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Completed

NCT Number: NCT00402805

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

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

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Key information

Conditions

Lung Transplantation Infections Influenza Vaccines Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Multi-Organ Transplant Program, University Health Network

Toronto, Ontario, M5G 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trivalent Inactivated Influenza Vaccine

Biological

Primary outcomes

  1. HIA titers 4 weeks after influenza vaccination

Secondary outcomes

  1. Local and systemic adverse events to vaccination and rates

  2. of allograft rejection in the 6 months following vaccination

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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