Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: State of the science and planning the way forward
| Autor: | Marlies Halder, Brett Jones, Warren Casey, Timothy J. Miller, Jodie Kulpa-Eddy, Peter S. Wunderli, Karen Brown, David L. Reed, Richard Hill, Vivian W. Doelling, Hajime Kojima, Jean-Michel Chapsal, William S. Stokes, Fabrizio De Mattia, Charles E. Rupprecht, Robin Levis, Lukas Bruckner, Gayle Pulle, Sunil Gairola, Richard McFarland, Nelson W Johnson, Donna M. Gatewood, Lori Rinckel, Koichiro Gamoh, Charles E. Lewis, Alexander Gaydamaka, David J. Allen, Lorraine M. McElhinney, Elisabeth Kamphuis |
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| Rok vydání: | 2012 |
| Předmět: |
Pharmacology
Alternative methods Veterinary medicine General Immunology and Microbiology business.industry education Rabies virus Bioengineering General Medicine medicine.disease_cause medicine.disease Applied Microbiology and Biotechnology Test (assessment) Vaccination Rabies vaccine Medicine Potency Rabies State of the science business Biotechnology medicine.drug |
| Zdroj: | Biologicals. 40:369-381 |
| ISSN: | 1045-1056 |
| Popis: | Potency testing of most human and veterinary rabies vaccines requires vaccination of mice followed by a challenge test using an intracerebral injection of live rabies virus. NICEATM, ICCVAM, and their international partners organized a workshop to review the availability and validation status of alternative methods that might reduce, refine, or replace the use of animals for rabies vaccine potency testing, and to identify research and development efforts to further advance alternative methods. Workshop participants agreed that general anesthesia should be used for intracerebral virus injections and that humane endpoints should be used routinely as the basis for euthanizing animals when conducting the mouse rabies challenge test. Workshop participants recommended as a near-term priority replacement of the mouse challenge with a test validated to ensure potency, such as the mouse antibody serum neutralization test for adjuvanted veterinary rabies vaccines for which an international collaborative study was recently completed. The workshop recommended that an in vitro antigen quantification test should be a high priority for product-specific validation of human and non-adjuvanted veterinary rabies vaccines. Finally, workshop participants recommended greater international cooperation to expedite development, validation, regulatory acceptance, and implementation of alternative test methods for rabies vaccine potency testing. |
| Databáze: | OpenAIRE |
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