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. 2011:5:16-32.
doi: 10.1016/j.provac.2011.10.002. Epub 2011 Dec 23.

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

Richard McFarland  1 , Daniela Verthelyi  2 , Warren Casey  3 , Juan Arciniega  1 , Richard Isbrucker  4 , Michael Schmitt  1 , Theresa Finn  1 , Johan Descamps  5 , Yoshinobu Horiuchi  6 , Dorothea Sesardic  7 , Paul Stickings  7 , Nelson W Johnson  8 , Elizabeth Lipscomb  8 , David Allen  8
Affiliations

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

Richard McFarland 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. This report addresses methods and strategies identified by workshop participants for replacement of animals used for potency testing of human vaccines. Vaccines considered to have the highest priority for future efforts were (1) vaccines for which antigen quantification methods are already developed but not validated, (2) vaccines/components that require the largest number of animals, (3) vaccines that require an in vivo challenge test, and (4) vaccines with in vivo tests that are highly variable and cause a significant number of invalid tests. Vaccine potency tests identified as the highest priorities for replacement were those for diphtheria and tetanus, pertussis (whole cell and acellular), rabies, anthrax, polio vaccine (inactivated) and complex combination vaccines based on DT or DTwP/aP. Research into understanding the precise mechanism of protection afforded by vaccines and the identification of clinically relevant immunological markers are needed to facilitate the successful implementation of in vitro testing alternatives. This report also identifies several priority human vaccines and associated research objectives that are necessary to successfully implement in vitro vaccine potency testing alternatives.

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

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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.
    1. Stokes W.S., Kulpa-Eddy J., McFarland R.M. Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:1–15.
    1. McFarland R., Verthelyi D., Casey W., Arciniega J., Isbrucker R., Schmitt M., Finn T., Descamps J., Horiuchi Y., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:16–32. - PMC - PubMed
    1. Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Roth J., Draayer H., Galvin J., Claassen I., Gifford G., WoodlandR, 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
    1. Casey W., Schmitt M., McFarland R., Isbrucker R., Levis R., Arciniega J., Descamps J., Finn T., Hendriksen C., Horiuchi Y., Keller J., Kojima H., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:33–46. - PMC - PubMed

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