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

Immunosuppression Clinical Trial

— Transfluvac  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086904
• Other study ID #: C09-32
• Secondary ID: 2009-016659-23
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2009
• Last updated: December 29, 2011
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immunosuppression
• Renal Transplant Recipients

Intervention

Biological:
• inactivated non adjuvanted pandemic H1N1 vaccine
two administrations at D and D21 (15 µg HA)

Locations

Country	Name	City	State
France	Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique	Lyon cedex 3
France	Service d'urologie, GH Pitié Salpêtrière	Paris
France	Centre hospitalier Lyon Sud, service de néphrologie transplantation	Pierre-Bénite cedex	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Sanofi Pasteur MSD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific humoral response 21 days after each administration Seroprotection and seroconversion rates		after each vaccination and at 6 months	No
Secondary	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	Yes