Recruiting

Influenza Protection

Sponsor:

Health Sciences North Research Institute

Code:

NCT03004040

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Flu Vaccine

Study Details

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.

Conditions

Influenza

Study ID

NCT03004040

Start date

Dec, 2016

Status verified date

Feb, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Case

older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)

Control

matched control subjects (non-LCII)

Interventions

Flu Vaccine

Primary outcome measure

  • High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Amanda Axler, BSc.

7055237300aaxler@hsnri.ca

Locations

Health Sciences North Research Institute

Recruiting

Sudbury, Ontario, Canada, P3E 5J1

Contacts

Principal Investigator:

Janet E McElhaney, MD

More Information

Sponsor

Health Sciences North Research Institute

Last update posted

Feb 23, 2018

Last verified

Feb, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Health Sciences North Research Institute on 2018-02-23.