NCT00445185

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2007

Typical duration for phase_3

Geographic Reach
3 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

2.3 years

First QC Date

March 7, 2007

Last Update Submit

November 18, 2009

Conditions

Hepatitis B

Keywords

DialysisPre-dialysisHepatitis B vaccinevaccine

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs antibody concentrations

    Months 12, 24 and 36.

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Henogen Hepatitis B vaccine for uremic patients

Biological: Henogen HB vaccine

2

ACTIVE COMPARATOR

Fendrix hepatitis B vaccine for uremic patients

Biological: Fendrix vaccine

Interventions

Henogen HB vaccineBIOLOGICAL

Month 12, 24 and 36

1
Fendrix vaccineBIOLOGICAL

Month 12, 24 and 36

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
  • Subjects who completed the full course of primary vaccination.

You may not qualify if:

  • Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

O.L.Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

RHMS La Madeleine ATH

Ath, 7800, Belgium

Location

RHMS Clinique Louis Caty Baudour

Baudour, 7331, Belgium

Location

CHU Brugmann (site V Horta) Service de néphrologie

Brussels, 1020, Belgium

Location

ULB Hôpital Erasme Département de Néphrologie

Brussels, 1070, Belgium

Location

AZ -VUB Dienst Nefrologie

Brussels, 1090, Belgium

Location

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

CHU Hôpital civil de

Charleroi, 6000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Gasthuisberg Leuven Nierziekten

Leuven, 3000, Belgium

Location

CHU Andre VESALE

Montigny-le-Tilleul, 6110, Belgium

Location

RHMS TournayService de néphrologie

Tournai, 7500, Belgium

Location

Hospital JihlavaVrchlického

Jihlava, 59586 33, Czechia

Location

Regional Hospital Liberec

Liberec, 46063, Czechia

Location

University Hospital with Outpatient Clinic Ostrava

Ostrava, 708 52, Czechia

Location

Dept. of Internal Medicine StrahovSermirska 5

Prague, 169 00, Czechia

Location

Masaryk´s Hospital Socialni pece 3316/12A

Ústí nad Labem, 401 13, Czechia

Location

St. Rókus Hospital

Budapest, 1085, Hungary

Location

St. István Hospital

Budapest, 1096, Hungary

Location

Petz Aladár Teaching Hospital

Győr, 9023, Hungary

Location

Pest County Flór Ferenc Hospital

Kistarcsa, 2143, Hungary

Location

Vas and Szombathely County Markusovszky Hospital

Szombathely, 9700, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 21892006DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Joëlle Nortier, MD, PhD

    ULB Hôpital Erasme Département de Néphrologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

CZ(5)BE(13)HU(5)