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

Hepatitis B Clinical Trial

Official 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™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445185
• Other study ID #: HN015/HBV-EXT001
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2007
• Last updated: November 18, 2009
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Henogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Biological:
• Henogen HB vaccine
Month 12, 24 and 36
• Fendrix vaccine
Month 12, 24 and 36

Locations

Country	Name	City	State
Belgium	O.L.Vrouwziekenhuis Aalst	Aalst
Belgium	RHMS La Madeleine ATH	Ath
Belgium	RHMS Clinique Louis Caty Baudour	Baudour
Belgium	AZ -VUB Dienst Nefrologie	Bruxelles
Belgium	CHU Brugmann (site V Horta) Service de néphrologie	Bruxelles
Belgium	Cliniques universitaires Saint Luc	Bruxelles
Belgium	ULB Hôpital Erasme Département de Néphrologie	Bruxelles
Belgium	CHU Hôpital civil de	Charleroi
Belgium	UZ Gent	Gent
Belgium	CHU Tivoli	La Louvière
Belgium	UZ Gasthuisberg Leuven Nierziekten	Leuven
Belgium	CHU Andre VESALE	Montigny Le Tilleul
Belgium	RHMS TournayService de néphrologie	Tournai
Czech Republic	Hospital JihlavaVrchlického	Jihlava
Czech Republic	Regional Hospital Liberec	Liberec
Czech Republic	University Hospital with Outpatient Clinic Ostrava	Ostrava
Czech Republic	Dept. of Internal Medicine StrahovSermirska 5	Prague
Czech Republic	Masaryk´s Hospital Socialni pece 3316/12A	Usti Nad Labem
Hungary	St. István Hospital	Budapest
Hungary	St. Rókus Hospital	Budapest
Hungary	Petz Aladár Teaching Hospital	Gyor
Hungary	Pest County Flór Ferenc Hospital	Kistarcsa
Hungary	Vas and Szombathely County Markusovszky Hospital	Szombathely

Sponsors (1)

Lead Sponsor	Collaborator
Henogen

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibody concentrations		Months 12, 24 and 36.	No
Secondary	Quality of immune response		Month 12, 24 and 36	No
Secondary	SAEs retrospective reporting		Month 12, 24 and 36	Yes
Secondary	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	No