Vaccine Info

Sci-B-Vac Hepatitis B Vaccine

Sci-B-Vac Vaccine Description

VBI Vaccines Inc.'s 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.

VBI’s enveloped virus-like particle (eVLP) platform technology enables the development of eVLPs that closely mimic the target virus to elicit a potent immune response.

During a late August 2020 presentation, Adam Finn, M.D., Ph.D., Professor of Paediatrics at the University of Bristol, UK, and principal investigator of the CONSTANT Phase 3 clinical study, discussed the successfully-met primary endpoint of CONSTANT – demonstration of the consistency of immune response as measured by the geometric mean concentration (GMC) of hepatitis B antibodies (anti-HBs titers) across three consecutively-manufactured lots of vaccine.

Additional data highlighted included:

  • High anti-HBs titers: GMC of anti-HBs for Sci-B-Vac was more than 7.5x compared to Engerix-B after 2 vaccinations (day 168) and more than 3x after 3 vaccinations (day 196)
  • Rapid Onset of Seroprotection: After 2 vaccinations, Sci-B-Vac elicited a 90.4% seroprotection rate (SPR) compared to 51.6% with Engerix-B, increasing to 99.3% vs. 94.8% after the 3rd dose
  • Safety: No new or unexpected safety signals seen with either study vaccine

Sci-B-Vac is approved for use and commercially available in Israel, and recently completed its Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B.

VBI Vaccines Inc. (VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.

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.

Sci-B-Vac Vaccine News

  • August 31, 2020 - VBI Vaccines Inc. announced the presentation of abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company’s tri-antigenic prophylactic hepatitis B (HBV) vaccine, in a late-breaker oral presentation and a poster presentation, which took place on August 27-29, 2020.

  • 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.

Updated
08/31/2020 - 08:45