Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients (Transfluvac)
29. december 2011 opdateret af: Institut National de la Santé Et de la Recherche Médicale, France
Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
120 renal transplant recipients under triple immunosuppression will be immunized against influenza H1N1v.
The primary endpoint will be the humoral immunity assessed 21 days after each injection on day 0 and day 21:
- seroprotection rate, defined as the percentage of patients with an antibody title against Hemaglutinin ≥ 1/40e after immunization
- seroconversion rate, defined as the the percentage of patients with an antibody title against Hemaglutinin < 1/10e before immunization and ≥ 1/40e after or with a prevaccine title ≥1/10e increasing at least 4 fold after immunization
- seroconversion factor, defined as the ratio between pre and post vaccine geometrical means of the antibody titles.
Secondary endpoints will be:
- Seroconversion rate, seroprotection rate and seroconversion factor on day 182
- Percentage of patients with an antibody title > 1/40e on day 182 (Immune memory)
- Number and severity of clinical and biological adverse events
- Number of cases of pandemic H1N1v influenza virologically confirmed
- Study of associated parameters influencing the results of H1N1v vaccination in terms of seroprotection, seroconversion and seroconversion factor
- Assessment of the cellular immune response against H1N1v
- Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Lyon cedex 3, Frankrig, 69437
- Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique
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Paris, Frankrig, 75013
- Service d'urologie, GH Pitié Salpêtrière
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Lyon
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Pierre-Bénite cedex, Lyon, Frankrig, 69495
- Centre hospitalier Lyon Sud, service de néphrologie transplantation
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- Age > 18 and < 60 years old
- Signed information consent
- Social security coverage
- Renal transplantation > 6 months with a creatinine clearance > 20 ml/mn
- Stable renal function defined as serum creatinine variation < 20 % for the last three months
- Receiving a triple immunosuppression regimen including steroids, Calcineurine inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil or mycophenolic acid)
- Regular follow-up
For child bearing aged female:
- Negative urinary HCG
- Contraception during the first three months of the study
Exclusion criteria:
- Poor renal function defined as creatinine clairance < 20 ml/mn
- Unstable renal function defined as serum creatinine variations > 20 % during the last 3 months
- Cellular or humoral acute rejection episode during the last 3 months before inclusion
- Known HIV, HBV or HCV infection
- Other vaccine administered during the last 3 weeks before inclusion or scheduled in the month after the second vaccine injection
- Known allergy to egg proteins or to one the vaccine compounds
- Severe adverse events after prior administration of any influenza vaccine
- Multiple sclerosis
- Past history of Guillain Barre syndrome
- Fever at inclusion
- H1N1 influenza episode with positive virological tests during the last 6 months
- Contact with people infected with H1N1 influenza during the week prior to inclusion
- Cancer requiring radiotherapy or chemotherapy during the last 6 months
- Blood transfusion during the last 3 months
- Pregnancy during the last 3 months
- No follow-up
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
Tidsramme: after each vaccination and at 6 months
|
after each vaccination and at 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Faktiske)
1. januar 2010
Studieafslutning (Faktiske)
1. maj 2010
Datoer for studieregistrering
Først indsendt
16. november 2009
Først indsendt, der opfyldte QC-kriterier
12. marts 2010
Først opslået (Skøn)
15. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. december 2011
Sidst verificeret
1. juli 2010
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- C09-32
- 2009-016659-23 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .