Sci-B-Vac Vaccine Description
Sci-B-Vac is a licensed, 3rd generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S, of the hepatitis B virus (“HBV”). Sci-B-Vac has demonstrated safety and efficacy in over 500,000 patients.
The Sci-B-Vac vaccine is currently approved for use in Israel and 10 other countries.
Sci-B-Vac Vaccine Indication
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.
Sci-B-Vac Vaccine Dosage
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.
January 9, 2020 - VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints; op-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®, the company’s trivalent hepatitis B (HBV) vaccine, and comparing safety and immunogenicity of Sci-B-Vac® to GlaxoSmithKline’s currently-marketed HBV vaccine, Engerix-B®. The Phase 3 study, which enrolled 2,838 adults, age 18-45 years, met both the primary and secondary endpoints.
October 16, 2018 - VBI Vaccines Completes Vaccination in PROTECT Phase 3 Clinical Study for Sci-B-Vac® Hepatitis B Vaccine.
December 2017 - VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the company to seek marketing authorization in the U.S., Europe, and Canada.
Sci-B-Vac Vaccine Clinical Trials
The two concurrent Phase III studies are PROTECT, 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.