Lot-to-lot Consistency of Sci-B-Vac™ in Adults

The primary objective of the study is to verify that the manufacturing equivalence of
Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen
of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.

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.