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| Sponsor: | Henogen |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Henogen |
| ClinicalTrials.gov Identifier: | NCT00291980 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Biological: HB-AS02V vaccine Biological: HBVAXPRO vaccine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody. |
| Enrollment: | 185 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
HB-AS02V vaccine
|
Biological: HB-AS02V vaccine
HB-AS02V (20µg HBsAg) will be administered at Month 0
|
|
Active Comparator: 2
HBVAXPRO vaccine
|
Biological: HBVAXPRO vaccine
HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
|
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| O.L.Vrouwziekenhuis Aalst | |
| Aalst, Belgium, 9300 | |
| RHMS La Madeleine ATH | |
| ATH, Belgium, 7800 | |
| RHMS Clinique Louis Caty Baudour | |
| Baudour, Belgium, 7331 | |
| Cliniques universitaires Saint Luc | |
| Bruxelles, Belgium, 1200 | |
| ULB Hôpital Erasme Département de Néphrologie | |
| Bruxelles, Belgium | |
| CHU Brugmann (site V Horta) Service de néphrologie | |
| Bruxelles, Belgium, B-1020 | |
| CHU Hôpital civil de | |
| Charleroi, Belgium, 6000 | |
| UZ AntwerpenDienst nefrologie | |
| Edegem, Belgium, B-2650 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| CHU Tivoli | |
| La Louvière, Belgium, 7100 | |
| UZ Gasthuisberg Leuven Nierziekten | |
| Leuven, Belgium, 3000 | |
| CHU Andre VESALE | |
| Montigny le tilleul, Belgium, 6110 | |
| RHMS TournayService de néphrologie | |
| Tournai, Belgium, 7500 | |
| Czech Republic | |
| Clinic of Gerontology and MetabolismDepartment of NephrologyUniversity HospitalSokolska | |
| Hradec Kralove, Czech Republic, 581500 05 | |
| Hospital JihlavaVrchlického | |
| Jihlava, Czech Republic, 59586 33 | |
| Regional Hospital Liberec | |
| Liberec, Czech Republic, 46063 | |
| Dept. of NephrologyIII. Clinic of Internal DiseasesUniversity Hospital I.P.Pavlova | |
| Olomouc, Czech Republic, 6775 20 | |
| Infection Diseases and AIDS Treatment ClinicUniversity Hospital with Outpatient Clinic | |
| Ostrava - Poruba, Czech Republic, 1790708 52 | |
| Fresenius Medical Care - DS, s.r.o.: PardubiceDialysis Unit Kyjevska | |
| Pardubice, Czech Republic, 44532 03 | |
| Fresenius Medical Care - DS Prague 4 | |
| Prague, Czech Republic, 142 00 | |
| Dept. of Internal Medicine StrahovSermirska 5 | |
| Prague, Czech Republic, 169 00 | |
| Fresenius Medical Care - DS, s.r.o.: SokolovDialysis Unit Slovenska | |
| Sokolov, Czech Republic, 1863356 01 | |
| Hungary | |
| University of Debrecen Medical and Science CenterI. Medical Clinic for Internal Diseases Nephrology Department | |
| Debrecen, Hungary, .H-4012 | |
| Markhot Ferenc County HospitalFresenius Dialysis Center Baktai | |
| Eger, Hungary, H-3300 | |
| Vaszary Kolos HospitalFresenius Dialysis Center | |
| Esztergom, Hungary, H-2500 | |
| Petz Aladár Teaching Hospital Vasvári | |
| Győr, Hungary, H-9023 | |
| Hatvan Hospital Health Care ProviderFresenius Dialysis Center Hatvan . | |
| Hatvan, Hungary, H-3000 | |
| Vas and Szombathely County Markusovszky Hospital | |
| Szombathely, Hungary, 9700 | |
| Principal Investigator: | Christian Tielemans, MD, PhD | ULB Hôpital Erasme Département de Néphrologie |
More Information
| Responsible Party: | Sophie Houard CSO, Henogen |
| ClinicalTrials.gov Identifier: | NCT00291980 History of Changes |
| Obsolete Identifiers: | NCT00739804 |
| Other Study ID Numbers: | HN018/HBV-004 (105754) |
| Study First Received: | February 14, 2006 |
| Last Updated: | August 27, 2008 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
Dialysis Pre-dialysis Hepatitis B vaccine Prophylaxis hepatitis B infection |
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |