Renal Failure
Conditions
Keywords
predialysed, chronic, renal failure patients
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.
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.
Interventions
BIOLOGICALfour doses of Euvax B vaccine
40 μg (2 ml) four doses of Euvax B vaccine
BIOLOGICAL20 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)
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B surface antibody mIU/ml | 8-10 weeks after the 6-month dose of vaccine | 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. |
Outcome results
None listed