NCT00125775

CompletedPhase 4

Does Extra-High Dose Hepatitis B Vaccination Confer Longer S...

Chinese University of Hong Kong Source

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Other study identifiers

Sponsor study identifier

CRE-2005.134

Study Type

interventional

Estimated enrollment

130

Locations

1 country

Sites

1

Timeline

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

Brief Summary

Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk population although the vaccine protection remains suboptimal and does not last long. The purpose of this study is to determine the best vaccination strategy over a 6-month period using recombinant hepatitis B vaccine (Engerix-B) in peritoneal dialysis patients. Current data show that the traditional Engerix-B vaccine dose (40 micrograms) does not always lead to protective and long-lasting hepatitis B surface antibody. The investigators, therefore, decided to compare the usual 40-micrograms with an 80-microgram dose strategy of vaccine protection.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 130 participants
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 1, 2005
Actual (reported)
First Posted
August 2, 2005
Actual (reported)
Primary Completion
December 2009
Actual (reported)
Study Completion
December 2009
Actual (reported)

Last Updated: January 7, 2010
Status Verified: July 2009
Last Update Submitted: January 6, 2010

Conditions

Peritoneal Dialysis Renal Disease, End-Stage

Outcome Measures

Primary Outcomes (1)

hepatitis B surface antibody anti-HBs level ≥ 10 IU/L 3 months after completion of the third dose and the persistence of protective anti-HBs 12 months after completion of the third dose of Engerix-B vaccine
18 months

Study Arms (2)

1

ACTIVE COMPARATOR

Engerix-B 40 mcg dose

Biological: Engerix-B

2

ACTIVE COMPARATOR

Engerix-B 80 mcg dose

Biological: Engerix-B

Interventions

Engerix-BBiological

Engerix-B at 0, 1, 6 months

12

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age above 18 years
End-stage renal disease and on maintenance peritoneal dialysis

Sponsors & Collaborators

Chinese University of Hong Kong
Otherlead

Study Sites (1)

Prince of Wales Hospital

New Territories, New Territories, SAR, Hong Kong

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Kai Ming Chow, MRCP
Prince of Wales Hospital, Shatin, Hong Kong
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

NCT00657657

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

Phase 4Completed

NCT03953950

Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients

Phase 4Unknown

NCT00240500

Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

Phase 4Completed

NCT02901951

Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B

Phase 4Completed

NCT02547103

Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection

Phase 4Unknown

NCT01138098

Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children

Phase 4Completed

Serologically negative for hepatitis B surface antigen (HBsAg) and antibody to hepatitis core antigen (anti-HBc)

No history of receiving hepatitis B vaccination

Willingness to give written informed consent and willingness to participate in and comply with the study protocol

You may not qualify if:

Expected survival less than 6 months
Those who refused vaccination
Active malignancy
Alcoholic liver disease
Chronic hepatitis C and/or human immunodeficiency virus (HIV) infection
Receiving immunosuppressive medications

Contact the study team to confirm eligibility.

Study Completion

December 2009

Actual (reported)

Last Updated

January 7, 2010

Record last verified: 2009-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00125775
Data provider: ClinicalTrials.gov
Source updated: 2010-01-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:15 UTC

Locations

HK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations