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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548326

Enrollment

Registered

2012-03-08

Start date

2011-09-30

Completion date

2012-07-31

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Vaccination Failure

Keywords

Vaccination Failure, Nonresponder, Hepatitis B virus, Atorvastatin, Immunization against viral Hepatitis

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.

Interventions

DRUGAtorvastatin

one 40 mg Atorvastatin tablet orally per day for 10 days

DRUGplacebo

one Placebo tablet orally per day for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in serum HBsAb level	1 month after vaccination	HBsAb level in serum measurement with quantitative ELIZA method

Secondary

Measure	Time frame	Description
IL-4 level in WBC culture	1 month after vaccination	IL-4 level measurement with polymerase chain reaction method
IL 17 level in WBC culture	1 month after vaccination	IL 17 level measurement with polymerase chain reaction method
TGF-beta level in WBC culture	1 month after vaccination	TGF-beta level measurement with polymerase chain reaction method
IFN-gamma level in WBC culture	1 month after vaccination	IFN-gamma level measurement with polymerase chain reaction method

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026