Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
Status and phase
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Treatments
Details and patient eligibility
About
The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients
Full description
Influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. Although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. After the initial i.m. injection, a second dose will be given intradermally 4 weeks later. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. We hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Lung transplant recipients greater than 3 months post-transplant
Exclusion criteria
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· Egg allergy
- Previous life-threatening reaction to influenza vaccine (ie 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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