- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01086904
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients (Transfluvac)
December 29, 2011 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lyon cedex 3, France, 69437
- Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique
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Paris, France, 75013
- Service d'urologie, GH Pitié Salpêtrière
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Lyon
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Pierre-Bénite cedex, Lyon, France, 69495
- Centre hospitalier Lyon Sud, service de néphrologie transplantation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
Time Frame: after each vaccination and at 6 months
|
after each vaccination and at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
November 16, 2009
First Submitted That Met QC Criteria
March 12, 2010
First Posted (Estimate)
March 15, 2010
Study Record Updates
Last Update Posted (Estimate)
January 2, 2012
Last Update Submitted That Met QC Criteria
December 29, 2011
Last Verified
July 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- C09-32
- 2009-016659-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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