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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zahra Khazaeipour, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01468051
First received: October 27, 2011
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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)
Other Name: 20 μg (1 ml) three doses of Euvax B vaccine

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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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

No publications provided

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
Study First Received: October 27, 2011
Last Updated: November 8, 2011
Health Authority: Iran: Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran, Farokhlagha Ahmadi , Morteza Ramezani , Effat Razeghi , Neda Ranjbarnovin , Zahra Khazaeipour.

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

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

ClinicalTrials.gov processed this record on May 19, 2013