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High Dose vs. Standard Influenza Vaccine in Adult SOT

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ClinicalTrials.gov Identifier: NCT03139565
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University Health Network, Toronto

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Immunosuppression Biological: Fluzone High-dose Influenza Vaccine Biological: Standard 2016-2017 Flu vaccine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing High-dose vs. Standard Influenza Vaccine in Adult Solid Organ Transplant Recipients
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Vaccine Safety (local and systemic adverse events to vaccination). [ Time Frame: 6 months ]
    Vaccine Safety assessed by local and systemic adverse events to vaccination.

  2. 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.

  3. 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. Vaccine Efficacy (influenza infection) [ Time Frame: 6 months ]
    Microbiology proven influenza infection in the 6 months following vaccination.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139565


Locations
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Canada, Ontario
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Deepali Kumar, Physician, Transplant Infectious Diseases, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03139565     History of Changes
Other Study ID Numbers: UHNTID004
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deepali Kumar, University Health Network, Toronto:
Influenza
Solid Organ Transplant
Infection
Vaccine
Immunogenicity
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs