HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Study Overview
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Brief Summary
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This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.

Detailed Description
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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.

Official Title
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An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Conditions
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End Stage Renal Disease on Dialysis (Diagnosis)

Intervention / Treatment
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* Drug: HEPLISAV-B®


Participation Criteria
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Eligibility Criteria
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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: Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids Any live virus vaccine Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) Any other investigational medicinal agent Within 90 days: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPLISAV-B®<br>A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). | Drug: HEPLISAV-B®<br>* HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of clinically significant adverse events | To evaluate the proportion of subjects with treatment-emergent medically-attended adverse events (MAEs), serious adverse events (SAEs), immune-mediated adverse events of special interest (AESIs), acute myocardial infarctions (AMIs), and deaths | Monitor for safety until Week 68 or EOS | 
| Evaluation of seroprotection rate (SPR) | To evaluate the immunogenicity induced by HEPLISAV-B® when administered according to the proposed dosing schedule, as measured by the SPR, defined as antibody to hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL | Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of immunogenicity | To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the percentage of subjects with anti-HBs concentration ≥100 mIU/mL | Weeks 4, 8, 16, 20 | 
| Evaluation of immunogenicity | To evaluate the immunogenicity induced by HEPLISAV-B® as measured by the serum anti-HBs geometric mean concentration (GMC) | Weeks 4, 8, 16, 20 | 
| Evaluation of immunogenicity | To evaluate the immunogenicity induced by HEPLISAV-B® at each study visit through 20 weeks after the first dose of study vaccine as measured by the SPR | Weeks 4, 8, 16, 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Hemodialysis, End Stage Renal Disease, Hepatitis B, HEPLISAV-B, Prevention and Control, HBV Vaccine, Hepatitis B Vaccine