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The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives & outcome measures of the extension phase at Months 12, 24 and 36. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Henogen Hepatitis B vaccine for uremic patients |
|
| 2 | Active Comparator | Fendrix hepatitis B vaccine for uremic patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henogen HB vaccine | Biological | Month 12, 24 and 36 |
| |
| Fendrix vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Months 12, 24 and 36. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of immune response | Month 12, 24 and 36 | |
| SAEs retrospective reporting | Month 12, 24 and 36 | |
| RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joëlle Nortier, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21892006 | Derived | Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Doman J, Barthelemy X, Crasta PD, Messier M, Houard S. Anti-HBs antibody persistence following primary vaccination with an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency. Hum Vaccin. 2011 Sep;7(9):913-8. doi: 10.4161/hv.7.9.16225. Epub 2011 Sep 1. |
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| Biological |
Month 12, 24 and 36 |
|
| Month 12, 24 and 36 |
| Ath |
| 7800 |
| Belgium |
| RHMS Clinique Louis Caty Baudour | Baudour | 7331 | Belgium |
| CHU Brugmann (site V Horta) Service de néphrologie | Brussels | 1020 | Belgium |
| ULB Hôpital Erasme Département de Néphrologie | Brussels | 1070 | Belgium |
| AZ -VUB Dienst Nefrologie | Brussels | 1090 | Belgium |
| Cliniques universitaires Saint Luc | Brussels | 1200 | Belgium |
| CHU Hôpital civil de | Charleroi | 6000 | 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 |
| Hospital JihlavaVrchlického | Jihlava | 59586 33 | Czechia |
| Regional Hospital Liberec | Liberec | 46063 | Czechia |
| University Hospital with Outpatient Clinic Ostrava | Ostrava | 708 52 | Czechia |
| Dept. of Internal Medicine StrahovSermirska 5 | Prague | 169 00 | Czechia |
| Masaryk´s Hospital Socialni pece 3316/12A | Ústí nad Labem | 401 13 | Czechia |
| St. Rókus Hospital | Budapest | 1085 | Hungary |
| St. István Hospital | Budapest | 1096 | Hungary |
| Petz Aladár Teaching Hospital | Győr | 9023 | Hungary |
| Pest County Flór Ferenc Hospital | Kistarcsa | 2143 | 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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