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. 2011:5:60-83.
doi: 10.1016/j.provac.2011.10.005. Epub 2011 Dec 23.

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy  1 , Geetha Srinivas  2 , Marlies Halder  3 , Richard Hill  2 , Karen Brown  4 , James Roth  5 , Hans Draayer  6 , Jeffrey Galvin  6 , Ivo Claassen  7 , Glen Gifford  8 , Ralph Woodland  9 , Vivian Doelling  10 , Brett Jones  10 , William S Stokes  11
Affiliations

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy et al. Procedia Vaccinol. 2011.

Abstract

NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Six topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the second in the series, provides recommendations for current and future use of non-animal methods and strategies for veterinary vaccine potency testing. Workshop participants recommended that future efforts to replace animal use give priority to vaccines (1) that use large numbers of animals per test and for which many serials are produced annually, (2) that involve significant animal pain and distress during procedures, (3) for which the functional protective antigen has been identified, (4) that involve foreign animal/zoonotic organisms that are dangerous to humans, and (5) that involve pathogens that can be easily spread to wildlife populations. Vaccines identified as the highest priorities were those for rabies, Leptospira spp., Clostridium spp., Erysipelas, foreign animal diseases (FAD), poultry diseases, and fish diseases. Further research on the identification, purification, and characterization of vaccine protective antigens in veterinary vaccines was also identified as a priority. Workshop participants recommended priority research, development, and validation activities to address critical knowledge and data gaps, including opportunities to apply new science and technology. Recommendations included (1) investigations into the relative impact of various adjuvants on antigen quantification assays, (2) investigations into extraction methods that could be used for vaccines containing adjuvants that can interfere with antigen assays, and (3) review of the current status of rabies and tetanus human vaccine in vitro potency methods for their potential application to the corresponding veterinary vaccines. Workshop participants recommended enhanced international harmonization and cooperation and closer collaborations between human and veterinary researchers to expedite progress. Implementation of the workshop recommendations is expected to advance alternative in vitro methods for veterinary vaccine potency testing that will benefit animal welfare and replace animal use while ensuring continued protection of human and animal health.

Keywords: ICCVAM; replacement alternatives; vaccine potency testing; vaccine safety testing; veterinary vaccines.

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References

    1. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences, 2008. NIH Publication No. 08-6410. http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
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    1. Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Roth J., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B., Stokes W.S. Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:60–83. - PMC - PubMed
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