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

Phase 2

Completed

• Conditions: Immunosuppression; Renal Transplant Recipients

• Registration Number: NCT01086904
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-16
• Primary Completion: 2010-01
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Study Completion: 2010-05
• Status Verified: 2010-07
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates	after each vaccination and at 6 months

Secondary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (3)

Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique; 🇫🇷 Lyon cedex 3, France

Centre hospitalier Lyon Sud, service de néphrologie transplantation; 🇫🇷 Pierre-Bénite cedex, Lyon, France

Service d'urologie, GH Pitié Salpêtrière; 🇫🇷 Paris, France