The rat-based neurovirulence safety test for the assessment of mumps virus neurovirulence in humans: an international collaborative study.
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.
Rubin
Steven A
SA
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Adminstration, Bethesda, Maryland 20892, USA. rubins@cber.fda.gov
Afzal
Muhammad A
MA
Powell
Caroline L
CL
Bentley
Maureen L
ML
Auda
Ghazi R
GR
Taffs
Rolf E
RE
Carbone
Kathryn M
KM
D000818:Animals; D001921:Brain / Q000473:pathology / Q000821:virology*; D006801:Humans; D009108:Mumps Vaccine / Q000009:adverse effects*; D009109:Mumps virus / Q000472:pathogenicity*; D051381:Rats; D015203:Reproducibility of Results; D014773:Virology / Q000379:methods*; D014774:Virulence
D009108:Mumps Vaccine