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

Hepatitis B Clinical Trial

Official title:

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

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

• Hepatitis
• Hepatitis A
• Hepatitis B
• Vaccination Failure

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