Clinical trial NCT00760175: Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
Official title: A Randomized, Controlled Trial Comparing Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Virus
Influenza Vaccine
Keywords: Lung transplant Recipients
Vaxigrip
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2008-09-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40
timeFrame: 4 weeks
Secondary outcomes:
measure: Local and systemic adverse events to vaccination
timeFrame: 24 hours, 48 hours and 7 days after each vaccination
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: University of Alberta
name: Deepali Kumar, Msc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manuel O, Humar A, Chen MH, Chernenko S, Singer LG, Cobos I, Kumar D. Immunogenicity and safety of an intradermal boosting strategy for vaccination against influenza in lung transplant recipients. Am J Transplant. 2007 Nov;7(11):2567-72. doi: 10.1111/j.1600-6143.2007.01982.x. Epub 2007 Oct 1.