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

February 27, 2012
March 6, 2012
September 2011
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01548326 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hepatitis B
  • Vaccination Failure
  • Drug: Atorvastatin
    one 40 mg Atorvastatin tablet orally per day for 10 days
  • Drug: placebo
    one Placebo tablet orally per day for 10 days
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
52
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01548326
behdasht-90-6-16, IRCT201109147556N1
Yes
Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University
Nematollah Jonaidi Jafari
Not Provided
Study Chair: Nematollah Jonaidi Jafari, MD Baqiyatallah University of Medical Sciencesc
Baqiyatallah Medical Sciences University
March 2012

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