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Report on the international workshop on alternative methods for Leptospira vaccine potency testing: State of the science and the way forward |
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| Authors: | William Stokes Geetha Srinivas Richard McFarland Jodie Kulpa-Eddy Warren Casey Angela Walker Hans Draayer Randy Sebring Karen Brown Elisabeth Balks Catrina Stirling Eric Klaasen Richard Hill Byron Rippke Kevin Ruby David Alt Suman Mukhopadhyay Hajime Kojima Brett Jones |
| Institution: | 1. National Toxicology Program Interagency Center for The Evaluation of Alternative Toxicological Methods (NICEATM), Division of The National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, MD:K2-16, Research Triangle Park, NC 27709, USA;2. Center for Veterinary Biologics, U.S. Department of Agriculture (USDA), P.O Box 844, Ames, IA 50010, USA;3. Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 1401 Rockville Pike, HFM-700, Rockville, MD 20852, USA;4. USDA Animal and Plant Health Inspection Service, 4700 River Road, Unit 2, Riverdale, MD 20737, USA;5. Gourdneck View Consulting, LLC, Portage, MI 49002, USA;6. Colorado Serum Company, 4950 York Street, P.O. Box 16428, Denver, CO 80216, USA;7. Pair O''Docs Consultants, 5501 N.W. Foxhill Road, Parkville, MO 64152, USA;8. Paul-Ehrlich-Institut, Paul-Ehrlich-Institut-Strasse 51-59, 63225 Langen, Germany;9. Pfizer Ltd., Ramsgate Road, Sandwich, Kent CT13 9NJ, UK;10. MSD Animal Health, P.O. Box 31, 5830 AA Boxmeer, The Netherlands;11. USDA Agricultural Research Service, 1920 Dayton Ave, Ames, IA 50010, USA;12. Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, 6610 Rockledge Drive, Bethesda, MD 20892, USA;13. Japanese Center for The Validation of Alternative Methods, National Institute of Health Sciences, Kamiyoga 1-18-1, Setagaya-ku, 158-5801 Tokyo, Japan;14. Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA |
| Abstract: | Routine potency testing of Leptospira vaccines is mostly conducted using a vaccination–challenge test that involves large numbers of hamsters and unrelieved pain and distress. NICEATM, ICCVAM, and their international partners organized a workshop to review the state of the science of alternative methods that might replace, reduce, and refine the use of animals for veterinary Leptospira vaccine potency testing and to identify ways to advance improved alternative methods. Vaccine manufacturers were encouraged to initiate or continue product-specific validation using in vitro enzyme-linked immunosorbent assays as replacements for potency testing of four common Leptospira serogroups. Participants discussed the potential for eliminating the back-titration procedure in the hamster challenge assay, which could reduce animal use by 50% for each individual potency test. Further animal reduction may also be possible by using cryopreserved Leptospira stock to replace continual passaging through hamsters. Serology assays were identified as a way to further reduce and refine animal use but should be considered only after attempting in vitro assays. Workshop participants encouraged consideration of analgesics and use of earlier humane endpoints when the hamster vaccination–challenge potency assay is used. International harmonization of alternative potency methods was recommended to avoid duplicative potency testing to meet regionally different requirements. |
| Keywords: | Alternative methods Potency Replacement Refinement Reduction |
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