High Dose vs. Standard Influenza Vaccine in Adult SOT

October 21, 2020 updated by: Deepali Kumar, University Health Network, Toronto

A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Influenza virus is an important cause of morbidity and mortality in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that standard vaccine has poor immunogenicity. Currently, there are no studies that define the effect of high-dose vaccine in adult transplant recipients even though this population could potentially benefit from it. The study will compare the immunogenicity of two different types of the influenza vaccine in 240 solid organ transplant patients during the 2016-2017 season. Patients will be randomized to receive either high-dose or standard dose influenza vaccine. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. The hypothesis is that the patients who receive the high-dose influenza vaccine will reach a significantly greater response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the high-dose influenza vaccine is successful, this strategy may lead to significant reduction in burden of disease, hospitalization, and long-term morbidity.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2N2
        • University Health Network, Toronto General Hospital, Multi-Organ Transplant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Organ transplant recipient on at least one immunosuppressive
  • Age >=18
  • Outpatient status
  • Greater than 3 months post transplant

Exclusion Criteria:

  • Has already received influenza vaccination for 2016-2017 season
  • Egg allergy or allergy to previous influenza vaccine
  • Febrile illness in the past one week
  • Active Cytomegalovirus viremia
  • Use of Rituximab in the past 6 months
  • Ongoing or recent (in past 30 days) therapy for acute rejection
  • Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
  • Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
  • Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluzone High-dose Influenza Vaccine
This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.
Biological: Fluzone High-dose Influenza Vaccine
This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.
Active Comparator: Standard 2016-2017 Flu vaccine
This will be the Standard 2016-2017 influenza vaccine made available by public health. It will contain 15 microgram of each strain and will be delivered in the deltoid muscle of non-dominant arm.
Biological: Standard 2016-2017 Flu vaccine
The intramuscular preparation of the vaccine used for the control group will be the Standard influenza vaccine made available by public health. The intramuscular dose (standard 0.5 mL) will contain 15 microgram antigen from each strain and delivered in the deltoid muscle by trained personnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine Immunogenicity (antibody titers)
Time Frame: 4 weeks

Comparing pre-vaccine and 4 weeks Post-Vaccine antibody titers. Positive vaccine response will be defined as:

  • Seroconversion rate of 4-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and
  • seroprotection rate determined by HAI tigers of 1>=40 post immunization
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine Safety (local and systemic adverse events to vaccination).
Time Frame: 6 months
Vaccine Safety assessed by local and systemic adverse events to vaccination.
6 months
Vaccine Safety (rates of rejection).
Time Frame: 6 months
Vaccine Safety assessed by rates of biopsy proven allograft rejection in the 6 months following vaccination.
6 months
Vaccine Immunogenicity (CMI)
Time Frame: 4 weeks
Analysis of cell-mediated immunity (CMI) in subgroup of 50 patients at 4 weeks post-vaccination vs pre-vaccination samples. CMI response will be correlated with HAI response.
4 weeks
Vaccine Efficacy (influenza infection)
Time Frame: 6 months
Microbiology proven influenza infection in the 6 months following vaccination.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHNTID004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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