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Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination

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ClinicalTrials.gov Identifier: NCT00291954
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : August 28, 2008
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Henogen

Tracking Information
First Submitted Date  ICMJE February 14, 2006
First Posted Date  ICMJE February 15, 2006
Last Update Posted Date August 28, 2008
Study Start Date  ICMJE March 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
Anti-HBs seroprotection rate [ Time Frame: Month 2 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2006)
Anti-HBs seroprotection rate at Month 2.
Change History Complete list of historical versions of study NCT00291954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
  • Anti-HBs Seroprotection rates for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  • Anti-HBs Seropositivity rates for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  • Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects [ Time Frame: Months 0, 1 and 2 ]
  • Anti-HBs Geometric Mean Concentrations calculated for all subjects. [ Time Frame: Months 0, 1 and 2 ]
  • Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall [ Time Frame: Month 0, 1 and 2 ]
  • Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall [ Time Frame: Month 0, 1 and 2 ]
  • Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 [ Time Frame: Month 0 to 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2006)
Anti-HBs antibody concentrations at Months 1, 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
Official Title  ICMJE A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination
Brief Summary Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
Detailed Description Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Biological: HB-AS02V
    HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
  • Biological: HBVAXPRO vaccine
    HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
Study Arms  ICMJE
  • Experimental: 1
    Henogen hepatitis B vaccine
    Intervention: Biological: HB-AS02V
  • Active Comparator: 2
    HBVAXPRO hepatitis B vaccine
    Intervention: Biological: HBVAXPRO vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2008)
257
Original Enrollment  ICMJE
 (submitted: February 14, 2006)
300
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • A male or female subject greater than or equal to 15 years of age at the time of study entry
  • Written informed consent obtained from the subject/ from the parent or guardian of the subject.
  • Seronegative for anti-HBc antibodies and for HBsAg at screening.
  • Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
  • Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
  • The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
  • Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.

Exclusion criteria

  • Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00291954
Other Study ID Numbers  ICMJE HN017/HBV-003 (105762)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sophie Houard CSO, Henogen
Study Sponsor  ICMJE Henogen
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Christian Tielemans, MD, PhD ULB Hôpital Erasme Département de Néphrologie
PRS Account Henogen
Verification Date August 2008

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