Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Inclusion Criteria:

• Healthy volunteer without significant medical problems
• Willing to receive three doses of an FDA-approved Hepatitis B vaccine

Exclusion Criteria:

• Male or female < 18 and > 60 years of age
• Received any vaccine within a month prior to study vaccine
• History of Hepatitis B infection
• History of previous Hepatitis B vaccination(s)
• History of Hepatitis C virus (HCV) infection or positive HCV antibody test
• Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
• Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
• human immunodeficiency virus (HIV) positive
• In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
• Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
• Is pregnant or lactating
• Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
• Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
• Unable to continue participation for 30 weeks