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

Study Overview
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Brief Summary
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The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.

Detailed Description
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The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection

Official Title
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An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Biological: HEPLISAV
* Biological: Engerix-B
* Biological: Fendrix


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPLISAV<br>0.5 mL HEPLISAV | Biological: HEPLISAV<br>* Intramuscular (IM) injection on Day1<br>* Other names: Hepatitis B Vaccine (Recombinant), Adjuvanted;|
| Active Comparator: Engerix-B<br>2.0 mL Engerix-B | Biological: Engerix-B<br>* Intramuscular (IM) injection on Day 1<br>* Other names: Hepatitis B Vaccine (Recombinant);|
| Active Comparator: Fendrix<br>0.5 mL Fendrix | Biological: Fendrix<br>* Intramuscular (IM) injection on Day 1<br>* Other names: Hepatitis B Vaccine (Recombinant);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4 |  | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of post-injection reactions and adverse events in each treatment group |  | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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