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

Tehran University of Medical Sciences

Status: Completed

Conditions: Renal Failure

Treatments: Biological: 20 μg (1 ml) three doses of Euvax B vaccine; Biological: four doses of Euvax B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01468051

507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

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

Experimental group

Description:

40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

Treatment:

Biological: four doses of Euvax B vaccine

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

Experimental group

Description:

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

Treatment:

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