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- Klinische proef NCT00760175
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
A Randomized, Controlled Trial Comparing Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The annual influenza vaccine is suggested for immunocompromised patients. However, the immunogenic response to this vaccine is suboptimal and ranges from 15-70%. In lung transplant recipients, responses to the influenza vaccine are poorest of all organ transplant groups. For example, a study with 43 stable lung transplant recipients showed that protective antibody developed in 19%, 30%, and 40% for the three antigens in the vaccine (only 8.6% of subjects developed protective antibody levels against all three). Similarly, 43% responded after a single dose of vaccine was given to 68 lung transplant recipients; response was significantly lower in those on mycophenolate mofetil (MMF). We have recently published a study in 60 lung transplant recipients where the standard influenza vaccine was immunogenic to at least one vaccine antigen in approximately 60% of the patients.
The study we propose is a prospective randomized control trial designed to assess the immunogenicity of the influenza vaccine given intradermally compared to the standard intramuscular vaccine in lung transplant recipients. Lung transplant recipients are unique in that their vaccine responses are the lowest of all organ groups and they stand to benefit most from an alternate vaccine strategy.
CLINICAL SIGNIFICANCE OF THE STUDY Lung transplant recipients appear to have one of the poorest humoral responses to influenza vaccination of all the organ transplant groups. However, influenza remains an important cause of morbidity in this population in whom protection is imperative. The current vaccine is suboptimal and newer strategies need to be studied to increase response rates. This subject area is of critical importance to study and especially in light of the threat of pandemic influenza.
OBJECTIVE AND HYPOTHESIS
- To test the specific humoral and cellular response after the intradermal influenza vaccine.
- To test the safety of the intradermal influenza vaccine in the lung transplant population.
- We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alberta
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Edmonton, Alberta, Canada, T6G 2E1
- University of Alberta Hospital
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Lausanne, Zwitserland
- University Hospital of Lausanne
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age ≥ 18
- Greater than 3 months post-transplant
- Outpatient status
Exclusion Criteria:
- Has already received influenza vaccination for 2008-2009 season
- Egg allergy
- Previous life-threatening reaction to influenza vaccine (i.e. 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
- Unable to comply with study protocol
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: intradermal
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The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.
Andere namen:
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Actieve vergelijker: intramuscular
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The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40
Tijdsspanne: 4 weeks
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4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Lokale en systemische bijwerkingen van vaccinatie
Tijdsspanne: 24 uur, 48 uur en 7 dagen na elke vaccinatie
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24 uur, 48 uur en 7 dagen na elke vaccinatie
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Deepali Kumar, Msc, FRCPC, University of Alberta
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 7407
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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