# Mandatory_Estimates of Vaccine Effectiveness Against Medically-Attended, PCR-Confirmed Influenza in West South Central U.S.

> **NIH ALLCDC U01** · SCOTT AND WHITE MEMORIAL HOSPITAL · 2020 · $1,800,000

## Abstract

Influenza viruses are constantly evolving, resulting in vaccine strains being selected for reformulation every
season. Annual estimates of influenza vaccine effectiveness (VE) in preventing influenza-related morbidity are
essential in evaluating the protection provided by annual, nationwide vaccination programs. Our long-term goal
is to advance the understanding of the epidemiology of viral respiratory infections while measuring the public
health impact of immunization on reducing the overall burden of illness and on improving the health of the
population. We plan to systematically evaluate the influenza VE with the CDC ACIP recommended annual
universal immunization strategy in the Baylor Scott & White Health, Central Texas (BSWCTX) patient
population. The objective is to obtain reliable vaccination information for the enrolled population and provide
accurate estimates of annual VE to prevent influenza-associated medically-attended acute respiratory illness
(MAARI) in the vaccine age-eligible population. Our central hypothesis is that timely and efficient
measurement of annual VE and burden of illness due to seasonal/pandemic influenza, RSV and other
respiratory viruses is sustainable. The rationale is that by assessing the mid-season VE, ACIP can recommend
antiviral chemoprophylaxis and treatment for high risk groups, as needed. To accomplish the overall objective,
the following specific aims will be pursued: 1) Assess influenza VE against laboratory-confirmed influenza
among at least 1,000 children and adults, including at least 333 persons from each of three age groups (6
months – 17 years, 18-49 years and ≥50 years) with MAARI in ambulatory settings during each of 5 seasons
from 2016-17, with at least 100 among young children aged 6 months – 8 years and with at least 100 among
adults aged ≥65 years. 2) Evaluate disease burden due to seasonal influenza (during each of 5 seasons from
2016-17), RSV and other respiratory viruses (during seasons 3-5) among children (ages 6 months – 17 years),
adults (ages 18-64 years) and older adults (ages ≥65 years). 3) Develop influenza pandemic preparedness
operational plan and pilot research methods (during seasons 3-5) to describe the epidemiology of the novel
influenza virus infection, beginning whenever the next influenza pandemic is imminent anywhere in the world,
estimate MAARI incidence of pandemic influenza, estimate VE of seasonal and pandemic influenza vaccines
for prevention of pandemic influenza-associated MAARI, and evaluate the use and effectiveness of antiviral
agents for treatment of pandemic influenza. To accomplish these goals, we will estimate real-time VE for the
enrolled population in the ambulatory setting using a test-negative design, estimate burden of illness of
seasonal/pandemic influenza, RSV and other respiratory viruses in the BSWCTX source population, and
examine factors associated with VE. The proposed research is innovative in that it will generate new knowledge
in the methods u...

## Key facts

- **NIH application ID:** 9966817
- **Project number:** 5U01IP001039-05
- **Recipient organization:** SCOTT AND WHITE MEMORIAL HOSPITAL
- **Principal Investigator:** Manjusha Gaglani
- **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/9966817

## Citation

> US National Institutes of Health, RePORTER application 9966817, Mandatory_Estimates of Vaccine Effectiveness Against Medically-Attended, PCR-Confirmed Influenza in West South Central U.S. (5U01IP001039-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9966817. Licensed CC0.

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