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

Vaccines have been responsible for preventing millions of deaths and extending the average
human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes
and associated functions that bring about protective immunity. Knowledge of those genes and
cellular functions activated by effective vaccination can improve our understanding of how
the immune system works and define the features necessary for a successful vaccine response.
This study aims to define cellular functions important for the hepatitis B (HBV) vaccine
immune response in healthy individuals. The investigators will identify those genes that are
activated or suppressed in immune cells at various times after each dose of the HBV vaccine.
The investigators will explore these vaccine-induced "gene signatures" to characterize the
cellular functions associated with an effective immune response to HBV vaccination. The
investigators hypothesize that many genes associated with innate and adaptive immune
functions are important for an effective HBV vaccine response.

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