An interventional study of four doses of Euvax B vaccine and 20 μg (1 ml) three doses of Euvax B vaccine in Renal Failure, sponsored by Tehran University of Medical Sciences. Completed. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-11-09.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Prevention
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.
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.
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's enrollment of 51 is above the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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 (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
Biological: 20 μg (1 ml) three doses of Euvax B vaccine
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)
20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
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.
Time frame: 8-10 weeks after the 6-month dose of vaccine
No study locations are listed for this record.
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences →