Lung TransplantationPhase 4NCT00402805
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
A Phase 4 study testing Trivalent Inactivated Influenza Vaccine in people with Lung Transplantation and Influenza Vaccines, run by University Health Network, Toronto at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Transplantation, Influenza Vaccines
- What is being tested?
- Trivalent Inactivated Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lung transplant recipients greater than 3 months post-transplant
Who cannot join
- · 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Multi-Organ Transplant Program, University Health Network
Toronto, Ontario, M5G 2N2
About this study
The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients
Read the 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.
- Conditions
- Lung Transplantation, Influenza Vaccines
- Being tested
- Trivalent Inactivated Influenza Vaccine
- Keywords
- Influenza vaccine, Intradermal, Lung transplantation
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Inactivated Influenza VaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
HIA titers 4 weeks after influenza vaccination
Secondary outcomes (2)
Local and systemic adverse events to vaccination and rates
of allograft rejection in the 6 months following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionFeb 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Deepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402805
- Sponsor's protocol ID
- 06-0380-AE
- Status last verified
- Nov 2006
- First submitted
- 21 Nov 2006
- Last updated
- 16 Apr 2008
- Results posted
- No
Publications
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.
PubMed 10745238Mazzone 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.
PubMed 11829104Belshe 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.
PubMed 15525713Vilchez 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.
PubMed 12096793