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

RFA-IP-22-004，衡量季节性流感、COVID-19 和其他呼吸道病毒疫苗在流动环境中预防急性疾病有效性的美国平台

• 批准号: 10617500
• 负责人: EMMANUEL B WALTER
• 金额: $ 98.8万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617500
• 关键词: RFA; IP; 22; 004; US

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.

摘要-杜克人类疫苗研究所