Department of Pathology, University of Texas Medical Branch, Galveston, TX 77555, USA; Galveston National Laboratory, Galveston, TX 77555, USA; These authors contributed equally to this work.
Department of Pathology, University of Texas Medical Branch, Galveston, TX 77555, USA; Department Microbiology & Immunology, University of Texas Medical Branch, Galveston, TX 77555, USA; Galveston National Laboratory, Galveston, TX 77555, USA.
Trends Microbiol. 2019 Jan;27(1):8-16. doi: 10.1016/j.tim.2018.08.008. Epub 2018 Sep 7.
Testing vaccine efficacy against the highly lethal Ebola virus (EBOV) in humans is almost impossible due to obvious ethical reasons and the sporadic nature of outbreaks. For such situations, the 'animal rule' was established, requiring the product be tested in animal models, expected to predict the response observed in humans. For vaccines, this testing aims to identify immune correlates of protection, such as antibody or cell-mediated responses. In the wake of the 2013-2016 EBOV epidemic, and despite advancement of promising candidates into clinical trials, protective correlates remain ambiguous. In the hope of identifying a reliable correlate by comparing preclinical and clinical trial data on immune responses to vaccination, we conclude that correlates are not universal for all EBOV vaccines.
在人类中测试针对高度致命的埃博拉病毒（EBOV）的疫苗效力几乎是不可能的，这主要是出于明显的伦理原因和疫情的偶发性。出于这种情况，制定了“动物规则”，要求在动物模型中测试产品，预计该产品能够预测人类的反应。对于疫苗，这种测试旨在确定免疫保护相关因素，例如抗体或细胞介导的反应。在 2013-2016 年埃博拉疫情之后，尽管有有前途的候选疫苗进入临床试验，但保护相关因素仍然不明确。为了通过比较疫苗接种后免疫反应的临床前和临床试验数据来确定可靠的相关性，我们得出的结论是，对于所有 EBOV 疫苗，相关性并非普遍适用。
