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通过更好的临床前模型提高成功临床结果的机会。

Improving chances for successful clinical outcomes with better preclinical models.

机构信息

PATH, Washington, DC, United States.

Walter Reed Army Institute of Research, Silver Spring, MD, United States.

出版信息

Vaccine. 2017 Dec 14;35(49 Pt A):6798-6802. doi: 10.1016/j.vaccine.2017.08.030. Epub 2017 Sep 7.

DOI:10.1016/j.vaccine.2017.08.030
PMID:28890194
Abstract

In order to avoid expensive clinical failures, better and more predictive animal models of vaccine efficacy are needed to screen Shigella and ETEC vaccine candidates for protective efficacy. The 2016 Vaccines Against Shigella and ETEC (VASE) Conference included a workshop focused on the strengths and weaknesses of current models, particularly in terms of the correlation to vaccine efficacy in human clinical trials. Workshop presenters shared information on existing preclinical animal models for assessing the immunogenicity and protective efficacy of Shigella and ETEC vaccines. The presentations were followed by a discussion about how to best utilize these models, how the models can be improved, and best practices for Shigella and ETEC vaccine developers. The workshop concluded with three major recommendations for the field: (1) develop better and more consistent reagents for animal studies and make them widely available, (2) prioritize harmonization of animal models and immunology assays, and (3) develop preclinical correlates of protection, which will be key in selecting the best vaccine candidates for further clinical development.

摘要

为了避免昂贵的临床失败,需要更好、更具预测性的疫苗功效动物模型来筛选志贺氏菌和肠产毒性大肠杆菌疫苗候选物的保护功效。2016 年抗志贺氏菌和肠产毒性大肠杆菌疫苗会议(VASE)包括一个重点关注当前模型的优缺点的研讨会,特别是在与人体临床试验中疫苗功效的相关性方面。研讨会的演讲者分享了评估志贺氏菌和肠产毒性大肠杆菌疫苗免疫原性和保护功效的现有临床前动物模型的信息。演讲之后,进行了一场关于如何最好地利用这些模型、如何改进模型以及志贺氏菌和肠产毒性大肠杆菌疫苗开发者的最佳实践的讨论。研讨会最后为该领域提出了三项主要建议:(1)开发更好、更一致的动物研究试剂,并广泛提供这些试剂;(2)优先协调动物模型和免疫学检测;(3)开发保护的临床前相关性,这将是选择最佳疫苗候选物进行进一步临床开发的关键。

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Improving chances for successful clinical outcomes with better preclinical models.通过更好的临床前模型提高成功临床结果的机会。
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