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

NCT ID: NCT00445185

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Keywords

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Dialysis Pre-dialysis Hepatitis B vaccine vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Henogen Hepatitis B vaccine for uremic patients

Group Type EXPERIMENTAL

Henogen HB vaccine

Intervention Type BIOLOGICAL

Month 12, 24 and 36

2

Fendrix hepatitis B vaccine for uremic patients

Group Type ACTIVE_COMPARATOR

Fendrix vaccine

Intervention Type BIOLOGICAL

Month 12, 24 and 36

Interventions

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Henogen HB vaccine

Month 12, 24 and 36

Intervention Type BIOLOGICAL

Fendrix vaccine

Month 12, 24 and 36

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Henogen

Principal Investigators

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Joëlle Nortier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ULB Hôpital Erasme Département de Néphrologie

Locations

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O.L.Vrouwziekenhuis Aalst

Aalst, , Belgium

Site Status

RHMS La Madeleine ATH

Ath, , Belgium

Site Status

RHMS Clinique Louis Caty Baudour

Baudour, , Belgium

Site Status

CHU Brugmann (site V Horta) Service de néphrologie

Brussels, , Belgium

Site Status

ULB Hôpital Erasme Département de Néphrologie

Brussels, , Belgium

Site Status

AZ -VUB Dienst Nefrologie

Brussels, , Belgium

Site Status

Cliniques universitaires Saint Luc

Brussels, , Belgium

Site Status

CHU Hôpital civil de

Charleroi, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

CHU Tivoli

La Louvière, , Belgium

Site Status

UZ Gasthuisberg Leuven Nierziekten

Leuven, , Belgium

Site Status

CHU Andre VESALE

Montigny-le-Tilleul, , Belgium

Site Status

RHMS TournayService de néphrologie

Tournai, , Belgium

Site Status

Hospital JihlavaVrchlického

Jihlava, , Czechia

Site Status

Regional Hospital Liberec

Liberec, , Czechia

Site Status

University Hospital with Outpatient Clinic Ostrava

Ostrava, , Czechia

Site Status

Dept. of Internal Medicine StrahovSermirska 5

Prague, , Czechia

Site Status

Masaryk´s Hospital Socialni pece 3316/12A

Ústí nad Labem, , Czechia

Site Status

St. Rókus Hospital

Budapest, , Hungary

Site Status

St. István Hospital

Budapest, , Hungary

Site Status

Petz Aladár Teaching Hospital

Győr, , Hungary

Site Status

Pest County Flór Ferenc Hospital

Kistarcsa, , Hungary

Site Status

Vas and Szombathely County Markusovszky Hospital

Szombathely, , Hungary

Site Status

Countries

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Belgium Czechia Hungary

References

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Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Doman J, Barthelemy X, Crasta PD, Messier M, Houard S. Anti-HBs antibody persistence following primary vaccination with an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency. Hum Vaccin. 2011 Sep;7(9):913-8. doi: 10.4161/hv.7.9.16225. Epub 2011 Sep 1.

Reference Type DERIVED
PMID: 21892006 (View on PubMed)

Other Identifiers

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HN015/HBV-EXT001

Identifier Type: -

Identifier Source: org_study_id