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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

March 7, 2007
November 18, 2009
March 2007
July 2009   (final data collection date for primary outcome measure)
Anti-HBs antibody concentrations [ Time Frame: Months 12, 24 and 36. ] [ Designated as safety issue: No ]
Anti-HBs antibody concentrations at Months 12, 24 and 36.
Complete list of historical versions of study NCT00445185 on ClinicalTrials.gov Archive Site
  • 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 ]
Quality of immune response at M12, 24 & 36, and SAEs (retrospective reporting).
Not Provided
Not Provided
 
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
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™

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
  • Biological: Henogen HB vaccine
    Month 12, 24 and 36
  • Biological: Fendrix vaccine
    Month 12, 24 and 36
  • Experimental: 1
    Henogen Hepatitis B vaccine for uremic patients
    Intervention: Biological: Henogen HB vaccine
  • Active Comparator: 2
    Fendrix hepatitis B vaccine for uremic patients
    Intervention: Biological: Fendrix vaccine
Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Domán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Hungary
 
NCT00445185
HN015/HBV-EXT001
No
Sophie Houard CSO, Henogen
Henogen
Not Provided
Principal Investigator: Joëlle Nortier, MD, PhD ULB Hôpital Erasme Département de Néphrologie
Henogen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP