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

This is an interventional prevention trial for End Stage Renal Disease focused on measuring end stage renal failure, renal failure, kidney failure, kidney failure, chronic, chronic kidney failure, hepatitis B virus (HBV) vaccine, hepatitis B vaccine, hepatitis B, hepatitis, HBV, prevention and control, dialysis Read More

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.