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

Phase 4

Completed

• Conditions: Lung Transplantation; Influenza Vaccines

• Registration Number: NCT00402805
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2007-02
• Study Completion: 2007-07
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Lung transplant recipients greater than 3 months post-transplant

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HIA titers 4 weeks after influenza vaccination

Secondary Outcome Measures

Name	Time	Method
Local and systemic adverse events to vaccination and rates
of allograft rejection in the 6 months following vaccination

Trial Locations

Locations (1)

Multi-Organ Transplant Program, University Health Network; 🇨🇦 Toronto, Ontario, Canada