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Trial record 2 of 2 for:    Gentlemen

Protection From Influenza: Determining the Impact of Prior Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
NOAMA NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION
Information provided by (Responsible Party):
Janet McElhaney, Health Sciences North Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Influenza Biological: Flu Vaccine

Detailed Description:

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : December 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Case
older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)
Biological: Flu Vaccine
Control
matched control subjects (non-LCII)
Biological: Flu Vaccine



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII) and matched control subjects (non-LCII).
Criteria

Inclusion Criteria:

  1. Written informed consent provided by the participant.
  2. Age 65 years of age or older admitted to Health Sciences North with at least one the following:

    • Laboratory confirmed influenza illness
    • Acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
    • Any respiratory or influenza-like symptoms (dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness) that a test for influenza was negative.
  3. Willing to receive influenza vaccination in the subsequent flu season

Exclusion Criteria:

  1. Patients whose reason for hospital admission was unrelated to influenza or (for example patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory).
  2. Chest x-ray positive for pneumonia.
  3. Study participants who cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination.
  4. Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily).

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda Axler, BSc. 7055237300 ext 1924 aaxler@hsnri.ca

Locations
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Canada, Ontario
Health Sciences North Research Institute Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Amanda l Axler, BSc    705-523-7300 ext 1924    aaxler@amric.ca   
Contact: Beth Gentleman, BSc    705-523-7300 ext 2631    bgentleman@amric.ca   
Principal Investigator: Janet E McElhaney, MD         
Sponsors and Collaborators
Health Sciences North Research Institute
NOAMA NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION
Additional Information:

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Responsible Party: Janet McElhaney, Vice President of Research and Scientific Director, HSN Volunteer Association Chair in Healthy Aging, Medical Lead for Seniors Care and Consulting Geriatrician, Health Sciences North Research Institute
ClinicalTrials.gov Identifier: NCT03004040    
Other Study ID Numbers: Protection from Influenza
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases