NCT01086904

Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients

Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplant Recipients
• Immunosuppression

Interventions

Type	Name	Description
BIOLOGICAL	inactivated non adjuvanted pandemic H1N1 vaccine	two administrations at D and D21 (15 µg HA)

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-01-01
• Completion: 2010-05-01
• First posted: 2010-03-15
• Last updated: 2026-02-19

Locations

3 sites across 1 country: France