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 杜克大学很高兴回应RFA-IP-22-004题为“美国平台，以衡量有效性， 季节性流感、COVID-19及其他呼吸道病毒疫苗，以预防香港的急性疾病 门诊设置”提交申请的组成部分B。杜克大学将协调 疾病控制和预防中心呼吸道病毒疫苗有效性网络的活动 整合科学、项目管理、监管、数据管理的集体广度， 杜克人类疫苗研究所（DHVI）的统计和信息技术专业知识。我们尤其 我们将利用我们之前为NIAID和CDC协调临床研究的丰富经验， 为该项目的工作提供便利。杜克网络协调中心（NCC）将提供后勤和 通过主办视频会议和面对面会议促进网络通信，协调支助， 托管网络SharePoint，提供报告和项目更新，并建立明确的沟通 网络活动计划。作为NCC，DHVI将帮助促进协议的制定和建立 网络调查的标准操作程序。研究将包括对两种流感的评估 和SARS-CoV-2疫苗在社区预防有症状呼吸道感染的有效性， 家庭环境。作为NCC，DHVI也准备好支持评估疫苗的网络研究 免疫原性除了使用更复杂的病毒学和免疫学流感测定的研究外， 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要求。 通过我们既定的质量管理计划，我们还将确保网络研究 以符合药物临床试验质量管理规范的方式进行。杜克NCC将提供数据管理 和网络研究的统计支持。杜克将建立和托管项目特定的REDCap数据库， 这些信息可以容易地导出以通过仪表板提供项目更新。数据输出将 还可用于编写报告、演示文稿和手稿，以传播有关 考虑到传播的病毒株，正在评价的呼吸道病毒疫苗的当前有效性，或 变体。

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.