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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01548326
Other study ID # behdasht-90-6-16
Secondary ID IRCT201109147556
Status Enrolling by invitation
Phase Phase 4
First received February 27, 2012
Last updated March 6, 2012
Start date September 2011
Est. completion date July 2012

Study information

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

Clinical Trial Summary

The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.


Description:

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin
one 40 mg Atorvastatin tablet orally per day for 10 days
placebo
one Placebo tablet orally per day for 10 days

Locations

Country Name City State
Iran, Islamic Republic of Baqiyatallah University of Medical Sciences Tehran

Sponsors (1)

Lead Sponsor Collaborator
Nematollah Jonaidi Jafari

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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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