Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects
11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been
consented and screened, they will receive a total of two injections over a 28-day period,
with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by
occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic
reactogenicity.

Comparison: This study does not include a control treatment; all subjects will receive
treatment with HEPLISAV™.

Inclusion Criteria:

- Willing and able to give written informed consent

- Women of childbearing potential must be willing to consistently use a highly effective
method of birth control

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Any previous HBV infection

- Previous vaccination (1 or more doses) with any HBV vaccine

- Any previous autoimmune diseases

- Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human
Immunodeficiency Virus (HIV)

- Received any blood products or antibodies within 3 months prior to study entry

- Ever received an injection with DNA plasmids or oligonucleotides

- Received any vaccines within 4 weeks prior to study entry

- Received any other investigational medicinal agent within 4 weeks prior to study entry