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

A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)

A Controlled Trial to Assess the 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.