Influenza Vaccine Clinical Trial
Official title:
A Randomized, Controlled Trial Comparing Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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