Colorado State University, Department of Microbiology, Immunology & Pathology, 1682 Campus Delivery, Fort Collins, CO 80523, USA.
Tuberculosis (Edinb). 2012 Jan;92(1):105-11. doi: 10.1016/j.tube.2011.09.003. Epub 2011 Oct 1.
The guinea pig model of tuberculosis is used extensively in different locations to assess the efficacy of novel tuberculosis vaccines during pre-clinical development. Two key assays are used to measure protection against virulent challenge: a 30 day post-infection assessment of mycobacterial burden and long-term post-infection survival and pathology analysis. To determine the consistency and robustness of the guinea pig model for testing vaccines, a comparative assessment between three sites that are currently involved in testing tuberculosis vaccines from external providers was performed. Each site was asked to test two "subunit" type vaccines in their routine animal model as if testing vaccines from a provider. All sites performed a 30 day study, and one site also performed a long-term survival/pathology study. Despite some differences in experimental approach between the sites, such as the origin of the Mycobacterium tuberculosis strain and the type of aerosol exposure device used to infect the animals and the source of the guinea pigs, the data obtained between sites were consistent in regard to the ability of each "vaccine" tested to reduce the mycobacterial burden. The observations also showed that there was good concurrence between the results of short-term and long-term studies. This validation exercise means that efficacy data can be compared between sites.
豚鼠结核病模型广泛应用于不同地区，用于评估新型结核病疫苗在临床前开发阶段的疗效。有两种关键的检测方法用于衡量对强毒力攻击的保护作用：感染后 30 天评估分枝杆菌负荷和长期感染后生存和病理分析。为了确定豚鼠模型在测试疫苗方面的一致性和稳健性，对目前参与从外部供应商测试结核病疫苗的三个地点进行了比较评估。每个地点都被要求在其常规动物模型中测试两种“亚单位”类型的疫苗，就好像在测试来自供应商的疫苗一样。所有地点都进行了 30 天的研究，其中一个地点还进行了长期生存/病理学研究。尽管各地点之间的实验方法存在一些差异，例如结核分枝杆菌菌株的来源和用于感染动物的气溶胶暴露装置的类型以及豚鼠的来源，但各地点之间获得的数据在每种“疫苗”测试降低分枝杆菌负荷的能力方面是一致的。这些观察结果还表明，短期和长期研究的结果具有很好的一致性。这项验证性研究意味着可以比较各地点之间的疗效数据。
