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

NCT00125775 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2010-01-07

No results posted yet for this study

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.

Conditions

  • Peritoneal Dialysis
  • Renal Disease, End-Stage

Interventions

BIOLOGICAL

Engerix-B

Engerix-B at 0, 1, 6 months

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Kai Ming Chow, MRCP · Prince of Wales Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125775 on ClinicalTrials.gov