Hepatitis B Clinical Trial
Official title:
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Verified date | March 2012 |
Source | Baqiyatallah Medical Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
Status | Enrolling by invitation |
Enrollment | 52 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Baqiyatallah University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Nematollah Jonaidi Jafari |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in serum HBsAb level | HBsAb level in serum measurement with quantitative ELIZA method | 1 month after vaccination | No |
Secondary | IL-4 level in WBC culture | IL-4 level measurement with polymerase chain reaction method | 1 month after vaccination | No |
Secondary | IL 17 level in WBC culture | IL 17 level measurement with polymerase chain reaction method | 1 month after vaccination | No |
Secondary | TGF-beta level in WBC culture | TGF-beta level measurement with polymerase chain reaction method | 1 month after vaccination | No |
Secondary | IFN-gamma level in WBC culture | IFN-gamma level measurement with polymerase chain reaction method | 1 month after vaccination | No |
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