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Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01180699
First received: June 10, 2010
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Influenza Vaccine
 Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Local and systemic adverse events to vaccination [ Time Frame: 24 hours, 48 hours and 7 days after each vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: influenza vaccine - intradermal
intradermal versus intramuscular
 Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza
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.
Active Comparator: influenza vaccine - intramuscular Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180699

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Deepali Kumar University of Alberta
  More Information

No publications provided

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01180699     History of Changes
Other Study ID Numbers: KUOA-02
Study First Received: June 10, 2010
Last Updated: April 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
adult solid organ transplant patients

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013