HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD
 who are initiating or undergoing hemodialysis.
Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and
 will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the
 immunogenicity over a 20-week period and safety over a 68-week period.
Inclusion Criteria:

 -  Male and female subjects at least 18 years of age

 -  Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface
 antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to
 hepatitis B core antigen (anti-HBc) prior to first study injection

 -  Must be clinically stable and in the opinion of the investigator able to comply with
 all study procedures

 -  Must be able and willing to provide informed consent

 -  Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study
 injection

 -  Women of childbearing potential (WOCBP) must consistently use an acceptable method of
 contraception or confirm in writing she will abstain from sexual activity from the
 Screening visit through 4 weeks after the last dose of study injection. Acceptable
 birth control methods include but are not limited to oral contraceptive medication, an
 intrauterine device (IUD), an injectable contraceptive (such as medroxyprogesterone
 acetate or Depo-Provera®), a birth control patch, or a barrier method (such as condom
 or diaphragm with spermicide).

 Exclusion Criteria:

 -  Previous receipt of any hepatitis B vaccine

 -  History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or
 antibody to HIV or HCV

 -  History of sensitivity to any component of study vaccine

 -  Substance or alcohol abuse that in the opinion of the investigator would interfere
 with compliance or with interpretation of the study results

 -  Recent or ongoing history of febrile illness (within 7 days of the first study
 injection)

 -  Has received any of the following prior to the first study injection:

 -  Within 14 days:

 a. Any inactivated vaccine

 -  Within 28 days:

 1. Systemic corticosteroids (more than 3 consecutive days) or other
 immunomodulatory or immune suppressive medication with the exception of
 inhaled steroids

 2. Any live virus vaccine

 3. Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage
 colony-stimulating factor (GM-CSF)

 4. Any other investigational medicinal agent

 -  Within 90 days:

 1. Blood products or immunoglobulin

 -  If female and pregnant, nursing, or planning to become pregnant during the study

 -  Undergoing chemotherapy or expected to receive chemotherapy during the study period

 -  Has a medical condition considered by the investigator likely to interfere with the
 subject's compliance or the interpretation of study assessments, including the
 following laboratory abnormalities which the investigator may consider if severe:

 -  Anemia

 -  Thrombocytopenia

 -  Leukocytosis

 -  Neutropenia

 -  Metabolic acidosis

 -  Increased alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

 -  Hyperkalemia

 -  Hypokalemia

 -  Is scheduled to undergo a kidney transplant within 6 months of the first study
 injection