VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) (NCT02268500) | Clinical Trial Compass
CompletedPhase 4
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
United States48 participantsStarted 2014-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens
Timeframe: 4 weeks
2
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens
Timeframe: 4 weeks
3
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens