Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) 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, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Detailed Description
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The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Official Title
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An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age

Conditions
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Healthy

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: be 40 - 70 years of age, inclusive be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV) be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection Exclusion Criteria: if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner has a known history of autoimmune disease has previously received any hepatitis B vaccine (approved or investigational)

Ages Eligible for Study
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Minimum Age: 40 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 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 and Week 4; placebo (saline) injection at Week 24<br>* Other names: Hepatitis B vaccine (recombinant), adjuvanted;|
| Active Comparator: Engerix-B(1)<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 Who Have a Seroprotective Immune Response | Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B® | at Week 12 and at Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local and Systemic Reaction to Injections |  | within 7 days for post-injection reactions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention & Control, HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Healthy, Healthy volunteers