Kulpa-Eddy Jodie, Srinivas Geetha, Halder Marlies, Hill Richard, Brown Karen, Roth James, Draayer Hans, Galvin Jeffrey, Claassen Ivo, Gifford Glen, Woodland Ralph, Doelling Vivian, Jones Brett, Stokes William S
United States Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Riverdale, Maryland, USA.
United States Department of Agriculture, Animal and Plant Health Inspection Service, Center for Veterinary Biologics, Ames, Iowa, USA.
Procedia Vaccinol. 2011;5:60-83. doi: 10.1016/j.provac.2011.10.005. Epub 2011 Dec 23.
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, ., ., 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 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 methods for veterinary vaccine potency testing that will benefit animal welfare and replace animal use while ensuring continued protection of human and animal health.
美国国立毒理学研究中心替代方法和动物模型验证机构(NICEATM)与美国国立卫生研究院实验动物管理和使用委员会(ICCVAM)联合举办了一次国际研讨会,以审查人类和兽用疫苗效力及安全性检测方法的科学现状,并确定推进新的和改进方法的机会,从而进一步减少、优化和替代动物使用。演讲者和研讨会参与者详细讨论了六个主题,并形成了一系列六份报告。本研讨会报告是该系列中的第二份,为兽用疫苗效力检测中当前和未来非动物方法的使用及策略提供了建议。研讨会参与者建议,未来替代动物使用的工作应优先关注以下疫苗:(1)每次检测使用大量动物且每年生产多个批次的疫苗;(2)在操作过程中会给动物带来巨大疼痛和痛苦的疫苗;(3)已确定功能性保护性抗原的疫苗;(4)涉及对人类有危险的外来动物/人畜共患病原体的疫苗;(5)涉及可轻易传播至野生动物种群的病原体的疫苗。被确定为最优先的疫苗是狂犬病、……、丹毒、外来动物疾病(FAD)、家禽疾病和鱼类疾病的疫苗。对兽用疫苗中保护性抗原的鉴定、纯化和特性研究也被确定为优先事项。研讨会参与者建议开展优先研究、开发和验证活动,以填补关键知识和数据空白,包括应用新科学和技术的机会。建议包括:(1)研究各种佐剂对抗原定量检测的相对影响;(2)研究可用于含有可能干扰抗原检测的佐剂的疫苗的提取方法;(3)审查狂犬病和破伤风人用疫苗效力检测方法的现状,以探讨其应用于相应兽用疫苗的可能性。研讨会参与者建议加强国际协调与合作,以及人类和兽医学研究人员之间更紧密的协作,以加快进展。预计实施研讨会的建议将推动兽用疫苗效力检测替代方法的发展,这将有利于动物福利,替代动物使用,同时确保持续保护人类和动物健康。