Influenza Clinical Trial
The investigators propose a unique methodology of studying infection and vaccination history and immune responses. As most studies in infection history are conducted on mice, limitations are inherent on their applicability to humans. A longitudinal comparison study following older adults (over the age of 65) hospitalized for influenza are followed through to their hospital discharge and vaccination in the following season. This will allow for the investigation of the course of infection, as well as impact on the response to vaccination.
Significance: This study will provide critical information on the best technique in vaccine
candidate testing and improve influenza treatment approaches. The long-term goal of this
research is to identify the T-cell responses that are surrogates (biomarkers) of serious
complications of influenza in older adults and predict vaccine efficacy (prevention of
influenza illness) and vaccine effectiveness (prevention of serious complications). Further,
translating new insights into age-related immune dysfunction to the design of new influenza
vaccines is critical to addressing this unmet need in the population aged 65 and older.
Innovation: The study will help in the validation of clinical tools and biomarkers as
prognostic indicators of influenza illness severity in vaccinated older adults, point-of-care
diagnostics that would direct other preventive strategies to reduce the impact of influenza
illness in vaccinated older adults, and correlates of protection to evaluate the potential of
new influenza vaccines to enhance protection against the serious complications of influenza
illness. The investigators have established that GrzB activity and the IFNg: IL-10 ratio in
influenza-stimulated PBMC correlate with protection against influenza, and preliminary data
to show that low GrzB activity in influenza-stimulated PBMC correlates with more severe
disease and higher levels of frailty. The innovations of this project are the established
methods for developing correlates of protection, the clinical insights into how frailty
affects immune-mediated protection against influenza, and the direct translation of this
research to provide a reasonable method for primary care clinicians to estimate vaccine
effectiveness in an individual older person. These results will translate to the practical
design of clinical trials to evaluate the potential for new influenza vaccines to better
protect against the serious complications of influenza and complement those based on antibody
titers and/or clinical outcomes alone.
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