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

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Henogen HB vaccine

Fendrix vaccine

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Dialysis, Pre-dialysis, Hepatitis B vaccine, vaccine

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Henogen Hepatitis B vaccine for uremic patients

Fendrix hepatitis B vaccine for uremic patients

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Quality of immune response

SAEs retrospective reporting

RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).

Full Information

NCT ID

NCT00445185

First Posted

March 7, 2007

Last Updated

November 18, 2009

Sponsor

Henogen

1. Study Identification

Unique Protocol Identification Number

NCT00445185

Brief Title

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

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™

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Henogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Dialysis, Pre-dialysis, Hepatitis B vaccine, vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Henogen Hepatitis B vaccine for uremic patients

Arm Title

Arm Type

Active Comparator

Arm Description

Fendrix hepatitis B vaccine for uremic patients

Intervention Type

Biological

Intervention Name(s)

Henogen HB vaccine

Intervention Description

Month 12, 24 and 36

Intervention Type

Biological

Intervention Name(s)

Fendrix vaccine

Intervention Description

Month 12, 24 and 36

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Months 12, 24 and 36.

Secondary Outcome Measure Information:

Title

Quality of immune response

Time Frame

Month 12, 24 and 36

Title

SAEs retrospective reporting

Time Frame

Month 12, 24 and 36

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joëlle Nortier, MD, PhD

Organizational Affiliation

ULB Hôpital Erasme Département de Néphrologie

Official's Role

Principal Investigator

Facility Information:

Facility Name

O.L.Vrouwziekenhuis Aalst

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

RHMS La Madeleine ATH

City

Ath

ZIP/Postal Code

7800

Country

Belgium

Facility Name

RHMS Clinique Louis Caty Baudour

City

Baudour

ZIP/Postal Code

7331

Country

Belgium

Facility Name

CHU Brugmann (site V Horta) Service de néphrologie

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

ULB Hôpital Erasme Département de Néphrologie

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

AZ -VUB Dienst Nefrologie

City

Bruxelles

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Cliniques universitaires Saint Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

CHU Hôpital civil de

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

CHU Tivoli

City

La Louvière

ZIP/Postal Code

7100

Country

Belgium

Facility Name

UZ Gasthuisberg Leuven Nierziekten

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU Andre VESALE

City

Montigny Le Tilleul

ZIP/Postal Code

6110

Country

Belgium

Facility Name

RHMS TournayService de néphrologie

City

Tournai

ZIP/Postal Code

7500

Country

Belgium

Facility Name

Hospital JihlavaVrchlického

City

Jihlava

ZIP/Postal Code

59586 33

Country

Czech Republic

Facility Name

Regional Hospital Liberec

City

Liberec

ZIP/Postal Code

46063

Country

Czech Republic

Facility Name

University Hospital with Outpatient Clinic Ostrava

City

Ostrava

ZIP/Postal Code

708 52

Country

Czech Republic

Facility Name

Dept. of Internal Medicine StrahovSermirska 5

City

Prague

ZIP/Postal Code

169 00

Country

Czech Republic

Facility Name

Masaryk´s Hospital Socialni pece 3316/12A

City

Usti Nad Labem

ZIP/Postal Code

401 13

Country

Czech Republic

Facility Name

St. Rókus Hospital

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

St. István Hospital

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

Petz Aladár Teaching Hospital

City

Győr

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Pest County Flór Ferenc Hospital

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Vas and Szombathely County Markusovszky Hospital

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

12. IPD Sharing Statement

Citations:

PubMed Identifier

21892006

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Hepatitis B

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial