第四次人类感染控制模型(CHIM)会议--流行国家的人类感染控制模型,2023 年 5 月 22-23 日。

IF 1.5 4区 生物学 Q4 BIOCHEMICAL RESEARCH METHODS Biologicals Pub Date : 2024-02-01 Epub Date: 2024-02-13 DOI:10.1016/j.biologicals.2024.101747
Melissa Kapulu , Lucinda Manda-Taylor , Shobana Balasingam , Gary Means , Mikal Ayiro Malungu , Philip Bejon , Primus Che Chi , Christopher Chiu , E. Chandler Church , Rodrigo Correa-Oliveira , Nicholas Day , Anna Durbin , Moses Egesa , Claudia Emerson , Kondwani Jambo , Roli Mathur , Wolfram Metzger , Noni Mumba , Winfred Nazziwa , Ally Olotu , Pieter Neels
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引用次数: 0

摘要

前几次会议为受控人类感染模型(CHIM)(也称为人类挑战研究和人类感染研究)奠定了基础,包括挑战剂的良好生产规范(GMP)生产、CHIM 伦理学、CHIM 中的环境安全、招募、社区参与、广告和激励措施、原有免疫以及临床、免疫学和微生物学终点。第四次 CHIM 会议重点讨论了流行国家正在开展的 CHIM 研究。在过去十年中,我们看到非洲开展 CHIM 研究的国家数量大幅增加,所使用的不同挑战性生物体也越来越多。社区和公众的参与以及严格的伦理和监管监督一直是成功引进的关键,应继续采用更多社区主导或社区驱动的模式。对 CHIMs 的监管已经采取了有价值的举措,但进一步的能力建设仍然至关重要。
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Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023

Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.

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来源期刊
Biologicals
Biologicals 生物-生化研究方法
CiteScore
3.70
自引率
0.00%
发文量
39
审稿时长
48 days
期刊介绍: Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.
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