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Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT01584908
Collaborator
(none)
68
Enrollment
1
Location
27
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    68 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients(AdVEnTR)
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      Adult kidney transplant recipients Greater than 3 months post-transplant

      Exclusion Criteria:

      Has already received influenza vaccination for 2012-2013 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

      Locations

      Site City State Country Postal Code
      1 University of Alberta Hospital Edmonton Alberta Canada

      Sponsors and Collaborators

      • University of Alberta

      Investigators

      • Principal Investigator: Deepali Kumar, MD, University Health Network, Toronto

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Alberta
      ClinicalTrials.gov Identifier:
      NCT01584908
      Other Study ID Numbers:
      • UofA - AdVEnTR
      First Posted:
      Apr 25, 2012
      Last Update Posted:
      Jan 1, 2015
      Last Verified:
      Dec 1, 2014
      Keywords provided by University of Alberta
      kidney transplant recipients
      Additional relevant MeSH terms:
      Influenza, Human

      Study Results

      No Results Posted as of Jan 1, 2015