antigen (HBsAg), or antibody to hepatitis B core antigen during six months of evaluation, the duration of the currently recommended safety test. Both chimpanzees developed antibody to HBsAg beginning 8 and 9 weeks, respectively, after inoculation. The administration of a large intravenous quantity of vaccine antigen thus appeared capable of masking or preventing infection by simultaneously administered hepatitis B virus. This study suggests that a chimpanzee safety test for hepatitis B vaccine should not employ large quantities of vaccine antigen, since such a safety test may fail to detect small amounts of residual infectious hepatitis B virus.

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