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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402805
Other study ID # 06-0380-AE
Secondary ID
Status Completed
Phase Phase 4
First received November 21, 2006
Last updated April 15, 2008
Start date October 2006
Est. completion date July 2007

Study information

Verified date November 2006
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Trivalent Inactivated Influenza Vaccine


Locations

Country Name City State
Canada Multi-Organ Transplant Program, University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Epub 2004 Nov 3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HIA titers 4 weeks after influenza vaccination
Secondary Local and systemic adverse events to vaccination and rates
Secondary of allograft rejection in the 6 months following vaccination
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