# RFA-IP-22-004, Multidisciplinary Approach to Understanding Vaccine Efficacy and Transmission of Viral Respiratory Tract Infections in the Real World

> **NIH ALLCDC U01** · WASHINGTON UNIVERSITY · 2024 · $1,900,000

## Abstract

PROJECT SUMMARY/ABSTRACT – COMPONENT A
Influenza and SARS-CoV-2 are major causes of morbidity and mortality and constitute the leading
causes of vaccine preventable deaths in the United States. A better understanding of vaccine
effectiveness for these viral pathogens is critical to drive public health decisions and interventions. We
propose utilizing a multidisciplinary approach to conduct a test-negative study to determine influenza
and SARS-CoV-2 vaccine effectiveness in ambulatory patients with respiratory tract infections. The
team of investigators includes experts in emergency medicine, infectious disease, pediatrics,
epidemiology, information technology, molecular microbiology, virology, and genetics. This team has
extensive experience in automated electronic medical record alerts, high-volume subject recruitment
of ambulatory patients with respiratory tract infections, rapid escalation/de-escalation of recruitment
efforts to match viral circulation patterns, respiratory and blood sample processing and shipment,
quality data collection and verification, and viral genomic sequencing necessary to ensure the success
of this project. The proposed study will encompass the following specific aims: 1)Utilize innovative
automated alerting strategies to identify and recruit a diverse population of ambulatory patients with
acute respiratory illnesses; 2) Estimate influenza and SARS-CoV-2 vaccine effectiveness using a test-
negative study design in the general population as well as different demographic subgroups.; 3) Explore
factors that influence influenza and SARS-CoV-2 vaccine effectiveness such as co-morbidities,
vaccination type and schedule, and social determinants of health; 4) Determine effect of viral
vaccination status on health outcomes in ambulatory patients with influenza and SARS-CoV-2 infection;
5) Contribute biospecimens and viral genomic sequencing data to a national repository of subjects with
PCR-confirmed influenza or SARS-CoV-2 infection. To accomplish these goals, we will enroll at least
1000 ambulatory patients/year with acute respiratory tract infections in the proposed study. The subject
population will be identified from the emergency departments of 3 large hospitals in the St. Louis area
and their associated outpatient clinics. The available patient population at these enrolling sites is
diverse with respect to race, ethnicity, age, socioeconomic status, and medical care access which will
enhance the generalizability of the study outcomes to the US population.

## Key facts

- **NIH application ID:** 10909767
- **Project number:** 5U01IP001182-03
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Stacey House
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2024
- **Award amount:** $1,900,000
- **Award type:** 5
- **Project period:** 2022-09-30 → 2027-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10909767

## Citation

> US National Institutes of Health, RePORTER application 10909767, RFA-IP-22-004, Multidisciplinary Approach to Understanding Vaccine Efficacy and Transmission of Viral Respiratory Tract Infections in the Real World (5U01IP001182-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10909767. Licensed CC0.

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