Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
Condition: Hepatitis B Vaccines
MeSH terms: Hepatitis B; Hepatitis
Intervention: Hepatitis B Vaccination
Intervention description: Prophylactic Hepatitis B Vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1607.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B Vaccines

Summary:

      This study is a double-blind randomized controlled trial designed to establish the
      non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the
      superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any gender.

          -  Age ≥ 18 years

          -  In stable health as determined by a physical examination and laboratory tests values.
             Common chronic conditions such as, but not limited to, type 2 diabetes, high blood
             pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if
             the condition is well controlled, as determined by the investigator, and not meeting
             the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3

          -  If female, either is not of childbearing potential or is of childbearing potential and
             must agree to use an adequate birth control method during the screening period and
             until the end of her participation in the study

          -  Able and willing to give consent.

        Exclusion Criteria:

          -  Previous vaccination with any Hep B vaccine (licensed or experimental).

          -  Treatment by immunosuppressant within 30 days of enrollment including but not limited
             to corticosteroids at a dose that is higher than an oral or injected physiological
             dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are
             allowed).

          -  Known history of immunological function impairment

          -  Pregnancy or breastfeeding

          -  Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment

          -  Immunization with inactivated vaccines (e.g. influenza) within 2 weeks prior to
             enrolment

          -  Has received blood products or immunoglobulin within 90 days of enrollment or is
             likely to require blood products during the study period

          -  Subject in another clinical trial with an investigational drug or a biologic within 30
             days of enrollment

          -  Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or
             erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or
             erythropoietin during the study period

          -  Any history of cancer requiring chemotherapy or radiation within 5 years of
             randomization or current disease.

          -  Any skin abnormality or tattoo that would limit post-vaccination injection site
             assessment

          -  History of allergic reactions or anaphylactic reaction to any vaccine component
             (Engerix-B® or Sci-B-Vac®)

          -  Unwilling, or unable in the opinion of the investigator, to comply with study
             requirements, including the use of an adequate birth control method

          -  Immediate family members of study center staff (parents, sibling, children)

          -  Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers
             at screening

          -  Known hepatitis C infection or positive Hepatitis C serology at screening, unless
             treated and cured

          -  Known human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening

          -  Renal impairment at screening

          -  Uncontrolled diabetes mellitus

          -  Uncontrolled hypertension

          -  Any laboratory test abnormality that would be considered of Grade 1 severity and is
             considered as clinically significant by the investigator. Grade 3 severity or above is
             exclusionary, regardless of clinical assessment.

          -  Diagnosis of advanced stage heart failure or Unstable Angina.