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

A subject must meet all of the following criteria to be eligible for the trial: Inclusion Criteria:

• Be 18-70 years of age, inclusive

• Able to comprehend and follow all required study procedures and be available for allvisits scheduled in the study

• If a woman is of childbearing potential, she must consistently use an acceptablemethod of contraception or confirm in writing she will abstain from sexual activityfrom the Screening Visit through Week 28.

• Able and willing to provide informed consent A subject with any one of the following criteria is not eligible for the trial:

Exclusion Criteria:

• Previous receipt of any hepatitis B vaccine

• History of hepatitis B or human immunodeficiency virus (HIV) infection or positivetest for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibodyto 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 otherimmunomodulators or immune suppressive medication

• Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophagecolony-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 studyperiod; has a diagnosis of cancer within the last 5 years other than squamous or basalcell carcinoma of the skin

• Any other medical condition considered by the investigator likely to interfere withthe subject's compliance or the interpretation of study assessments