A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Hepatitis B
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Sci-B-Vac, Prophylactic vaccine, Hepatitis B vaccines, Phase 3, pre-S1, pre-S2, Surface antigen, 3-antigen
Eligibility Criteria
Inclusion Criteria:
Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs, anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)
Exclusion Criteria:
- Evidence of alcoholism or drug abuse, history of HIV, or HCV
- Blood transfusions within the three months prior to inclusion in the study
- Uncontrolled hypertension and other cardiovascular diseases
- Chronic/concurrent administration (>14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids were permitted
- History of anaphylaxis (including shock) or any significant allergy or atopy
Sites / Locations
- National Institute of Hygiene and Epidemiology (NIHE)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Sci-B-Vac-SciGen
Engerix-B
Sci-B-Vac-BTG
The 3-antigen HepB vaccine, Sci-B-Vac-SciGen (SciGen Israel Ltd., produced in a new production facility located in Rehovot, Israel) contains three recombinant proteins of hepatitis B virus (HBV) envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-SciGen was supplied in a final volume of 1.2 ml vials
The single antigen HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein. Engerix-B was supplied in 1.0 ml vials.
The 3-antigen HepB vaccine, Sci-B-Vac-BTG (Bio-Technology General (BTG) Ltd., Rehovot, Israel.) contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-BTG was supplied in a final volume of 1.2 ml vials