Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

Conditions
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Hepatitis B, Vaccination Failure

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous 3 dose hepatitis B vaccination Negative HBc Ab Negative HBs Ag HBs Ab less than 10 in ELIZA Exclusion Criteria: positive serologic evidence of Hepatitis B infection Chronic use of Atorvastatin Immunosuppressive Disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>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 | Drug: Atorvastatin<br>* one 40 mg Atorvastatin tablet orally per day for 10 days<br>|
| Placebo Comparator: Placebo<br>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 | Drug: placebo<br>* one Placebo tablet orally per day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum HBsAb level | HBsAb level in serum measurement with quantitative ELIZA method | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis