Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
Condition: Influenza Virus; Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Vaxigrip (Aventis-Pasteur Canada)
Intervention type(s): Biological
Intervention description(s): 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 intervention name(s): Influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Lung transplant Recipients; Vaxigrip