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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014