title: A sensitive in vitro assay for the detection of residual viable rabies virus in inactivated rabies vaccines.
abstract: 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 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 vitro assay was 5.7 times that of the in vivo suckling mouse assay, with a detection limit of one focus forming units per ml of test sample. This newly developed in vitro assay may replace the established in vivo suckling mouse assay for confirming viral vaccine inactivation.
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan. Electronic address: mutsuito@nih.go.jp.
authors: Mutsuyo
authors: M
authors: Takayama-Ito
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Kazuo
authors: K
authors: Nakamichi
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Hitomi
authors: H
authors: Kinoshita
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Satsuki
authors: S
authors: Kakiuchi
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Ichiro
authors: I
authors: Kurane
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Masayuki
authors: M
authors: Saijo
authors: Department of Virology 1, National institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan.
authors: Chang-Kweng
authors: CK
authors: Lim
mesh_terms: D000818:Animals; D000833:Animals, Suckling; D002460:Cell Line; D006224:Cricetinae; D006801:Humans; D066298:In Vitro Techniques; D051379:Mice; D011819:Rabies Vaccines / Q000737:chemistry*; D015164:Vaccines, Inactivated / Q000737:chemistry*
chemical_list: D011819:Rabies Vaccines; D015164:Vaccines, Inactivated
keywords: Inactivated rabies vaccine; Inactivation test; Replacement; Vaccine quality control