Clinical trial NCT01086904: Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
Official title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplant Recipients
Immunosuppression
Keywords: renal transplantation
immunosuppression
inflenza A (H1N1)
vaccine
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: MCM Vaccines B.V.
First posted: 2010-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
timeFrame: after each vaccination and at 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Pierre-Bénite cedex
country: France
facility: Centre hospitalier Lyon Sud, service de néphrologie transplantation
state: Lyon
city: Lyon cedex 3
country: France
facility: Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique
city: Paris
country: France
facility: Service d'urologie, GH Pitié Salpêtrière
Study officials:
References: