Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
The Task Force for Global Health, Decatur, Georgia, USA.
Influenza Other Respir Viruses. 2024 Oct;18(10):e13358. doi: 10.1111/irv.13358.
On November 13-14, 2023, the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the Task Force for Global Health, Flu Lab, the Canadian Institutes of Health Research, and the Centers for Disease Control and Prevention convened a meeting on controlled human influenza virus infection model (CHIVIM) studies to review the current research landscape of CHIVIM studies and to generate actionable next steps. Presentations and panel discussions highlighted CHIVIM use cases, regulatory and ethical considerations, innovations, networks and standardization, and the utility of using CHIVIM in vaccine development. This report summarizes the presentations, discussions, key takeaways, and future directions for innovations in CHIVIMs. Experts agreed that CHIVIM studies can be valuable for the study of influenza infection, immune response, and transmission. Furthermore, they may have utility in the development of vaccines and other medical countermeasures; however, the use of CHIVIMs to de-risk clinical development of investigational vaccines should employ a cautious approach. Endpoints in CHIVIM studies should be tailored to the specific use case. CHIVIM studies can provide useful supporting data for vaccine licensure but are not required and do not obviate the need for the conduct of field efficacy trials. Future directions in this field include the continued expansion of capacity to conduct CHIVIM studies, development of a broad panel of challenge viruses and assay reagents and standards that can be shared, streamlining of manufacturing processes, the exploration of targeted delivery of virus to the lower respiratory tract, efforts to more closely replicate natural influenza disease in CHIVIM, alignment on a definition of breadth to facilitate development of more broadly protective/universal vaccine approaches, and continued collaboration between stakeholders.
2023 年 11 月 13 日至 14 日，过敏和传染病研究所（NIAID）与全球卫生工作队、流感实验室、加拿大卫生研究院和疾病控制与预防中心合作，召开了一次关于受控人流感病毒感染模型（CHIVIM）研究的会议，以审查 CHIVIM 研究的当前研究现状，并制定可行的下一步措施。演示文稿和小组讨论强调了 CHIVIM 的使用案例、监管和伦理考虑因素、创新、网络和标准化，以及在疫苗开发中使用 CHIVIM 的效用。本报告总结了演示文稿、讨论、主要收获以及 CHIVIM 创新的未来方向。专家们一致认为，CHIVIM 研究对于流感感染、免疫反应和传播的研究具有重要价值。此外，它们在疫苗和其他医疗对策的开发中可能具有实用性；然而，为降低研究性疫苗的临床开发风险而使用 CHIVIM 应采取谨慎的方法。CHIVIM 研究中的终点应根据具体的使用情况进行调整。CHIVIM 研究可为疫苗许可提供有用的支持数据，但并非必需，也不能免除进行现场疗效试验的必要性。该领域的未来方向包括继续扩大进行 CHIVIM 研究的能力，开发广泛的挑战病毒和检测试剂以及可以共享的标准，简化制造工艺，探索将病毒靶向递送至下呼吸道，努力更密切地在 CHIVIM 中复制自然流感疾病，对齐广度定义以促进更广泛保护/通用疫苗方法的开发，以及利益相关者之间的持续合作。
