Stokes William, Srinivas Geetha, McFarland Richard, Kulpa-Eddy Jodie, Casey Warren, Walker Angela, Draayer Hans, Sebring Randy, Brown Karen, Balks Elisabeth, Stirling Catrina, Klaasen Eric, Hill Richard, Rippke Byron, Ruby Kevin, Alt David, Mukhopadhyay Suman, Kojima Hajime, Johnson Nelson, Rinckel Lori, Doelling Vivian, Jones Brett
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.
Biologicals. 2013 Sep;41(5):279-94. doi: 10.1016/j.biologicals.2013.06.013. Epub 2013 Jul 23.
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.
钩端螺旋体疫苗的常规效力测试大多采用接种-攻毒试验，该试验需要大量仓鼠，会给仓鼠带来持续的疼痛和痛苦。美国国立毒理学研究中心（NICEATM）、国际实验动物管理评估与认可委员会（ICCVAM）及其国际合作伙伴组织了一次研讨会，以审查替代方法的科学现状，这些方法可能会替代、减少和优化在兽医钩端螺旋体疫苗效力测试中使用动物的情况，并确定推进改进替代方法的途径。鼓励疫苗制造商启动或继续使用体外酶联免疫吸附测定法进行特定产品验证，以替代四种常见钩端螺旋体血清群的效力测试。与会者讨论了在仓鼠攻毒试验中取消回滴程序的可能性，这可使每次个体效力测试的动物使用量减少50%。通过使用冷冻保存的钩端螺旋体菌株替代在仓鼠中连续传代，也可能进一步减少动物使用量。血清学检测被确定为进一步减少和优化动物使用的一种方法，但应在尝试体外检测之后再考虑使用。研讨会与会者鼓励在使用仓鼠接种-攻毒效力试验时考虑使用镇痛药，并采用更早的人道终点。建议对替代效力方法进行国际协调，以避免为满足不同地区的要求而进行重复的效力测试。
