What Is the Predictive Value of Animal Models for Vaccine Efficacy in Humans? The Importance of Bridging Studies and Species-Independent Correlates of Protection
What Is the Predictive Value of Animal Models for Vaccine Efficacy in Humans? The Importance of Bridging Studies and Species-Independent Correlates of Protection
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DOI：
10.1101/cshperspect.a028902
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发表时间：
2018-04-01
影响因子：
7.2
通讯作者：
Zaitseva, Marina
中科院分区：
文献类型：
--
作者：
Golding, Hana;Khurana, Surender;Zaitseva, Marina
动物模型在疫苗研发的所有阶段都发挥了关键作用。它们对疫苗有效性的预测价值取决于病原体、动物挑战模型的稳健性和保护的相关性(如果已知)。这篇文章将涵盖有关将动物研究与人体疗效试验联系起来的关键问题。例如，人乳头瘤病毒(HPV)疫苗在接种异种原型病毒样颗粒(VLP)后进行动物保护，预测了在人类身上成功的疗效试验，以及最近根据“动物规则”批准的炭疽疫苗。到目前为止，预测人类疫苗有效性的动物模型的建立充满了困难，成功率很低。将讨论使用动物模型开发埃博拉和艾滋病毒疫苗所面临的挑战。
Animal models have played a pivotal role in all stages of vaccine development. Their predictive value for vaccine effectiveness depends on the pathogen, the robustness of the animal challenge model, and the correlates of protection (if known). This article will cover key questions regarding bridging animal studies to efficacy trials in humans. Examples include human papillomavirus (HPV) vaccine in which animal protection after vaccination with heterologous prototype virus-like particles (VLPs) predicted successful efficacy trials in humans, and a recent approval of anthrax vaccine in accordance with the "Animal Rule." The establishment of animal models predictive of vaccine effectiveness in humans has been fraught with difficulties with low success rate to date. Challenges facing the use of animal models for vaccine development against Ebola and HIV will be discussed.