VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)

Completed · Phase 4

Conditions studied: Chronic Heart Failure

In brief

A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20 patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed, as well as tolerability differences between groups.

Key facts

Study ID

NCT02268500

Run by

University of Wisconsin, Madison

People needed

48

Starts

2014-09-01

Expected to finish

2016-05-01

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults > 18 years old
• Able to give informed consent
• Systolic or diastolic dysfunction
• Previously or currently symptomatic heart failure
• Stable on current heart failure drug therapy regimen for > 30 days and no change in heart failure drug therapy regimen on day of enrollment
• Hospitalization (for any reason) in last 12 months
• Received influenza vaccination the prior season

You may not qualify if…

• History of allergic reaction or adverse event to influenza vaccine
• Documented severe allergy to egg products
• Unwilling or unable to give consent
• Moderate to severe acute febrile illness at baseline
• Immunologic conditions that may affect immune responses per clinical judgment of the investigators
• Use of immunosuppressants or immunomodulating therapies within 3 months of the study, including prednisone, cyclosporine, tacrolimus, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, and injectable interferons
• Participation in a clinical trial within 30 days
• Absence for more than 7 consecutive days during the surveillance period

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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