Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402805

Enrollment

Registered

2006-11-22

Start date

2006-10-31

Completion date

2007-07-31

Last updated

2008-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Vaccines, Lung Transplantation

Keywords

Influenza vaccine, Intradermal, Lung transplantation

Brief summary

The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients

Detailed 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.

Interventions

BIOLOGICALTrivalent Inactivated Influenza Vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Lung transplant recipients greater than 3 months post-transplant

Exclusion criteria

* · 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

Design outcomes

Primary

Measure	Time frame
HIA titers 4 weeks after influenza vaccination	—

Secondary

Measure	Time frame
Local and systemic adverse events to vaccination and rates	—
of allograft rejection in the 6 months following vaccination	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026