Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.

Official Title
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A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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A subject must meet all of the following criteria to be eligible for the trial: Inclusion Criteria: Be 18-70 years of age, inclusive Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28. Able and willing to provide informed consent A subject with any one of the following criteria is not eligible for the trial: Exclusion Criteria: Previous receipt of any hepatitis B vaccine History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV History of autoimmune disorder History of sensitivity to any component of study vaccines Has received the following prior to the first injection: Within 28 days: Any vaccine Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication 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 At any time: An injection of DNA plasmids or oligonucleotide If female: Pregnant, nursing, or planning to become pregnant during the trial 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 Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPLISAV<br>0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV. | Biological: HEPLISAV<br>* Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24<br>* Other names: HEPLISAV-B;|
| Active Comparator: Engerix-B<br>1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B. | Biological: Engerix-B<br>* Intramuscular injections at Week 0, Week 4, and Week 24<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 |
| --- | --- | --- |
| Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology. | Week 56 | 
| Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response | Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B | Week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and Control, Healthy, Healthy volunteers