Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Condition: Hepatitis B Vaccines
MeSH terms: Hepatitis B; Hepatitis
Intervention: Hepatitis B Vaccination
Intervention description: Hepatitis B Vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2838.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B Vaccines

Summary:

      A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any gender

          -  Age 18-45 years

          -  Healthy, as determined by a physical examination and values of laboratory tests

          -  If female, either is not of childbearing potential, defined as postmenopausal for at
             least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy
             or hysterectomy), is of childbearing potential and must agree to use an adequate birth
             control method

          -  Able and willing to give informed consent

        Exclusion Criteria:

          -  Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)

          -  Treatment by immunosuppressant within 30 days of enrollment

          -  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 week 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

          -  Unwilling, or unable in the opinion of the investigator, to comply with study
             requirements

          -  Immediate family members of study center staff

          -  Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers

          -  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 with Glomerular Filtration Rate (GFR) <90 mL/min/ 1.73 m2 at
             screening

          -  BMI ≥ 35

          -  Uncontrolled hypertension

          -  Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening

          -  Any laboratory test abnormality that would be considered of Grade 1 severity or above
             as per FDA guidelines for grading clinical laboratory abnormalities and is considered
             as clinically significant by the investigator.