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1 April 2005

Volume 191, Number 7
The Journal of Infectious Diseases 2005;191:1123–1128
© 2005 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2005/19107-0015$15.00
DOI: 10.1086/428098
MAJOR ARTICLE

The Rat‐Based Neurovirulence Safety Test for the Assessment of Mumps Virus Neurovirulence in Humans: An International Collaborative Study

Steven A. Rubin,1

Muhammad A. Afzal,4

Caroline L. Powell,4

Maureen L. Bentley,4

Ghazi R. Auda,4

Rolf E. Taffs,2 and

Kathryn M. Carbone3

1Office of Vaccines Research and Review, 2Office of Blood Research and Review, and 3Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Adminstration, Bethesda, Maryland; 4Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Herts, United Kingdom

Because of the highly neurotropic and neurovirulent properties of wild‐type mumps viruses, most national regulatory organizations require neurovirulence testing of virus seeds used in the production of mumps vaccines. Such testing has historically been performed in monkeys; however, some data suggest that testing in monkeys does not necessarily discriminate among the relative neurovirulent risks of mumps virus strains. To address this problem, a collaborative study was initiated by the National Institute for Biological Standards and Control in the United Kingdom and the Food and Drug Administration in the United States, to test a novel rat‐based mumps virus neurovirulence safety test. Results indicate that the assay correctly assesses the neurovirulence potential of mumps viruses in humans and is robust and reproducible.

Received 6 August 2004; accepted 8 October 2004; electronically published 22 February 2005.

Reprints or correspondence: Dr. Steven A. Rubin, DVP/OVRR/CBER/FDA, Bldg. 29A, Rm. 1A‐21, 8800 Rockville Pike, Bethesda, MD 20892 ().

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T. H. Malik, C. Wolbert, L. Nerret, C. Sauder, S. Rubin. (2009) Single amino acid changes in the mumps virus haemagglutinin-neuraminidase and polymerase proteins are associated with neuroattenuation. Journal of General Virology 90:7, 1741-1747
Online publication date: 1-Aug-2009.
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Dion Shah, Silvia Vidal, Malen A. Link, Steven A. Rubin, Kathryn E. Wright. (2009) Identification of genetic mutations associated with attenuation and changes in tropism of Urabe mumps virus. Journal of Medical Virology 81:1, 130-138
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Y. Hrynash, A. Nadraga, M. Dasho. (2009) Effectiveness of a vaccination program against mumps in Ukraine. European Journal of Clinical Microbiology & Infectious Diseases 27:12, 1171-1176
Online publication date: 1-Jan-2009.
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  • Financial support: National Vaccine Program Office, US Department of Health and Human Services.

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