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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445185
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : November 19, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Biological: Henogen HB vaccine Biological: Fendrix vaccine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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™
Study Start Date : March 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: Months 12, 24 and 36. ]

Secondary Outcome Measures :
  1. Quality of immune response [ Time Frame: Month 12, 24 and 36 ]
  2. SAEs retrospective reporting [ Time Frame: Month 12, 24 and 36 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445185

O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
RHMS La Madeleine ATH
Ath, Belgium, 7800
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
CHU Brugmann (site V Horta) Service de néphrologie
Bruxelles, Belgium, 1020
ULB Hôpital Erasme Département de Néphrologie
Bruxelles, Belgium, 1070
AZ -VUB Dienst Nefrologie
Bruxelles, Belgium, 1090
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
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
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
St. Rókus Hospital
Budapest, Hungary, 1085
St. István Hospital
Budapest, Hungary, 1096
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
Principal Investigator: Joëlle Nortier, MD, PhD ULB Hôpital Erasme Département de Néphrologie

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sophie Houard CSO, Henogen Identifier: NCT00445185     History of Changes
Other Study ID Numbers: HN015/HBV-EXT001
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Henogen:
Hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Immunologic Factors
Physiological Effects of Drugs