Clinical trial NCT02268500: VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
Official title: VAccination to Improve Clinical outComes in Heart Failure Trial (VACC-HeFT): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a randomized, double blind, active-control trial of high dose influenza vaccine compared to standard dose influenza vaccine for one season in adult participants with symptomatic heart failure(HF). The primary outcome measure is humoral (antibody-mediated) immune response, and secondary outcomes include cumulative incidence of influenza-like illness symptoms and all cause hospitalizations. The aim is to gather information on feasibility of this study design and effect size differences to inform a larger outcomes-based clinical trial.

The 5.8 million Individuals in the US with heart HF are at high risk for influenza infection and associated morbidity, mortality and increased health care costs despite annual influenza vaccination. Higher dose of vaccine is approved for use in older adults. Antibody-mediated immunity contributes to vaccine-induced protection from influenza illness. Investigators at University of Wisconsin(UW) Madison have demonstrated reduced antibody titers to influenza vaccination in patients with HF. Additionally, study team has shown in a pilot study that double dose influenza vaccine resulted in increased titers and was well tolerated.

A multi-center, prospective, randomized, open-label blinded-endpoint trial will be conducted with 20 participants assigned to the standard dose vaccine dose and 20 participants to high dose influenza vaccine. The primary outcome measure is the rate of seroconversion (4-fold rise in antibody titers to A/H3N2, A/H1N1, and B-type vaccine antigens), assessed 4 weeks post vaccination. The study will also examine feasibility differences in symptoms of influenza and all-cause hospitalizations between vaccine dose groups, and these data will be used for planning a subsequent outcomes-based clinical trial.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens
timeFrame: 4 weeks
measure: Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens
timeFrame: 4 weeks
measure: Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Participants With Influenza Like Illness
timeFrame: 8 months
measure: Number of All-cause Hospitalizations
timeFrame: 8 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Orly Vardeny, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References: