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

Nematollah Jonaidi Jafari

Status and phase: Unknown; Phase 4

Conditions: Vaccination Failure; Hepatitis B

Treatments: Drug: placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01548326

IRCT201109147556N1 (Registry Identifier)

behdasht-90-6-16

Details and patient eligibility

About

The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo