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

NCT01468051 | Completed DMC

• 1 other identifier: 507
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Failure

Keywords

predialysed; chronic; renal failure patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

four doses of Euvax B vaccine BIOLOGICAL

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

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

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

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

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

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

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

MeSH Terms

Conditions

Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nephrology Research Center, Department of Nephrology and Dialysis, Imam Khomeini Hospital.

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 9, 2011

Record last verified: 2011-11