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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT01086904
Collaborator
MCM Vaccines B.V. (Industry)
120
Enrollment
3
Locations
5.9
Duration (Months)
40
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: inactivated non adjuvanted pandemic H1N1 vaccine
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
May 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Specific humoral response 21 days after each administration Seroprotection and seroconversion rates [after each vaccination and at 6 months]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Lyon Sud, service de néphrologie transplantation Pierre-Bénite cedex Lyon France 69495
2 Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique Lyon cedex 3 France 69437
3 Service d'urologie, GH Pitié Salpêtrière Paris France 75013

Sponsors and Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • MCM Vaccines B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01086904
Other Study ID Numbers:
  • C09-32
  • 2009-016659-23
First Posted:
Mar 15, 2010
Last Update Posted:
Jan 2, 2012
Last Verified:
Jul 1, 2010
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
renal transplantation
immunosuppression
inflenza A (H1N1)
vaccine

Study Results

No Results Posted as of Jan 2, 2012