Protection From Influenza: Determining the Impact of Prior Infection
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|ClinicalTrials.gov Identifier: NCT03004040|
Recruitment Status : Unknown
Verified February 2018 by Janet McElhaney, Health Sciences North Research Institute.
Recruitment status was: Recruiting
First Posted : December 28, 2016
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment|
|Influenza||Biological: Flu Vaccine|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||1 Year|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)
Biological: Flu Vaccine
matched control subjects (non-LCII)
Biological: Flu Vaccine
- High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity. [ Time Frame: 2 years ]PBMCs from adults hospitalized for laboratory confirmed influenza illness (LCII) will be collected at admission and 30 days post hospitalization. These samples will be matched with hospitalized non-LCII adult controls. T-cells will be isolated from whole blood samples and gene expression of IFNg, IL10 and GrzB will be measured and compared between time points and subjects. These levels do not have a separate unit of measure.
- Vaccination in previously infected individuals increases the protection provided by subsequent vaccination and will be higher than those receiving vaccination alone (with no previous infection) [ Time Frame: 2 years ]Older adults hospitalized for influenza illness the previous season will be compared to matched, hospitalized older adults with influenza-like illness (non-LCII). PBMCs will be collected from each group, before receiving influenza vaccination and 4 weeks after vaccination. PBMCs will be challenged ex vivo with influenza virus and gene expression of CTL related genes will be measured and compared between each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004040
|Contact: Amanda Axler, BSc.||7055237300 ext email@example.com|
|Health Sciences North Research Institute||Recruiting|
|Sudbury, Ontario, Canada, P3E 5J1|
|Contact: Amanda l Axler, BSc 705-523-7300 ext 1924 firstname.lastname@example.org|
|Contact: Beth Gentleman, BSc 705-523-7300 ext 2631 email@example.com|
|Principal Investigator: Janet E McElhaney, MD|