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布鲁里溃疡人体模型：一项对照人体感染研究的临时方案。

A human model of Buruli ulcer: Provisional protocol for a controlled human infection study.

作者信息

Muhi Stephen, Marshall Julia L, O'Brien Daniel P, Johnson Paul D R, Ross Gayle, Ramakrishnan Anand, Mackay Laura K, Doerflinger Marcel, McCarthy James S, Jamrozik Euzebiusz, Osowicki Joshua, Stinear Timothy P

机构信息

Department of Microbiology and Immunology, Doherty Institute, University of Melbourne, Melbourne, Victoria, 3000, Australia.

Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia.

出版信息

Wellcome Open Res. 2024 Oct 21;9:488. doi: 10.12688/wellcomeopenres.22719.1. eCollection 2024.

DOI:10.12688/wellcomeopenres.22719.1
PMID:39386965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11462124/
Abstract

Critical knowledge gaps have impeded progress towards reducing the global burden of disease due to , the cause of the neglected tropical disease Buruli ulcer (BU). Development of a controlled human infection model of BU has been proposed as an experimental platform to explore host-pathogen interactions and evaluate tools for prevention, diagnosis, and treatment. We have previously introduced the use case for a new human model and identified JKD8049 as a suitable challenge strain. Here, we present a provisional protocol for an initial study, for transparent peer review during the earliest stages of protocol development. Following simultaneous scientific peer review and community/stakeholder consultation of this provisional protocol, we aim to present a refined protocol for institutional review board (IRB) evaluation.

摘要

关键的知识空白阻碍了在减轻由[病原体名称]引起的全球疾病负担方面所取得的进展，[病原体名称]是被忽视的热带病布鲁里溃疡（BU）的病因。有人提议开发一种布鲁里溃疡的可控人类感染模型，作为一个实验平台，以探索宿主与病原体的相互作用，并评估预防、诊断和治疗工具。我们之前介绍了一种新的人类模型的应用案例，并确定JKD8049为合适的攻击菌株。在此，我们提出了一项初步研究的临时方案，以便在方案制定的最早阶段进行透明的同行评审。在对该临时方案进行科学同行评审和社区/利益相关者协商之后，我们旨在提出一份完善的方案，供机构审查委员会（IRB）评估。

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