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Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468051
First Posted: November 9, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zahra Khazaeipour, Tehran University of Medical Sciences
  Purpose

Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination.

In this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.


Condition Intervention
Renal Failure Biological: four doses of Euvax B vaccine Biological: 20 μg (1 ml) three doses of Euvax B vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

Resource links provided by NLM:


Further study details as provided by Zahra Khazaeipour, Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Hepatitis B surface antibody mIU/ml [ Time Frame: 8-10 weeks after the 6-month dose of vaccine ]
    Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody.


Enrollment: 51
Study Start Date: October 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 μg (2 ml) four doses of Euvax B vaccine
40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Biological: four doses of Euvax B vaccine
40 μg (2 ml) four doses of Euvax B vaccine
Other Name: Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Experimental: 20 μg (1 ml) three doses of Euvax B vaccine
20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Biological: 20 μg (1 ml) three doses of Euvax B vaccine
20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

Detailed Description:
In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.
  Eligibility

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • predialysis patients,
  • > 18 years with mild and moderate chronic renal failure,
  • serum creatinine between 1.5-6 mg/dl

Exclusion Criteria:

  • patients with severe renal failure,
  • serum creatinine > 6 mg/dl,
  • requiring dialysis or expected to require dialysis within 1 year,
  • receiving immunosuppressive treatment,
  • known lymphoproliferative disorder.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Zahra Khazaeipour, Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital., Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01468051     History of Changes
Other Study ID Numbers: 507
507 ( Other Identifier: Tehran University of Medical Sciences )
First Submitted: October 27, 2011
First Posted: November 9, 2011
Last Update Posted: October 12, 2017
Last Verified: November 2011

Keywords provided by Zahra Khazaeipour, Tehran University of Medical Sciences:
predialysed
chronic
renal failure patients

Additional relevant MeSH terms:
Hepatitis B
Renal Insufficiency
Kidney Failure, Chronic
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Vaccines
Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents