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

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase

Completed

Phase 2

Conditions

Renal Transplant Recipients

Immunosuppression

Treatments

Biological: inactivated non adjuvanted pandemic H1N1 vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01086904

2009-016659-23 (EudraCT Number)

C09-32

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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