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

NCT00125775 | Completed Phase 4

• 1 other identifier: CRE-2005.134
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

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-B BIOLOGICAL

Engerix-B at 0, 1, 6 months

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

New Territories, New Territories, SAR, Hong Kong

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai Ming Chow, MRCP

  Prince of Wales Hospital

  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 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-07

Locations

HK (1)