# Annual Estimates of Influenza Vaccine Effectiveness and Evaluation of Immune Response in a Wisconsin Population

> **NIH ALLCDC U01** · MARSHFIELD CLINIC, INC. · 2020 · $1,800,000

## Abstract

Project Summary/Abstract - Core and Additional Components
Influenza, an important cause of morbidity and mortality, and influenza vaccination are key
components of influenza prevention. The effectiveness of influenza vaccine varies from year to
year, and it can vary by virus subtype, age group, product type, population characteristics, and
antigenic match. Annual assessment of clinical vaccine effectiveness is therefore needed to
evaluate the impact of current vaccine recommendations and policies, understand the
relationship between antigenic changes in viruses and clinical protection, and prepare for
vaccine assessment during a pandemic. Interim, mid-season estimates of vaccine effectiveness
are useful for public health agencies and physicians. The first Aim of the project is to estimate
the effectiveness of influenza vaccine for preventing medically-attended, laboratory confirmed
influenza illness in a defined population cohort of adults and children. Patients who seek
outpatient care for acute respiratory illness will be recruited during the influenza season.
Patients with cough and illness duration ≤7 days will be eligible. After informed consent, nose
and throat swabs will be tested for influenza A and B using a nucleic acid amplification test (RT-
PCR). Samples will be provided to CDC for antigenic characterization and other tests as
appropriate. Influenza immunization status will be determined by a validated immunization
registry. Vaccine effectiveness will be calculated using the test negative design where cases
include participants with RT-PCR confirmed influenza and controls include study participants
with noninfluenza respiratory illness (negative RT-PCR). Data will be provided to CDC for
combined analyses with other participating sites, including mid-season data for interim analysis
of effectiveness. When possible, separate estimates of vaccine effectiveness will be calculated
for different age groups, influenza subtypes, and for different vaccine products. The second Aim
is to evaluate the disease burden due to RSV during the last three seasons of the project.
Participant samples will be tested for RSV using RT-PCR, and the incidence of medically
attended RSV will be estimated. The third Aim is to serve as an emergency response resource
for CDC pandemic studies of vaccination and antivirals. This will include pilot studies to prepare
for a pandemic.

## Key facts

- **NIH application ID:** 9948527
- **Project number:** 5U01IP001038-05
- **Recipient organization:** MARSHFIELD CLINIC, INC.
- **Principal Investigator:** EDWARD BELONGIA
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $1,800,000
- **Award type:** 5
- **Project period:** 2016-08-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9948527

## Citation

> US National Institutes of Health, RePORTER application 9948527, Annual Estimates of Influenza Vaccine Effectiveness and Evaluation of Immune Response in a Wisconsin Population (5U01IP001038-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9948527. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*