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

NCT ID: NCT01468051

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

four doses of Euvax B vaccine

Intervention Type BIOLOGICAL

40 μg (2 ml) four doses of Euvax B vaccine

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)

Group Type EXPERIMENTAL

20 μg (1 ml) three doses of Euvax B vaccine

Intervention Type BIOLOGICAL

20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

Interventions

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four doses of Euvax B vaccine

40 μg (2 ml) four doses of Euvax B vaccine

Intervention Type 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)

Intervention Type BIOLOGICAL

Other Intervention Names

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Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Khazaeipour

Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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507

Identifier Type: OTHER

Identifier Source: secondary_id

507

Identifier Type: -

Identifier Source: org_study_id