A sensitive in聽vitro assay for the detection of residual viable rabies virus in inactivated rabies vaccines

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• 作者：Mutsuyo Takayama-Ito ; Kazuo Nakamichi ; Hitomi Kinoshita ; Satsuki Kakiuchi ; Ichiro Kurane ; Masayuki Saijo ; Chang-Kweng Lim
• 关键词：Inactivated rabies vaccine ; Inactivation test ; Replacement ; Vaccine quality control
• 刊名：Biologicals
• 出版年：January, 2014
• 年：2014
• 卷：42
• 期：1
• 页码：42-47
• 全文大小：840 K

文摘

Rabies is a viral disease transmitted through bites from rabid animals and can be prevented by vaccines. Clinically used rabies vaccines are prepared from inactivated rabies viruses grown in cell cultures or embryonated eggs. In Japan and across the world, tests that confirm complete inactivation, such as the in聽vivo suckling mouse assay, in which suckling mice are intracerebrally inoculated with vaccine products, are required for quality control. In this study, we developed a novel cell-based immunofluorescence assay that does not require mice for testing rabies vaccine inactivation for human use. The sensitivity of this cell-based in聽vitro assay was 5.7 times that of the in聽vivo suckling mouse assay, with a detection limit of one focus forming units per ml of test sample. This newly developed in聽vitro assay may replace the established in聽vivo suckling mouse assay for confirming viral vaccine inactivation.