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NCT Number: NCT00445185

Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or 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).

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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

16 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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Henogen HB vaccine

Biological

Month 12, 24 and 36

Fendrix vaccine

Biological

Month 12, 24 and 36

Primary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Months 12, 24 and 36.

Secondary outcomes

  1. Quality of immune response

    Time frame: Month 12, 24 and 36

  2. SAEs retrospective reporting

    Time frame: Month 12, 24 and 36

  3. 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

Sponsors and collaborators

Lead sponsor

Henogen

Industry

Registry information

Official study title

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™

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 8, 2007
Registry last updated
Nov 19, 2009

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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