Prevention of hospitalization has long been viewed as a major health benefit of the use of influenza vaccine. This was, in large part, the rationale for the initial vaccination programs targeting the elderly and those with underlying health conditions. However, in the last decade, questions have been raised about the value of such programs. Modern study designs to assess vaccine effectiveness (VE) have required laboratory confirmation of influenza infection, as well as documentation of vaccine receipt and the use of a test-negative design to control for differences in healthcare-seeking behavior between vaccinated and unvaccinated patients. There is a need for current estimates of VE in preventing influenza-associated hospitalization using these methods. We propose estimation of influenza vaccine effectiveness in preventing influenza hospitalization in two health systems in Michigan, where we have been conducting annual assessments of VE in various populations since 2008. We will conduct surveillance at two hospitals, and will enroll adult in-patients with acute respiratory infection. Vaccination status will be reported and documented, and considered with laboratory-confirmed influenza outcomes to estimate vaccine effectiveness for prevention of hospitalization. Analyses will use a test- negative design; those testing positive for influenza ar cases, those testing negative are controls. Modifiers and confounders of vaccine effectiveness such as age, health status, high-risk health conditions, functional status, frailty, education, tim from illness onset to specimen collection, calendar time, and propensity for vaccination will be assessed. In addition to our proposed influenza surveillance and VE assessment, we propose an estimation of the incidence of hospitalization in adults due to respiratory syncytial virus (RSV and other respiratory viruses. This will allow for the evaluation of bias in influenza VE assessment due to interaction between influenza vaccination, infection, and non-influenza respiratory viruses, and will establish a platform for the future evaluation of RSV vaccines. We will accomplish these additional objectives by expanding our surveillance to months before and after the typical influenza season and evaluating specimens by molecular methods for RSV and other respiratory viruses.

Public Health Relevance

The proposed research is relevant to public health because of the need for current estimates of influenza vaccine effectiveness in preventing influenza-associated hospitalization using laboratory-confirmed outcomes and test-negative study design. We propose estimation of influenza vaccine effectiveness in preventing influenza hospitalization at two hospitals in Michigan, where we have been conducting annual assessments of VE in various populations since 2008, as well as an estimation of incidence of hospitalization in adults due to respiratory syncytial virus and other respiratory viruses. This research is relevant to the mission of the NIAID in that it will inform efforts to guide vaccination and control policies and improve initiatives to prevent severe infections with influenza, respiratory syncytial virus, and other infections.

Agency
National Institute of Health (NIH)
Institute
National Center for Immunication and Respiratory Diseases (NCIRD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01IP000974-02
Application #
9117306
Study Section
Special Emphasis Panel (ZIP1)
Program Officer
Yang, Amy
Project Start
2015-08-01
Project End
2020-07-31
Budget Start
2016-08-01
Budget End
2017-07-31
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Segaloff, H E; Petrie, J G; Malosh, R E et al. (2018) Severe morbidity among hospitalised adults with acute influenza and other respiratory infections: 2014-2015 and 2015-2016. Epidemiol Infect 146:1350-1358
Malosh, Ryan E; Martin, Emily T; Callear, Amy P et al. (2017) Respiratory syncytial virus hospitalization in middle-aged and older adults. J Clin Virol 96:37-43