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

Sponsor

Nematollah Jonaidi Jafari (Other)

Overall Status

Unknown status

CT.gov ID

NCT01548326

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Vaccination Failure	Drug: Atorvastatin Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Atorvastatin one 40 mg Atorvastatin tablet orally per day for 10 days
Placebo Comparator: 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	Drug: placebo one Placebo tablet orally per day for 10 days

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Atorvastatin

one 40 mg Atorvastatin tablet orally per day for 10 days

Placebo Comparator: 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

Drug: placebo

one Placebo tablet orally per day for 10 days

Outcome Measures

Primary Outcome Measures

Change from baseline in serum HBsAb level [1 month after vaccination]
HBsAb level in serum measurement with quantitative ELIZA method

Secondary Outcome Measures

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