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

Phase 4

• Conditions: Hepatitis B; Vaccination Failure
• Interventions: Drug: placebo; Drug: Atorvastatin

• Registration Number: NCT01548326
• Lead Sponsor: Nematollah Jonaidi Jafari

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-27
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-06
• Last Update Submitted: 2012-03-06
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	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
Atorvastatin	Atorvastatin	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum HBsAb level	1 month after vaccination	HBsAb level in serum measurement with quantitative ELIZA method

Secondary Outcome Measures

Name	Time	Method
IL-4 level in WBC culture	1 month after vaccination	IL-4 level measurement with polymerase chain reaction method
IL 17 level in WBC culture	1 month after vaccination	IL 17 level measurement with polymerase chain reaction method
TGF-beta level in WBC culture	1 month after vaccination	TGF-beta level measurement with polymerase chain reaction method
IFN-gamma level in WBC culture	1 month after vaccination	IFN-gamma level measurement with polymerase chain reaction method

Trial Locations

Locations (1)

Baqiyatallah University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of