Influenza Resource Centre, Vaccines, Science Research & Innovation, Medicines and Healthcare Products Regulatory Agency, Potters Bar, UK.
Influenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway.
Influenza Other Respir Viruses. 2024 Oct;18(10):e70013. doi: 10.1111/irv.70013.
Controlled human infection models (CHIMs) are a critical tool for the understanding of infectious disease progression, characterising immune responses to infection and rapid assessment of vaccines or drug treatments. There is increasing interest in using CHIMs for vaccine development and an obvious need for widely available and fit-for-purpose challenge agents. Inno4Vac is a large European consortium working towards accelerating and de-risking the development of new vaccines, including development of CHIMs for influenza, respiratory syncytial virus and Clostridium difficile. This report (in two parts) summarises a workshop held at the MHRA in 2021, focused on how to select CHIM candidate strains of influenza and respiratory syncytial virus (RSV) based on desirable virus characteristics and which immune assays would provide relevant information for assessing pre-existing and post-infection immune responses and defining correlates of protection. This manuscript (part 2) summarises presentations and discussions centred around RSV CHIMs and immune assays (an additional manuscript summarises influenza CHIM and immune assays: Inno4Vac workshop report Part 1: Controlled human influenza virus infection model (CHIVIM) strain selection and immune assays for CHIVIM studies, November 2021, MHRA, UK).
受控人体感染模型(CHIMs)是理解传染病进展、描述感染后免疫反应以及快速评估疫苗或药物治疗的重要工具。人们对使用 CHIMs 进行疫苗开发越来越感兴趣,并且显然需要广泛可用且适用的挑战剂。Inno4Vac 是一个大型的欧洲联盟,致力于加速和降低新疫苗的开发风险,包括开发流感、呼吸道合胞病毒和艰难梭菌的 CHIMs。本报告(分为两部分)总结了 2021 年在英国药品和保健品管理局(MHRA)举行的一次研讨会,重点讨论了如何根据理想的病毒特性选择流感和呼吸道合胞病毒(RSV)的 CHIM 候选株,以及哪些免疫检测将为评估感染前和感染后免疫反应以及定义保护相关因素提供相关信息。本文(第 2 部分)总结了围绕 RSV CHIM 和免疫检测的演示和讨论(另一篇文章总结了流感 CHIM 和免疫检测:Inno4Vac 研讨会报告第 1 部分:受控人体流感病毒感染模型(CHIVIM)株选择和 CHIVIM 研究的免疫检测,2021 年 11 月,英国 MHRA)。