Protection From Influenza: Determining the Impact of Prior Infection

NCT03004040 | Unknown

• 1 other identifier: Protection from Influenza
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity.

  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.

  2 years

Secondary Outcomes (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)

  2 years

Study Arms (2)

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

Interventions

Flu Vaccine BIOLOGICAL

Case; Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• Written informed consent provided by the participant.
• 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.
• Willing to receive influenza vaccination in the subsequent flu season

You may not qualify if:

• 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).
• Chest x-ray positive for pneumonia.
• Study participants who cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination.
• Immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily).

Sponsors & Collaborators

• Health Sciences North Research Institute: lead
• NOAMA NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION: collaborator

Study Sites (1)

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Amanda Axler, BSc.

CONTACT

7055237300; aaxler@hsnri.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Research and Scientific Director, HSN Volunteer Association Chair in Healthy Aging, Medical Lead for Seniors Care and Consulting Geriatrician

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 28, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)