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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Henogen HB vaccine; Biological: Fendrix vaccine

• Registration Number: NCT00445185
• Lead Sponsor: Henogen

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2009-07
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Henogen HB vaccine	Henogen Hepatitis B vaccine for uremic patients
2	Fendrix vaccine	Fendrix hepatitis B vaccine for uremic patients

Primary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	Months 12, 24 and 36.

Secondary Outcome Measures

Name	Time	Method
Quality of immune response	Month 12, 24 and 36
SAEs retrospective reporting	Month 12, 24 and 36
RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).	Month 12, 24 and 36

Trial Locations

Locations (23)

St. István Hospital; 🇭🇺 Budapest, Hungary

CHU Brugmann (site V Horta) Service de néphrologie; 🇧🇪 Bruxelles, Belgium

AZ -VUB Dienst Nefrologie; 🇧🇪 Bruxelles, Belgium

O.L.Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

ULB Hôpital Erasme Département de Néphrologie; 🇧🇪 Bruxelles, Belgium

Cliniques universitaires Saint Luc; 🇧🇪 Bruxelles, Belgium

CHU Hôpital civil de; 🇧🇪 Charleroi, Belgium

Vas and Szombathely County Markusovszky Hospital; 🇭🇺 Szombathely, Hungary

RHMS Clinique Louis Caty Baudour; 🇧🇪 Baudour, Belgium

CHU Andre VESALE; 🇧🇪 Montigny Le Tilleul, Belgium

Hospital JihlavaVrchlického; 🇨🇿 Jihlava, Czech Republic

Dept. of Internal Medicine StrahovSermirska 5; 🇨🇿 Prague, Czech Republic

St. Rókus Hospital; 🇭🇺 Budapest, Hungary

UZ Gent; 🇧🇪 Gent, Belgium

UZ Gasthuisberg Leuven Nierziekten; 🇧🇪 Leuven, Belgium

Regional Hospital Liberec; 🇨🇿 Liberec, Czech Republic

RHMS La Madeleine ATH; 🇧🇪 Ath, Belgium

Petz Aladár Teaching Hospital; 🇭🇺 Győr, Hungary

Pest County Flór Ferenc Hospital; 🇭🇺 Kistarcsa, Hungary

CHU Tivoli; 🇧🇪 La Louvière, Belgium

RHMS TournayService de néphrologie; 🇧🇪 Tournai, Belgium

Masaryk´s Hospital Socialni pece 3316/12A; 🇨🇿 Usti Nad Labem, Czech Republic

University Hospital with Outpatient Clinic Ostrava; 🇨🇿 Ostrava, Czech Republic