Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Condition: Healthy
MeSH terms: Hepatitis B
Intervention: HEPLISAV; Engerix-B
Intervention description: Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24; Intramuscular injections at Week 0, Week 4, and Week 24
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8374.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HBV vaccine; HEPLISAV-B; Hepatitis B vaccine; Hepatitis B; Hepatitis; Hepatitis B virus (HBV); Prevention and Control; Healthy; Healthy volunteers

Summary:

      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.
    

Eligibility criteria:

        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:

               1. 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

               2. Within 90 days: Blood products or immunoglobulin

               3. 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