Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00760175
First received: September 25, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. It has been thought that the response to the vaccine may be improved if it is given into the skin (intradermal) rather than the muscle (intramuscular). We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.


Condition Intervention
Influenza Virus
Influenza Vaccine
Biological: Vaxigrip (Aventis-Pasteur Canada)

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 Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients

Resource links provided by NLM:


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 Seroprotection rate: HIA titers of >/= 1:40 [ 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: 90
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intradermal versos intramuscular Biological: Vaxigrip (Aventis-Pasteur Canada)
The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.
Other Name: Influenza vaccine

Detailed Description:

The annual influenza vaccine is suggested for immunocompromised patients. However, the immunogenic response to this vaccine is suboptimal and ranges from 15-70%. In lung transplant recipients, responses to the influenza vaccine are poorest of all organ transplant groups. For example, a study with 43 stable lung transplant recipients showed that protective antibody developed in 19%, 30%, and 40% for the three antigens in the vaccine (only 8.6% of subjects developed protective antibody levels against all three). Similarly, 43% responded after a single dose of vaccine was given to 68 lung transplant recipients; response was significantly lower in those on mycophenolate mofetil (MMF). We have recently published a study in 60 lung transplant recipients where the standard influenza vaccine was immunogenic to at least one vaccine antigen in approximately 60% of the patients.

The study we propose is a prospective randomized control trial designed to assess the immunogenicity of the influenza vaccine given intradermally compared to the standard intramuscular vaccine in lung transplant recipients. Lung transplant recipients are unique in that their vaccine responses are the lowest of all organ groups and they stand to benefit most from an alternate vaccine strategy.

CLINICAL SIGNIFICANCE OF THE STUDY Lung transplant recipients appear to have one of the poorest humoral responses to influenza vaccination of all the organ transplant groups. However, influenza remains an important cause of morbidity in this population in whom protection is imperative. The current vaccine is suboptimal and newer strategies need to be studied to increase response rates. This subject area is of critical importance to study and especially in light of the threat of pandemic influenza.

OBJECTIVE AND HYPOTHESIS

  • To test the specific humoral and cellular response after the intradermal influenza vaccine.
  • To test the safety of the intradermal influenza vaccine in the lung transplant population.
  • We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Greater than 3 months post-transplant
  • Outpatient status

Exclusion Criteria:

  • Has already received influenza vaccination for 2008-2009 season
  • Egg allergy
  • Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
  • On anticoagulants such as warfarin that precludes intramuscular injection
  • 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: NCT00760175

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

Additional Information:
Publications:
Responsible Party: Dr. Deepali Kumar, University of Alberta - Division of Infection Diseases
ClinicalTrials.gov Identifier: NCT00760175     History of Changes
Other Study ID Numbers: 7407
Study First Received: September 25, 2008
Last Updated: February 16, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Lung transplant Recipients
Vaxigrip

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 April 22, 2014