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

Renal Failure Clinical Trial

Official title:

A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468051
• Other study ID #: 507
• Secondary ID: 507
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: November 8, 2011
• Start date: October 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Biological:
• four doses of Euvax B vaccine
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis B surface antibody mIU/ml	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.	8-10 weeks after the 6-month dose of vaccine