Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.

NCT01808456 | Completed Phase 4 Results

• 1 other identifier: IFH20132015
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established. The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older. This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment. Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.

Conditions

Influenza, Human; Transplantation Infection

Keywords

kidney transplant; heart transplant; lung transplant; influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Local Site Reactions

  Evaluation of local and systemic reactions, use of analgesics or antipyretics.

  Day 1 and weeks 1, 4, and 12

• Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers

  Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40

  Week 1, 4, and 12

Secondary Outcomes (2)

• All Cause ED Visits/Unscheduled Clinic Visits

  day 1 - 3 months

• Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain

  Week 4 and Week 12

Study Arms (2)

High Dose Flu Vaccine

EXPERIMENTAL

influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration

Biological: influenza trivalent inactive vaccine high dose

Flu Vaccine

ACTIVE COMPARATOR

influenza trivalent inactive vaccine IM injection one time administration

Biological: influenza trivalent inactive vaccine

Interventions

influenza trivalent inactive vaccine BIOLOGICAL

one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients

Also known as: Fluzone(R), flu vaccine

Flu Vaccine

influenza trivalent inactive vaccine high dose BIOLOGICAL

one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients

Also known as: Fluzone High Dose (R)

High Dose Flu Vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• At least 30 days after organ transplantation of kidney, heart, or lung.
• In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
• Informed consent will be obtained from all the subjects before enrollment into the study, after the nature of the study has been fully explained to the satisfaction of the participant.
• Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
• Less than 30 days after transplantation procedure.
• Post operative complications of any type.
• Transplant organ dysfunction and/or under evaluation for possible infection.
• Recent acute transplant rejection and treatment for rejection for the past 30 days.
• Receiving another investigational drug or biologic for transplant.
• Previous history of allergic reaction to influenza vaccine, chicken egg or other unknown allergic reactions to flu vaccine or other vaccines.
• Acute ongoing respiratory illness.
• Bleeding diathesis or on anticoagulation therapy.
• Major surgery (pre-arranged) planned during the study period.
• Any condition that may preclude the participant from completion of study related activities; such as planned travel, or out of the state of residence and not able to return for follow-up visits or relocation of residence.
• Females of reproductive age unless proven to be urine HCG negative at the time of participation.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Ravinder Wali
• Organization: Inova Fairfax Hospital

ravinder.wali@inova.org

7037764001

Study Officials

• Ravinder Wali, MD

  Inova Fairfax Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 11, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 22, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-07

Locations

US (1)