Back to resultsIntradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
Primary Purpose
Influenza Vaccine
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Influenza vaccine: Vaxigrip or Fluviral and Intanza
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Vaccine focused on measuring adult solid organ transplant patients
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 59,
- Greater than 3 months post-transplant,
- Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)
Exclusion Criteria:
- Has already received influenza vaccination for 2010-2011 season;
- Egg allergy,
- Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
- Ongoing therapy for rejection,
- Febrile illness in the past two weeks,
- Unable to provide informed consent,
- Unable to comply with study protocol
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
influenza vaccine - intradermal
influenza vaccine - intramuscular
Arm Description
intradermal versus intramuscular
Outcomes
Primary Outcome Measures
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen
Secondary Outcome Measures
Local and systemic adverse events to vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01180699
Brief Title
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
Official Title
A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
5. Study Description
Brief Summary
Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher 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 intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccine
Keywords
adult solid organ transplant patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
influenza vaccine - intradermal
Arm Type
Experimental
Arm Description
intradermal versus intramuscular
Arm Title
influenza vaccine - intramuscular
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine: Vaxigrip or Fluviral and Intanza
Intervention Description
Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.
Primary Outcome Measure Information:
Title
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Local and systemic adverse events to vaccination
Time Frame
24 hours, 48 hours and 7 days after each vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 59,
Greater than 3 months post-transplant,
Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)
Exclusion Criteria:
Has already received influenza vaccination for 2010-2011 season;
Egg allergy,
Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
Ongoing therapy for rejection,
Febrile illness in the past two weeks,
Unable to provide informed consent,
Unable to comply with study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Kumar
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
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