Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

Detailed Description
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This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

Official Title
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An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HEPLISAV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give written informed consent Women of childbearing potential must be willing to consistently use a highly effective method of birth control Exclusion Criteria: Women who are pregnant or breastfeeding Any previous HBV infection Previous vaccination (1 or more doses) with any HBV vaccine Any previous autoimmune diseases Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) Received any blood products or antibodies within 3 months prior to study entry Ever received an injection with DNA plasmids or oligonucleotides Received any vaccines within 4 weeks prior to study entry Received any other investigational medicinal agent within 4 weeks prior to study entry

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPLISAV<br>0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL | Biological: HEPLISAV<br>* Intramuscular (IM) injections 0.5mL on Day 0 and Week 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Local and Systemic post-injection reactions. | Within 7 days post-injection for post-injection reactions at Week 0 and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | Seroprotective Immune Response | Weeks 4, 8, 12 and 28 | 
| Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Measurement of Serum GMC | Weeks 4, 8, 12, and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg