Phase 4
N=48
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
Chronic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02268500 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens — 11; 12 Participants — p=0.89
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Influenza vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens |
11; 12 | 0.89 |
| PRIMARY Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens |
15; 17 | 0.43 |
| PRIMARY Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens |
7; 14 | 0.03 sig |
| SECONDARY Number of Participants With Influenza Like Illness |
8; 7 | 0.76 |
| SECONDARY Number of All-cause Hospitalizations |
15; 6 | 0.01 sig |
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.
Eligibility Criteria
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
- Participation in a clinical trial within 30 days
- Absence for more than 7 consecutive days during the surveillance period
Data sourced from ClinicalTrials.gov (NCT02268500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.