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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of these visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | HB-AS02V vaccine |
|
| 2 | Active Comparator | HBVAXPRO vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-AS02V vaccine | Biological | HB-AS02V (20µg HBsAg) will be administered at Month 0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody geometric mean concentrations. | Month 0 and Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rates for all subjects | Months 0, 1 | |
| Seropositivity rates for all subjects | Month 0 and at Month 1 | |
| Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Tielemans, MD, PhD | ULB Hôpital Erasme Département de Néphrologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O.L.Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| RHMS La Madeleine ATH |
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| HBVAXPRO vaccine |
| Biological |
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 |
|
| Month 0 and at Month 1 |
| Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects | Month 0 and Month 1 |
| Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms during the 4-day follow-up after vaccination | Month 0 |
| Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after vaccination | Month 0 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1 | Month 0 to 1 |
| Ath |
| 7800 |
| Belgium |
| RHMS Clinique Louis Caty Baudour | Baudour | 7331 | Belgium |
| Cliniques universitaires Saint Luc | Brussels | 1200 | Belgium |
| CHU Brugmann (site V Horta) Service de néphrologie | Brussels | B-1020 | Belgium |
| ULB Hôpital Erasme Département de Néphrologie | Brussels | Belgium |
| CHU Hôpital civil de | Charleroi | 6000 | Belgium |
| UZ AntwerpenDienst nefrologie | Edegem | B-2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| UZ Gasthuisberg Leuven Nierziekten | Leuven | 3000 | Belgium |
| CHU Andre VESALE | Montigny-le-Tilleul | 6110 | Belgium |
| RHMS TournayService de néphrologie | Tournai | 7500 | Belgium |
| Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska | Hradec Králové | 581500 05 | Czechia |
| Hospital JihlavaVrchlického | Jihlava | 59586 33 | Czechia |
| Regional Hospital Liberec | Liberec | 46063 | Czechia |
| Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova | Olomouc | 6775 20 | Czechia |
| Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | Ostrava - Poruba | 1790708 52 | Czechia |
| Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska | Pardubice | 44532 03 | Czechia |
| Fresenius Medical Care - DS Prague 4 | Prague | 142 00 | Czechia |
| Dept. of Internal Medicine StrahovSermirska 5 | Prague | 169 00 | Czechia |
| Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska | Sokolov | 1863356 01 | Czechia |
| University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department | Debrecen | .H-4012 | Hungary |
| Markhot Ferenc County HospitalFresenius Dialysis Center Baktai | Eger | H-3300 | Hungary |
| Vaszary Kolos HospitalFresenius Dialysis Center | Esztergom | H-2500 | Hungary |
| Petz Aladár Teaching Hospital Vasvári | Győr | H-9023 | Hungary |
| Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan . | Hatvan | H-3000 | Hungary |
| Vas and Szombathely County Markusovszky Hospital | Szombathely | 9700 | Hungary |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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