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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
  Purpose

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 Intervention Phase
Hepatitis B
Vaccination Failure
 Drug: Atorvastatin
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baqiyatallah Medical Sciences University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 52
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 27, 2012
Last Updated: March 6, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by 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
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013