Sci-B-Vac is a licensed, third-generation hepatitis B trivalent vaccine which mimics all three surface antigens, pre-S1, pre-S2, and S, of the hepatitis B virus (“HBV”).
Sci-B-Vac is indicated for the prevention of hepatitis B in adults 18 and older. It is currently licensed for use in Israel and 10 other countries.
It is administered as a solution, 10ug, IntraMuscular injection at Days 0, 28, and 168.
Sci-B-Vac is currently in two Phase 3 clinical trials to support Sci-B-Vac licensure in the U.S., Europe, and Canada.
The two concurrent Phase III studies are PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study.
Clinical Trial NCT03393754: Immunogenicity and Safety of Sci-B-Vac™ to Engerix-B® in Adults ≥ 18 Years Old and Superiority in Adults ≥ 45 Years Old
PROTECT is a double-blind, two-arm, randomized, controlled study, that enrolled subjects 18 years of age and older. Subjects were randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10 μg or a three-dose course of the control vaccine, Engerix-B 20 μg.
Under the planned dosing schedule, subjects were vaccinated at months zero, one, and six. Enrollment was stratified by age group.
Clinical Trial NCT03408730: Lot-to-lot Consistency of Sci-B-Vac in Adults
CONSTANT is a double-blind, four-arm, randomized, controlled study. Approximately 3,200 adult subjects, age 18-45 years, will be randomized in a 1:1:1:1 ratio to receive one of four three-dose courses: Lot A of Sci-B-Vac 10μg, Lot B of Sci-B-Vac 10μg, Lot C of Sci-B-Vac 10μg, or the control vaccine Engerix-B® 20μg.