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

Purpose

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).

Condition	Intervention	Phase
Hepatitis B	Biological: Henogen HB vaccine Biological: Fendrix vaccine	Phase III

MedlinePlus related topics:

Hepatitis Hepatitis B

Drug Information available for:

Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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™

Further study details as provided by Henogen:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Months 12, 24 and 36. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of immune response [ Time Frame: Month 12, 24 and 36 ] [ Designated as safety issue: No ]
SAEs retrospective reporting [ Time Frame: Month 12, 24 and 36 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Henogen HB vaccine	Biological: Henogen HB vaccine Month 12, 24 and 36
2: Active Comparator Fendrix vaccine	Biological: Fendrix vaccine Month 12, 24 and 36

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445185

Locations


Belgium
	ULB Hôpital Erasme Département de Néphrologie
	Bruxelles, Belgium, 1070
	CHU Brugmann (site V Horta) Service de néphrologie
	Bruxelles, Belgium, 1020
	Cliniques universitaires Saint Luc
	Bruxelles, Belgium, 1200
	AZ -VUB Dienst Nefrologie
	Bruxelles, Belgium, 1090
	UZ Gasthuisberg Leuven Nierziekten
	Leuven, Belgium, 3000
	UZ Gent
	Gent, Belgium, 9000
	RHMS TournayService de néphrologie
	Tournai, Belgium, 7500
	CHU Andre VESALE
	Montigny le tilleul, Belgium, 6110
	CHU Tivoli
	La Louvière, Belgium, 7100
	O.L.Vrouwziekenhuis Aalst
	Aalst, Belgium, 9300
	RHMS Clinique Louis Caty Baudour
	Baudour, Belgium, 7331
	CHU Hôpital civil de
	Charleroi, Belgium, 6000
	RHMS La Madeleine ATH
	ATH, Belgium, 7800

Czech Republic
	Regional Hospital Liberec
	Liberec, Czech Republic, 46063
	Masaryk´s Hospital Socialni pece 3316/12A
	Usti nad Labem, Czech Republic, 401 13
	Dept. of Internal Medicine StrahovSermirska 5
	Prague, Czech Republic, 169 00
	University Hospital with Outpatient Clinic Ostrava
	Ostrava, Czech Republic, 708 52
	Hospital JihlavaVrchlického
	Jihlava, Czech Republic, 59586 33

Hungary
	St. István Hospital
	Budapest, Hungary, 1096
	St. Rókus Hospital
	Budapest, Hungary, 1085
	Petz Aladár Teaching Hospital
	Győr, Hungary, 9023
	Vas and Szombathely County Markusovszky Hospital
	Szombathely, Hungary, 9700
	Pest County Flór Ferenc Hospital
	Kistarcsa, Hungary, 2143

Sponsors and Collaborators

Henogen

Investigators


Principal Investigator:	Joëlle Nortier, MD, PhD	ULB Hôpital Erasme Département de Néphrologie

More Information

Responsible Party:	Henogen ( Sophie Houard CSO )
Study ID Numbers:	HN015/HBV-EXT001
First Received:	March 7, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00445185
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Henogen:

Dialysis

Pre-dialysis

Hepatitis B vaccine

vaccine

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Antibodies

Liver Diseases

Digestive System Diseases

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Henogen
Information provided by:	Henogen
ClinicalTrials.gov Identifier:	NCT00445185