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

NCT ID: NCT02268500

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard dose influenza vaccine

Standard dose (45ug) influenza vaccine will be administered intramuscularly

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine

High dose influenza vaccine

High dose (180ug) influenza vaccine will be administered intramuscularly

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine

Interventions

Influenza vaccine

Influenza vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orly Vardeny, PharmD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2014-0656

Identifier Type: -

Identifier Source: org_study_id