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

NCT02268500 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2014-0656
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (3)

• Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens

  4 weeks

• Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens

  4 weeks

• Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens

  4 weeks

Secondary Outcomes (2)

• Number of Participants With Influenza Like Illness

  8 months

• Number of All-cause Hospitalizations

  8 months

Study Arms (2)

Standard dose influenza vaccine

ACTIVE COMPARATOR

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

Biological: Influenza vaccine

High dose influenza vaccine

ACTIVE COMPARATOR

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

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

Influenza vaccine

Also known as: Fluzone

High dose influenza vaccine; Standard dose influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Orly Vardeny, Associate Professor of Medicine
• Organization: University of Minnesota

ovardeny@umn.edu

612.467.4586

Study Officials

• Orly Vardeny, PharmD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 20, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-06

Locations

US (1)