A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00291941
First received: February 14, 2006
Last updated: August 27, 2008
Last verified: August 2008

February 14, 2006
August 27, 2008
February 2006
March 2007   (final data collection date for primary outcome measure)
Anti-HBs seroprotection rate at Month 2. [ Time Frame: Month 0 and 2 ] [ Designated as safety issue: No ]
Anti-HBs seroprotection rate at Month 2.
Complete list of historical versions of study NCT00291941 on ClinicalTrials.gov Archive Site
  • Anti-HBs antibody concentrations [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
  • Anti-HBs seroprotection rates for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
  • Anti-HBs seropositivity rates for all subjects [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
  • Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
  • Anti-HBs geometric mean concentrations calculated for all subjects. [ Time Frame: Months 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: No ]
  • Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. [ Time Frame: Months 0 and 7 ] [ Designated as safety issue: No ]
  • Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. [ Time Frame: Month 0 and 7 ] [ Designated as safety issue: No ]
  • Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. [ Time Frame: Month 0, 1, 2, 3, 6 and 7 ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. [ Time Frame: Month 0 to 7 ] [ Designated as safety issue: Yes ]
Anti-HBs antibody concentrations at Months 1, 2, 3, 6 and 7
Not Provided
Not Provided
 
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
  • Biological: Henogen HBV vaccine
    20µg, Month 0, 2 and 6
  • Biological: FENDRIX
    20 µg,Months 0, 1, 2 and 6
  • Experimental: 1
    Henogen HB vaccine
    Intervention: Biological: Henogen HBV vaccine
  • Active Comparator: 2
    Fendrix vaccine
    Intervention: Biological: FENDRIX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female subject 15 years of age or older at the time of the study entry.
  • Written informed consent obtained from the subject/ from the parent or guardian of the subject.
  • Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
  • Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
  • Non-childbearing potential female

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Use of any registered vaccine within 7 days before the first dose of study vaccine.
  • Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
  • History of hepatitis B infection.
  • Known exposure to hepatitis B virus within 6 months.
  • Use of immunoglobulins within six months preceding the first study vaccination.
  • Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
  • Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
  • Pregnant or lactating female
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Hungary
 
NCT00291941
HN014/HBV-001 (105757)
No
Sophie Houard CSO, Henogen
Henogen
GlaxoSmithKline
Principal Investigator: Christian Tielemans, MD, PhD ULB Hôpital Erasme Département de Néphrologie
Henogen
August 2008

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