Center for Vaccine Innovation and Access, PATH, 455 Massachusetts Avenue NW, Suite 1000, Washington, DC 20001, USA.
Bill & Melinda Gates Foundation, PO Box 23350, Seattle, WA 98102, USA.
Vaccine. 2019 Aug 14;37(35):4830-4834. doi: 10.1016/j.vaccine.2019.06.053.
In response to global interest in the development of a universal influenza vaccine, the Bill & Melinda Gates Foundation, PATH, and the Global Funders Consortium for Universal Influenza Vaccine Development convened a meeting of experts (London, UK, May 2018) to assess the role of a standardized controlled human influenza virus infection model (CHIVIM) towards the development of novel influenza vaccine candidates. This report (in two parts) summarizes those discussions and offers consensus recommendations. Part 1 covers challenge virus selection, regulatory and ethical considerations, and issues concerning standardization, access, and capacity. This article (Part 2) summarizes the discussion and recommendations concerning CHIVIM methods. The panelists identified an overall need for increased standardization of CHIVIM trials, in order to produce comparable results that can support universal vaccine licensure. Areas of discussion included study participant selection and screening, route of exposure and dose, devices for administering challenge, rescue therapy, protection of participants and institutions, clinical outcome measures, and other considerations. The panelists agreed upon specific recommendations to improve the standardization and usefulness of the model for vaccine development. Experts agreed that a research network of institutions working with a standardized CHIVIM could contribute important data to support more rapid development and licensure of novel vaccines capable of providing long-lasting protection against seasonal and pandemic influenza strains.
针对全球对通用流感疫苗开发的关注，比尔及梅琳达·盖茨基金会、PATH 和全球流感疫苗开发者联盟召集了一次专家会议（2018 年 5 月，英国伦敦），以评估标准化的人体受控流感病毒感染模型（CHIVIM）在新型流感疫苗候选物开发中的作用。本报告（分两部分）总结了这些讨论并提出了共识建议。第 1 部分涵盖了挑战病毒选择、监管和伦理考虑以及标准化、准入和能力相关问题。本文（第 2 部分）总结了有关 CHIVIM 方法的讨论和建议。专家组确定了对 CHIVIM 试验进行更多标准化的总体需求，以产生可支持通用疫苗许可的可比结果。讨论的领域包括研究参与者的选择和筛选、暴露途径和剂量、挑战接种设备、救援疗法、参与者和机构的保护、临床结果测量以及其他考虑因素。专家组就改善模型在疫苗开发中的标准化和实用性达成了具体建议。专家们一致认为，一个采用标准化 CHIVIM 的机构研究网络可以提供重要数据，以支持更快速地开发和许可能够对季节性和大流行性流感株提供持久保护的新型疫苗。
