# 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

> **NIH ALLCDC U01** · DUKE UNIVERSITY · 2024 · $750,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10908244
- **Project number:** 5U01IP001194-03
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** EMMANUEL B WALTER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2024
- **Award amount:** $750,000
- **Award type:** 5
- **Project period:** 2022-09-30 → 2025-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908244

## Citation

> US National Institutes of Health, RePORTER application 10908244, 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 (5U01IP001194-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10908244. Licensed CC0.

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