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Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

This study has been completed.
Sponsor:
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00445185
First received: March 7, 2007
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Hepatitis B
 Biological: Henogen HB vaccine
Biological: Fendrix vaccine
 Phase 3

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 Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henogen:

Primary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Months 12, 24 and 36. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of immune response [ Time Frame: Month 12, 24 and 36 ] [ Designated as safety issue: No ]
  • SAEs retrospective reporting [ Time Frame: Month 12, 24 and 36 ] [ Designated as safety issue: Yes ]
  • RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001). [ Time Frame: Month 12, 24 and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Henogen Hepatitis B vaccine for uremic patients
 Biological: Henogen HB vaccine
Month 12, 24 and 36
Active Comparator: 2
Fendrix hepatitis B vaccine for uremic patients
 Biological: Fendrix vaccine
Month 12, 24 and 36

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
  • Subjects who completed the full course of primary vaccination.

Exclusion Criteria:

  • Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445185

Locations
Belgium
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
RHMS La Madeleine ATH
Ath, Belgium, 7800
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium, 1070
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, 1020
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
AZ -VUB Dienst Nefrologie
Bruxelles, Belgium, 1090
CHU Hôpital civil de
Charleroi, Belgium, 6000
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
Hospital JihlavaVrchlického
Jihlava, Czech Republic, 59586 33
Regional Hospital Liberec
Liberec, Czech Republic, 46063
University Hospital with Outpatient Clinic Ostrava
Ostrava, Czech Republic, 708 52
Dept. of Internal Medicine StrahovSermirska 5
Prague, Czech Republic, 169 00
Masaryk´s Hospital Socialni pece 3316/12A
Usti Nad Labem, Czech Republic, 401 13
Hungary
St. István Hospital
Budapest, Hungary, 1096
St. Rókus Hospital
Budapest, Hungary, 1085
Petz Aladár Teaching Hospital
Győr, Hungary, 9023
Pest County Flór Ferenc Hospital
Kistarcsa, Hungary, 2143
Vas and Szombathely County Markusovszky Hospital
Szombathely, Hungary, 9700
Sponsors and Collaborators
Henogen
Investigators
Principal Investigator: Joëlle Nortier, MD, PhD ULB Hôpital Erasme Département de Néphrologie
  More Information

No publications provided by Henogen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sophie Houard CSO, Henogen
ClinicalTrials.gov Identifier: NCT00445185     History of Changes
Other Study ID Numbers: HN015/HBV-EXT001
Study First Received: March 7, 2007
Last Updated: November 18, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Henogen:
Dialysis
Pre-dialysis
Hepatitis B vaccine
vaccine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 18, 2013