RFA-IP-22-004, US Platform to Measure Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings

摘要-杜克人类疫苗研究所 杜克大学很高兴对RFA-IP-22-004号文件作出回应，该文件的标题是《美国衡量 季节性流感、新冠肺炎等呼吸道病毒疫苗预防急性呼吸道疾病的研究 通过提交B组件的申请来进行“非卧床设置”杜克大学将协调 疾病控制和预防中心呼吸道病毒疫苗效力网络的活动 整合了科学、计划管理、监管、数据管理、 杜克人类疫苗研究所(DHVI)的统计、信息技术专长。特别是，我们 将利用我们为NIAID和CDC协调临床调查的丰富经验来帮助 促进这一项目的工作。杜克大学网络协调中心(NCC)将提供后勤和 通过举办视频和面对面会议来促进网络通信，从而协调支持， 托管网络SharePoint，提供报告和项目更新，并建立清晰的沟通 规划网络活动。作为国家协调委员会，国土安全部将帮助促进议定书的制定和建立 网络调查的标准操作程序。研究将包括对这两种流感的评估 和SARS-CoV-2疫苗预防社区和社区有症状的呼吸道感染的有效性 家居环境。作为NCC，DHVI也做好了支持评估疫苗的网络研究的准备 免疫原性除了使用更复杂的病毒学和免疫流感检测方法进行研究外，还可以 检测流感病毒感染和宿主对感染的免疫反应。与杜克大学合作 卫生系统IRB，杜克NCC将提供监管支持，以促进单一IRB的要求。 通过我们已建立的质量管理计划，我们还将确保网络研究 以符合良好临床实践的方式执行。Duke NCC将提供数据管理 以及对网络研究的统计支持。Duke将构建并托管特定于项目的RedCap数据库 这些信息可以很容易地导出，以通过仪表板提供项目更新。数据导出将 还可用于编写报告、演示文稿和手稿，以传播有关 目前正在评估呼吸道病毒疫苗的有效性，考虑到流行的病毒株或 变种。

ABSTRACT – Duke Human Vaccine Institute Duke University is pleased to respond to RFA-IP-22-004 entitled “US Platform to Measure the Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings” by submitting the application for Component B. Duke University will coordinate the activities of the Centers for Disease Control and Prevention’s Respiratory Virus Vaccine Effectiveness Network incorporating the collective breadth of scientific, program management, regulatory, data management, statistical, and information technology expertise of the Duke Human Vaccine Institute (DHVI). In particular, we will leverage our vast prior experience coordinating clinical investigations for both NIAID and the CDC to help facilitate the work of this project. The Duke Network Coordinating Center (NCC) will provide logistical and coordinating support by facilitating network communications through hosting video and in-person conferences, hosting a network SharePoint, providing reports and project updates and establishing a clear communication plan for network activities. As the NCC, The DHVI will help facilitate protocol development and establish standard operating procedures for network investigations. Studies will include evaluations of both influenza and SARS-CoV-2 vaccine effectiveness at preventing symptomatic respiratory infection in the community and household settings. As the NCC, the DHVI is also well poised to support network studies assessing vaccine immunogenicity in addition to studies using more complex virologic and immunologic influenza assays to detect influenza virus infection and the host immune response to infection. Working with the Duke University Health System IRB, the Duke NCC will provide the regulatory support to facilitate single IRB requirements. Through our established quality management programs, we will also assure that network studies are performed in a manner which adhere to good clinical practice. The Duke NCC will provide data management and statistical support for network studies. Duke will build and host project specific REDCap databases from which information can be readily exported to provide project updates through dashboards. Data exports will also be utilized to create reports, presentations and manuscripts to disseminate information regarding the current effectiveness of the respiratory virus vaccine being evaluated given the circulating virus strains or variants.