Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

Detailed Description
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This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.

Official Title
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A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HEPLISAV and/or Placebo
* Biological: Engerix-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give written informed consent Is serum negative for HBV antibodies Exclusion Criteria: Women who are pregnant or breastfeeding Any previous HBV infection Previous vaccination with any HBV vaccine (1 or more doses) Any autoimmune disease 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPLISAV and/or Placebo<br>0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) | Biological: HEPLISAV and/or Placebo<br>* Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24<br>* Other names: Hepatitis B vaccine (recombinant), adjuvanted;|
| Active Comparator: Engerix-B<br>1.0 mL Engerix-B | Biological: Engerix-B<br>* Intramuscular (IM) injections on 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 With Seroprotective Immune Response | Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®) | Week 12 for HEPLISAV and Week 28 for Engerix-B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local and Systemic Reactions to Injections |  | Within 7 days post-injection for Post Injection Reactions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, Immunostimulatory sequence (ISS)