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Completed

NCT Number: NCT03139565

High Dose vs. Standard Influenza Vaccine in Adult SOT

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.

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Key information

Conditions

Influenza Immunosuppression Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluzone High-dose Influenza Vaccine

Biological

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.

Standard 2016-2017 Flu vaccine

Biological

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
May 4, 2017
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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