Back to resultsEffects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Primary Purpose
Hepatitis B, Vaccination Failure
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis
Eligibility Criteria
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
Sites / Locations
- Baqiyatallah University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change from baseline in serum HBsAb level
HBsAb level in serum measurement with quantitative ELIZA method
Secondary Outcome Measures
IL-4 level in WBC culture
IL-4 level measurement with polymerase chain reaction method
IL 17 level in WBC culture
IL 17 level measurement with polymerase chain reaction method
TGF-beta level in WBC culture
TGF-beta level measurement with polymerase chain reaction method
IFN-gamma level in WBC culture
IFN-gamma level measurement with polymerase chain reaction method
Full Information
NCT ID
NCT01548326
First Posted
February 27, 2012
Last Updated
March 6, 2012
Sponsor
Nematollah Jonaidi Jafari
1. Study Identification
Unique Protocol Identification Number
NCT01548326
Brief Title
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Official Title
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nematollah Jonaidi Jafari
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Vaccination Failure
Keywords
Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
one 40 mg Atorvastatin tablet orally per day for 10 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one Placebo tablet orally per day for 10 days
Primary Outcome Measure Information:
Title
Change from baseline in serum HBsAb level
Description
HBsAb level in serum measurement with quantitative ELIZA method
Time Frame
1 month after vaccination
Secondary Outcome Measure Information:
Title
IL-4 level in WBC culture
Description
IL-4 level measurement with polymerase chain reaction method
Time Frame
1 month after vaccination
Title
IL 17 level in WBC culture
Description
IL 17 level measurement with polymerase chain reaction method
Time Frame
1 month after vaccination
Title
TGF-beta level in WBC culture
Description
TGF-beta level measurement with polymerase chain reaction method
Time Frame
1 month after vaccination
Title
IFN-gamma level in WBC culture
Description
IFN-gamma level measurement with polymerase chain reaction method
Time Frame
1 month after vaccination
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nematollah Jonaidi Jafari, MD
Organizational Affiliation
Baqiyatallah University of Medical Sciencesc
Official's Role
Study Chair
Facility Information:
Facility Name
Baqiyatallah University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
We'll reach out to this number within 24 hrs