Does Extra-High Dose Hepatitis B Vaccination Confer Longer Serological Protection in Peritoneal Dialysis Patients?

January 6, 2010 updated by: Chinese University of Hong Kong

Phase 4 Study of Recombinant Hepatitis B Vaccine in Peritoneal Dialysis Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the present randomized study is to evaluate the optimum strategy of recombinant hepatitis B vaccination in the maintenance of protective anti-HBs antibody among end-stage renal disease patients on peritoneal dialysis. This study is designed to establish whether a three-dose schedule of 80 microgram Engerix-B vaccine could maintain protective antibody response among dialysis patients. The secondary aim is to identify the effects of dosing on various subgroups of dialysis patients.

Viral hepatitis B infection remains a major health hazard for end-stage renal disease patients on dialysis. The direct costs of hepatitis B infection and long term impact on morbidity and renal transplantation are substantial. Apart from the devastating consequences of hepatitis B infection on patients on dialysis or after transplantation, infected patients are potential reservoirs for infecting other patients and haemodialysis staff. Antibody production achieved in renal patients is suboptimal; the most effective method of vaccination to prevent hepatitis B infections in end-stage renal disease subjects has hitherto been unanswered by the current literature and the latest Cochrane Collaboration review.

Given the relatively low seroconversion rate and maintenance of protective hepatitis antibody levels among end-stage renal disease patients, a treatment strategy using various doses of recombinant hepatitis B vaccine (Engerix-B) has been recently explored. In an observational study, the investigators demonstrated no statistically significant difference in response rate between patients receiving three recommended doses of Engerix-B intramuscularly (40 micrograms each dose) and those with four times the normal adult dose (80 micrograms each dose), (78% versus 100%, P = 0.23). On the other hand, according to the Kaplan-Meier estimates, 78 percent of patients in the 40 micrograms Engerix-B vaccination group and 96 percent of patients in the 80 micrograms dosing group had maintained the seroprotective levels of antibody to hepatitis B surface antigen (anti-HBs) at 12 months after initial response. This difference corresponds to an absolute risk reduction of 18 percent for losing the antibody response with a three-dose schedule of 80 micrograms Engerix-B vaccination program. In other words, the investigators estimate that giving Engerix-B 80 micrograms dose would lead to one extra end-stage renal disease subject with persistent seroprotective anti-HBs level at one year for every 5.6 patients treated (number needed to treat to benefit NNT, 5.6; 95% confidence interval, 5.4 to 5.8).

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • New Territories, Hong Kong, SAR
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Engerix-B 40 mcg dose
Biological: Engerix-B
Engerix-B at 0, 1, 6 months
ACTIVE_COMPARATOR: 2
Engerix-B 80 mcg dose
Biological: Engerix-B
Engerix-B at 0, 1, 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Kai Ming Chow, MRCP, Prince of Wales Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

August 1, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (ESTIMATE)

August 2, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005.134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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