Failure to detect infectious hepatitis b virus using high dose safety test for hepatitis b vaccine

✍ Scribed by Edward Tabor; Lewellys F. Barker; Robert J. Gerety

• Publisher: John Wiley and Sons
• Year: 1980
• Tongue: English
• Weight: 367 KB
• Volume: 6
• Category: Article
• ISSN: 0146-6615
• DOI: 10.1002/jmv.1890060403

✦ Synopsis

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.