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The rat-based neurovirulence safety test for the assessment of mumps virus neurovirulence in humans: an international collaborative study. 2005

Steven A Rubin, and Muhammad A Afzal, and Caroline L Powell, and Maureen L Bentley, and Ghazi R Auda, and Rolf E Taffs, and Kathryn M Carbone
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Adminstration, Bethesda, Maryland 20892, USA. rubins@cber.fda.gov

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.

UI MeSH Term Description Entries
D009108 Mumps Vaccine Vaccines used to prevent infection by MUMPS VIRUS. Best known is the live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine. Inactivated Mumps Vaccine,Inactivated Mumps Virus Vaccine,Live Attenuated Mumps Vaccine,Live Attenuated Mumps Virus Vaccine,Mumps Vaccine, Inactivated,Mumps Vaccine, Live Attenuated,Mumps Virus Vaccine, Inactivated,Mumps Virus Vaccine, Live Attenuated,Vaccine, Inactivated Mumps,Vaccine, Mumps
D009109 Mumps virus The type species of RUBULAVIRUS that causes an acute infectious disease in humans, affecting mainly children. Transmission occurs by droplet infection. Epidemic Parotitis Virus,Myxovirus parotitidis,Epidemic Parotitis Viruses,Mumps viruses
D001921 Brain The part of CENTRAL NERVOUS SYSTEM that is contained within the skull (CRANIUM). Arising from the NEURAL TUBE, the embryonic brain is comprised of three major parts including PROSENCEPHALON (the forebrain); MESENCEPHALON (the midbrain); and RHOMBENCEPHALON (the hindbrain). The developed brain consists of CEREBRUM; CEREBELLUM; and other structures in the BRAIN STEM. Encephalon
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D014773 Virology The study of the structure, growth, function, genetics, and reproduction of viruses, and VIRUS DISEASES.
D014774 Virulence The degree of pathogenicity within a group or species of microorganisms or viruses as indicated by case fatality rates and/or the ability of the organism to invade the tissues of the host. The pathogenic capacity of an organism is determined by its VIRULENCE FACTORS. Pathogenicity
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D051381 Rats The common name for the genus Rattus. Rattus,Rats, Laboratory,Rats, Norway,Rattus norvegicus,Laboratory Rat,Laboratory Rats,Norway Rat,Norway Rats,Rat,Rat, Laboratory,Rat, Norway,norvegicus, Rattus

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