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| ID | Type | Description | Link |
|---|---|---|---|
| 507 | Other Identifier | Tehran University of Medical Sciences |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| four doses of Euvax B vaccine | Biological | 40 μg (2 ml) four doses of Euvax B vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2014 | |
| Reset | Nov 20, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2014 | Nov 20, 2014 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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) |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |