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Clinical Trials/NCT00291954
NCT00291954CompletedPhase 3

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

Henogen49 sites in 3 countries257 target enrollmentStarted: March 1, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Henogen
Enrollment
257
Locations
49
Primary Endpoint
Anti-HBs seroprotection rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Anti-HBs seroprotection rate

Time Frame: Month 2

Secondary Outcomes

  • Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects(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(Month 0, 1 and 2)
  • Anti-HBs Seroprotection rates for all subjects.(Months 0, 1 and 2)
  • Anti-HBs Geometric Mean Concentrations calculated for all subjects.(Months 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(Month 0, 1 and 2)
  • Anti-HBs Seropositivity rates for all subjects.(Months 0, 1 and 2)
  • Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2(Month 0 to 2)

Investigators

Sponsor
Henogen
Sponsor Class
Industry

Study Sites (49)

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