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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT201109147556N1 | Registry Identifier | Iranian Registry of Clinical Trials |
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The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
20 person of vaccinated individuals who have HBsAb<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle |
|
| Placebo | Placebo Comparator | will receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | one 40 mg Atorvastatin tablet orally per day for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum HBsAb level | HBsAb level in serum measurement with quantitative ELIZA method | 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| IL-4 level in WBC culture | IL-4 level measurement with polymerase chain reaction method | 1 month after vaccination |
| IL 17 level in WBC culture | IL 17 level measurement with polymerase chain reaction method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nematollah Jonaidi Jafari, MD | Baqiyatallah University of Medical Sciencesc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baqiyatallah University of Medical Sciences | Tehran | Tehran Province | Iran |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo |
| Drug |
one Placebo tablet orally per day for 10 days |
|
| 1 month after vaccination |
| TGF-beta level in WBC culture | TGF-beta level measurement with polymerase chain reaction method | 1 month after vaccination |
| IFN-gamma level in WBC culture | IFN-gamma level measurement with polymerase chain reaction method | 1 month after vaccination |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |