# US Influenza Vaccine Effectiveness Network

> **NIH ALLCDC U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2020 · $2,999,990

## Abstract

Project Summary Abstract:
Influenza vaccination is the most effective means of preventing influenza virus infection and its more severe
complications. Due to the changing nature of influenza viruses, active surveillance alongside regular updating
of vaccine components and annual vaccination are necessary for vaccine protection. There is a need for
annual evaluation of vaccine effectiveness (VE), which may vary from year to year. These estimates are critical
to inform the medical community, maintain public confidence in the vaccine, and determine the effect of virus
drift on protection. Modern study designs to assess VE require laboratory confirmation of influenza infection,
sensitive and specific measures of vaccine receipt, and the use of a case test-negative design to control for
differences in healthcare-seeking behavior between vaccinated and unvaccinated patients. We propose to use
these methods to estimate influenza VE in preventing influenza-associated ambulatory care visits in two health
systems in Michigan, where we have been conducting annual assessments of VE since 2008. We will conduct
surveillance at adult and pediatric outpatient clinics, and we will enroll patients seeking care for acute
respiratory infections meeting a standard case definition. Vaccination status will be reported and documented,
and considered with laboratory-confirmed influenza outcomes to estimate VE in preventing influenza-
associated health care visits. Analyses will use the case test-negative design; those testing positive for
influenza will be cases, those testing negative will be controls. Modifiers and confounders of VE such as age,
health status, high-risk health conditions, education, time from illness onset to specimen collection, and
calendar time will be assessed. We will also estimate the population-based incidence of medically-attended
influenza and will identify infections due to respiratory syncytial virus (RSV) and other respiratory viruses in
later years of the study. We will pilot methods to monitor the development of influenza virus resistance to
antiviral medications which could inform similar studies carried out in a potential future influenza pandemic. In
addition to our proposed influenza surveillance and VE assessment in the outpatient setting, we propose to
continue our analyses of influenza VE and development of influenza antibodies among a prospectively
followed cohort of households with children which has been in place since 2010. This cohort will be used to
carry out complementary analyses of VE in preventing influenza illnesses of any severity which will be
identified through ongoing active surveillance. Households in this cohort are followed for multiple years,
enabling precise evaluations of repeated vaccination. Our current enrollment strategies will be augmented with
targeted enrollment of households with children under age 3. Blood specimens will be collected from adults
and children twice yearly; a third blood specimen will be...

## Key facts

- **NIH application ID:** 9948534
- **Project number:** 5U01IP001034-05
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** ARNOLD S MONTO
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $2,999,990
- **Award type:** 5
- **Project period:** 2016-08-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9948534

## Citation

> US National Institutes of Health, RePORTER application 9948534, US Influenza Vaccine Effectiveness Network (5U01IP001034-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9948534. Licensed CC0.

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