Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: HEPLISAV-B; Engerix-B; Placebo
Intervention description: Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24; Intramuscular (IM) injections at Weeks 0, 4, 8, and 24; Placebo(saline) intramuscular (IM) injection at Week 8
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 521.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic kidney disease; kidney failure; kidney failure,chronic; chronic kidney failure; hepatitis B virus (HBV) vaccine; hepatitis B vaccine; hepatitis B; hepatitis; HBV; prevention and control; dialysis

Summary:

      The purpose of the study is to demonstrate the safety and immunogenicity of a new
      investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who
      have progressive loss of kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be 18 to 75 years of age;

          -  progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45
             mL/min/1.73 m²;

          -  be clinically stable in the opinion of the investigator;

          -  be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg),
             Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);

          -  if a woman of childbearing potential, agree to consistently use a highly effective
             method of birth control from screening visit through the treatment phase and for up to
             28 days after the last injection;

          -  is not scheduled to undergo a kidney transplant in the next 12 months;

          -  be able and willing to provide informed consent.

        Exclusion Criteria:

          -  if female, is pregnant, breastfeeding, or planning a pregnancy;

          -  has a history of or is considered by the investigator to be at high risk for recent
             exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has
             unprotected sex with known HBV/HIV positive partner;

          -  has known history of autoimmune disease;

          -  has previously received any HBV vaccine;

          -  has a history of sensitivity to any component of study vaccines;

          -  has current illness other than renal disease or has substance or alcohol abuse that in
             the opinion of the investigator 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 or hypertension;

          -  is unwilling or unable to comply with all the requirements of the protocol;

          -  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 first injection:

          -  3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)

          -  7 days: intravenous iron

          -  21 days: any inactivated virus vaccine

          -  28 days:

          -  any live virus vaccine

          -  systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or
             immune suppressive medication, with the exception of inhaled steroids

          -  granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other
             investigational medicinal agent

          -  At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide