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

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402805
• Other study ID #: 06-0380-AE
• 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:

• · 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

• Influenza Vaccines
• Influenza, Human
• Lung Transplantation

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