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

NCT ID: NCT01548326

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B Vaccination Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

one 40 mg Atorvastatin tablet orally per day for 10 days

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one Placebo tablet orally per day for 10 days

Interventions

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Atorvastatin

one 40 mg Atorvastatin tablet orally per day for 10 days

Intervention Type DRUG

placebo

one Placebo tablet orally per day for 10 days

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nematollah Jonaidi Jafari

OTHER

Sponsor Role lead

Responsible Party

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Nematollah Jonaidi Jafari

Head of Health Research Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nematollah Jonaidi Jafari, MD

Role: STUDY_CHAIR

Baqiyatallah University of Medical Sciencesc

Locations

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Baqiyatallah University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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IRCT201109147556N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

behdasht-90-6-16

Identifier Type: -

Identifier Source: org_study_id

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