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

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ClinicalTrials.gov Identifier: NCT01548326
Recruitment Status : Unknown
Verified March 2012 by Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University.
Recruitment status was:  Enrolling by invitation
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated 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 : September 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in serum HBsAb level [ Time Frame: 1 month after vaccination ]
    HBsAb level in serum measurement with quantitative ELIZA method


Secondary Outcome Measures :
  1. IL-4 level in WBC culture [ Time Frame: 1 month after vaccination ]
    IL-4 level measurement with polymerase chain reaction method

  2. IL 17 level in WBC culture [ Time Frame: 1 month after vaccination ]
    IL 17 level measurement with polymerase chain reaction method

  3. TGF-beta level in WBC culture [ Time Frame: 1 month after vaccination ]
    TGF-beta level measurement with polymerase chain reaction method

  4. IFN-gamma level in WBC culture [ Time Frame: 1 month after vaccination ]
    IFN-gamma level measurement with polymerase chain reaction method


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548326


Locations
Iran, Islamic Republic of
Baqiyatallah University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Nematollah Jonaidi Jafari
Investigators
Study Chair: Nematollah Jonaidi Jafari, MD Baqiyatallah University of Medical Sciencesc
More Information

Responsible Party: Nematollah Jonaidi Jafari, Head of Health Research Center, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT01548326     History of Changes
Other Study ID Numbers: behdasht-90-6-16
IRCT201109147556N1 ( Registry Identifier: Iranian Registry of Clinical Trials )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Nematollah Jonaidi Jafari, Baqiyatallah Medical Sciences University:
Vaccination Failure
Nonresponder
Hepatitis B virus
Atorvastatin
Immunization against viral Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Atorvastatin Calcium
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors