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Completed

NCT Number: NCT00291954

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

O.L.Vrouwziekenhuis Aalst, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HB-AS02V

Biological

HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1

HBVAXPRO vaccine

Biological

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

Primary outcomes

  1. Anti-HBs seroprotection rate

    Time frame: Month 2

Secondary outcomes

  1. Anti-HBs Seroprotection rates for all subjects.

    Time frame: Months 0, 1 and 2

  2. Anti-HBs Seropositivity rates for all subjects.

    Time frame: Months 0, 1 and 2

  3. 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

  4. Anti-HBs Geometric Mean Concentrations calculated for all subjects.

    Time frame: Months 0, 1 and 2

  5. 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

  6. 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

  7. Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2

    Time frame: Month 0 to 2

Sponsors and collaborators

Lead sponsor

Henogen

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 15, 2006
Registry last updated
Aug 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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