Tabor E, Barker L F, Gerety R J
J Med Virol. 1981;6(4):279-84. doi: 10.1002/jmv.1890060403.
One hundred milliliters of an inactivated hepatitis B vaccine (20 microgram/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.
将100毫升灭活乙肝疫苗（20微克/毫升）静脉注射到两只圈养出生的幼年黑猩猩体内。此后，立即在不同部位分别给每只黑猩猩静脉注射来自有记录的感染性接种物的乙肝病毒。在为期6个月的评估（即当前推荐的安全测试时长）期间，两只黑猩猩的转氨酶水平、乙肝表面抗原（HBsAg）或乙肝核心抗原抗体均未升高。两只黑猩猩分别在接种后8周和9周开始产生抗HBsAg抗体。因此，静脉注射大量疫苗抗原似乎能够通过同时接种的乙肝病毒掩盖或预防感染。这项研究表明，乙肝疫苗的黑猩猩安全测试不应使用大量疫苗抗原，因为这样的安全测试可能无法检测到少量残留的感染性乙肝病毒。
