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.
In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, will comprise the basis for the regulatory submissions in the U.S., Europe, and Canada, expected to begin in the second half of 2020.
Sci-B-Vac is approved for use and commercially-available in Israeli.
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; and Safety: No new or unexpected safety signals seen with either study vaccine.
On November 23, 2020, Jeff Baxter, President & CEO, stated in a press release: “We believe our 3-antigen prophylactic hepatitis B vaccine has the potential to be an important intervention in the fight to eliminate Hepatitis B infections, and this MAA submission is a significant milestone for the product and VBI more generally."
Sci-B-Vac recently completed its Phase 3 program in the U.S., Europe, and Canada. Last Update Posted: November 9, 2020.
“The completion of the BLA submission is a significant milestone for us as we work to provide access to our 3-antigen hepatitis B vaccine for adults in the U.S.,” added Jeff Baxter, President & CEO, on December 1, 2020. “In the U.S., hepatitis B infection persists as a public health threat, with increased rates of acute infection in recent years and estimates of up to 2.2 million chronically-infected individuals throughout the country. We look forward to working with the FDA during the review process as we seek marketing approval in the U.S., and we remain committed public health partners in the fight to eliminate hepatitis B.”
On February 2, 2021, the U.S. FDA accepted the Biologics License Application filing.
Massachusetts-based VBI Vaccines Inc. (VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
Sci-B-Vac Vaccine Indication
Sci-B-Vac is indicated to prevent 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. It can be administered at lower doses than competing hepatitis B vaccines, says the company.
Sci-B-Vac Vaccine News
March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter, and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021, which included December 2020 and February 2021: EMA acceptance of MAA filing, and FDA acceptance of BLA filing, initiating the review process; December 2020: Announcement of Syneos Health (Syneos) and VBI partnership for commercialization in the U.S., Europe, and Canada, pending regulatory approvals; November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) target action date set by FDA.
February 2, 2021 - VBI Vaccines Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted its filing of the Biologics License Application for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The FDA has set a Prescription Drug User Fee Act target action date of November 30, 2021. The BLA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – and other relevant data. Additionally, in the filing notification letter, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
January 15, 2021 - VBI Vaccines Inc. announced that results from a Phase 4 study of VBI’s prophylactic 3-antigen Hepatitis B virus (HBV) vaccine in younger adults were published Vaccine, a journal publication from Elsevier. The study was designed to evaluate VBI’s 3-antigen HBV vaccine's immunogenicity in support of that batch's qualification as a new reference standard for vaccine release to the Israeli market, where VBI’s vaccine is available as Sci-B-Vac®.
January 13, 2021 - Study: Rapid and high seroprotection rates achieved with a tri-antigenic Hepatitis B vaccine in healthy young adults: Results from a Phase IV study. Highlights; Peak immune response was achieved one month after the third vaccination; TAV may enhance immunogenicity in adults with typically poor or delayed response to second-generation vaccines.
December 7, 2020 - VBI Vaccines Inc. and Syneos Health announced a partnership to commercialize VBI’s 3-antigen prophylactic hepatitis B (HBV) vaccine in the United States, Europe, and Canada, pending regulatory approvals.
December 1, 2020 - VBI Vaccines Inc. announced the submission of a Biologics License Application to the U.S. FDA seeking approval of the Company’s 3-antigen prophylactic hepatitis B vaccine candidate prevention infection caused by all known subtypes of the hepatitis B virus in adults.
November 23, 2020 - VBI Vaccines Inc. announced the submission of a Marketing Authorization Application to the European Medicines Agency for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval to prevent infection caused by all known subtypes of the hepatitis B virus in adults.
November 13, 2020 - VBI announced the presentation of its abstract featuring data from one of the pivotal Phase 3 studies (PROTECT) evaluating Sci-B-Vac®, the company’s 3-antigen prophylactic hepatitis B vaccine, in an e-poster presentation at the American Association for the Study of Liver Diseases – The Liver Meeting.
October 26, 2020 - VBI Vaccines announced the presentation of two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, in e-poster presentations at ID Week 2020. Across both the PROTECT and CONSTANT registrational Phase 3 studies, Sci-B-Vac safely elicited higher anti-HBs titers in all study subjects than Engerix-B, a single antigen HBV vaccine, regardless of age, gender, or underlying comorbidity.
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 aged 18-45, met both 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 - Last Update Posted: July 17, 2020.
PROTECT is a double-blind, two-arm, randomized, controlled study that enrolled 18 years of age and older subjects. 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 - Last Update Posted: November 9, 2020.
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.