Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Exclusion Criteria

• •Previous receipt of any hepatitis B vaccine
• •History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
• •History of autoimmune disorder
• •History of sensitivity to any component of study vaccines
• •Has received the following prior to the first injection:
• •1. Within 28 days:
• •* Any vaccine
• •* Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
• •* Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
• •* Any other investigational medicinal agent
• •2. Within 90 days: Blood products or immunoglobulin
• •3. At any time: An injection of DNA plasmids or oligonucleotide
• •If female: Pregnant, nursing, or planning to become pregnant during the trial
• •Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
• •Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments