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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University

ClinicalTrials.gov Identifier:

NCT01548326

First received: February 27, 2012

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

March 6, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in serum HBsAb level [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

HBsAb level in serum measurement with quantitative ELIZA method

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01548326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IL-4 level in WBC culture [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
IL-4 level measurement with polymerase chain reaction method
IL 17 level in WBC culture [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
IL 17 level measurement with polymerase chain reaction method
TGF-beta level in WBC culture [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
TGF-beta level measurement with polymerase chain reaction method
IFN-gamma level in WBC culture [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
IFN-gamma level measurement with polymerase chain reaction method

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis B
Vaccination Failure

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: Atorvastatin
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

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01548326

Other Study ID Numbers ^ICMJE

behdasht-90-6-16, IRCT201109147556N1

Has Data Monitoring Committee

Yes

Responsible Party

Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University

Study Sponsor ^ICMJE

Nematollah Jonaidi Jafari

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Nematollah Jonaidi Jafari, MD

Baqiyatallah University of Medical Sciencesc

Information Provided By

Baqiyatallah Medical Sciences University

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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