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

NCT ID: NCT00402805

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Lung Transplantation Influenza Vaccines

Keywords

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Influenza vaccine Intradermal Lung transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Trivalent Inactivated Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Lung transplant recipients greater than 3 months post-transplant

Exclusion Criteria

* ยท 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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Multi-Organ Transplant Program, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Soesman NM, Rimmelzwaan GF, Nieuwkoop NJ, Beyer WE, Tilanus HW, Kemmeren MH, Metselaar HJ, de Man RA, Osterhaus AD. Efficacy of influenza vaccination in adult liver transplant recipients. J Med Virol. 2000 May;61(1):85-93.

Reference Type BACKGROUND
PMID: 10745238 (View on PubMed)

Mazzone PJ, Mossad SB, Mawhorter SD, Mehta AC, Schilz RJ, Maurer JR. The humoral immune response to influenza vaccination in lung transplant patients. Eur Respir J. 2001 Dec;18(6):971-6. doi: 10.1183/09031936.01.00215201.

Reference Type BACKGROUND
PMID: 11829104 (View on PubMed)

Belshe RB, Newman FK, Cannon J, Duane C, Treanor J, Van Hoecke C, Howe BJ, Dubin G. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med. 2004 Nov 25;351(22):2286-94. doi: 10.1056/NEJMoa043555. Epub 2004 Nov 3.

Reference Type BACKGROUND
PMID: 15525713 (View on PubMed)

Vilchez RA, McCurry K, Dauber J, Lacono A, Griffith B, Fung J, Kusne S. Influenza virus infection in adult solid organ transplant recipients. Am J Transplant. 2002 Mar;2(3):287-91. doi: 10.1034/j.1600-6143.2002.20315.x.

Reference Type BACKGROUND
PMID: 12096793 (View on PubMed)

Other Identifiers

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06-0380-AE

Identifier Type: -

Identifier Source: org_study_id