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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00125775
First received: August 1, 2005
Last updated: January 6, 2010
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Peritoneal Dialysis
Renal Disease, End-Stage
Biological: Engerix-B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Recombinant Hepatitis B Vaccine in Peritoneal Dialysis Subjects

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125775

Locations
Hong Kong
Prince of Wales Hospital
New Territories, Hong Kong, SAR
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kai Ming Chow, MRCP Prince of Wales Hospital
  More Information

No publications provided

Responsible Party: Dr. Kai Ming CHOW, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00125775     History of Changes
Other Study ID Numbers: CRE-2005.134
Study First Received: August 1, 2005
Last Updated: January 6, 2010
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Kidney Diseases
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 20, 2014