Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

Inclusion Criteria: * ≥ 18 years of age * Has loss of renal function and is receiving hemodialysis treatments * Is not seroprotected against hepatitis B (has anti-HBs \< 10 mIU/mL) * In the opinion of the investigator, is clinically stable * Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV * Is not scheduled to undergo a kidney transplant during the study period * If female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study. Exclusion Criteria: * If female, is pregnant, breastfeeding, or planning a pregnancy; * Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV; * Has known history of autoimmune disease; * Has history of sensitivity to any component of study vaccines; * Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results; * 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; * Has uncontrolled diabetes; * Has received a kidney transplant previously that is still functioning and requires anti-rejection medication; * Has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; * Has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF); any other investigational medicinal agent; * At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides; investigational or intradermal hepatitis B vaccine.