Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
- Conditions
- Hepatitis B
- Interventions
- Biological: HBVAXPRO vaccineBiological: HB-AS02V
- Registration Number
- NCT00291954
- Lead Sponsor
- Henogen
- Brief Summary
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
- Detailed Description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 HBVAXPRO vaccine HBVAXPRO hepatitis B vaccine 1 HB-AS02V Henogen hepatitis B vaccine
- Primary Outcome Measures
Name Time Method Anti-HBs seroprotection rate Month 2
- Secondary Outcome Measures
Name Time Method Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects Months 0, 1 and 2 Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall Month 0, 1 and 2 Anti-HBs Seroprotection rates for all subjects. Months 0, 1 and 2 Anti-HBs Geometric Mean Concentrations calculated for all subjects. Months 0, 1 and 2 Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall Month 0, 1 and 2 Anti-HBs Seropositivity rates for all subjects. Months 0, 1 and 2 Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 Month 0 to 2
Trial Locations
- Locations (25)
O.L.Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium
Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic
🇨🇿Ostrava - Poruba, Czech Republic
University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department
ðŸ‡ðŸ‡ºDebrecen, Hungary
Dept. of Heamodialysis Hospital JihlavaVrchlického
🇨🇿Jihlava, Czech Republic
Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska
🇨🇿Pardubice, Czech Republic
Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan .
ðŸ‡ðŸ‡ºHatvan, Hungary
Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska
🇨🇿Sokolov, Czech Republic
Markhot Ferenc County HospitalFresenius Dialysis Center Baktai
ðŸ‡ðŸ‡ºEger, Hungary
Zala County HospitalII. Medical Department Nephrology Zrinyi
ðŸ‡ðŸ‡ºZalaegerszeg, Hungary
RHMS TournayService de néphrologie
🇧🇪Tournai, Belgium
RHMS Clinique Louis Caty Baudour
🇧🇪Baudour, Belgium
RHMS La Madeleine ATH
🇧🇪ATH, Belgium
Cliniques universitaires Saint Luc
🇧🇪Bruxelles, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
🇧🇪Bruxelles, Belgium
ULB Hôpital Erasme Département de Néphrologie
🇧🇪Bruxelles, Belgium
CHU Hôpital civil de
🇧🇪Charleroi, Belgium
UZ Gent
🇧🇪Gent, Belgium
CHU Tivoli
🇧🇪La Louvière, Belgium
UZ AntwerpenDienst nefrologie
🇧🇪Edegem, Belgium
CHU Andre VESALE
🇧🇪Montigny le tilleul, Belgium
UZ Gasthuisberg Leuven Nierziekten
🇧🇪Leuven, Belgium
Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska
🇨🇿Hradec Kralove, Czech Republic
Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova
🇨🇿Olomouc, Czech Republic
Vaszary Kolos HospitalFresenius Dialysis Center
ðŸ‡ðŸ‡ºEsztergom, Hungary
Petz Aladár Teaching Hospital Vasvári
ðŸ‡ðŸ‡ºGyÅ‘r, Hungary