The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
two administrations at D and D21 (15 µg HA)
Centre hospitalier Lyon Sud, service de néphrologie transplantation
Pierre-Bénite, Lyon, France
Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique
Lyon, France
Service d'urologie, GH Pitié Salpêtrière
Paris, France
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
Time frame: after each vaccination and at 6 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.