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Sensitive Procedure for Detecting Residual Viable Virus in Inactivated Rabies Vaccine

机译：检测灭活狂犬病疫苗中残留活病毒的灵敏程序

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A procedure for testing inactivated rabies vaccines of tissue culture origin for residual viable virus is reported in which the vaccine to be tested is passed in primary hamster kidney cell culture (PHK) before mouse inoculation. In preliminary experiments, titrations of rabies virus in which each dilution was passed in PHK before inoculating mice yielded titers 100 to 10,000 times higher than the titers obtained for the same virus by direct mouse inoculation. This rabies virus amplification procedure was evaluated by testing 18 lots of inactivated rabies vaccine of tissue culture origin. No viable virus was found in these vaccine lots when tested by direct intracerebral inoculation of mice. Eight of these 18 lots were found to contain viable virus, however, when tested by passage in PHK cell culture. The significance of low levels of viable virus in rabies vaccines is discussed. It is recommended that the amplification procedure described in this report be used in the safety testing of rabies vaccines of tissue culture origin and that it be evaluated for use in testing other rabies vaccines of low tissue content.
机译：据报道，有一种检测组织培养来源的灭活狂犬病疫苗残留活性病毒的方法，其中待检测的疫苗在小鼠接种前先在仓鼠肾细胞培养（PHK）中通过。在初步实验中，滴定狂犬病病毒的滴度比通过直接小鼠接种获得的相同病毒的滴度高100到10,000倍，滴度在接种小鼠之前在PHK中通过。通过测试18批次组织培养来源的灭活狂犬病疫苗，评估了这种狂犬病病毒扩增程序。通过直接脑内接种小鼠进行测试时，在这些疫苗批次中没有发现活病毒。然而，当通过PHK细胞培养传代测试时，发现这18个批次中有8个含有活病毒。讨论了狂犬病疫苗中低水平的活病毒的重要性。建议将本报告中描述的扩增程序用于组织培养起源的狂犬病疫苗的安全性测试，并建议对其进行评估以测试其他低组织含量的狂犬病疫苗。

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