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. And Sci-B-Vac is commercially available in Israeli and in 14 other countries.
VBI's Vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus. In addition, 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.
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 two vaccinations (day 168) and more than 3x after three vaccinations (day 196); Rapid Onset of Seroprotection: After two 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.
"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.
Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer, commented in a press release issued on Oct 13, 2021, "We are pleased to have the results of the CONSTANT study published in The JAMA Network Open. We continue to work with regulatory bodies in North America and Europe to support their review of our marketing authorization applications, as we believe this vaccine candidate has the potential to enhance healthcare providers' efforts to prevent the spread of HBV infection."
Massachusetts-based VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.
Sci-B-Vac Vaccine Indication
HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
Sci-B-Vac is indicated to prevent hepatitis B in adults 18 and older. On October 12, 2021, the JAMA Network published an Original Investigation: Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs. a Single-Antigen Hepatitis B Vaccine, phase 3 study. It found the 3-antigen HBV vaccine had higher seroprotection rates after the second and third vaccinations than the single-antigen HBV vaccine.
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. In addition, it can be administered at lower doses than competing hepatitis B vaccines, says the Company.
Sci-B-Vac Vaccine Side Effects
The safety and tolerability seen in this phase 3 study support the safety profile of VBI's 3-antigen vaccine candidate – with no safety signals observed in either study arm and no new safety risks identified.
Sci-B-Vac Vaccine News
October 13, 2021 - VBI Vaccines Inc. announced that results from the pivotal Phase 3 study, CONSTANT, of VBI's prophylactic 3-antigen HBV vaccine candidate in adults age 18-45 were published in The Journal of the American Medical Association Network Open on Oct. 12, 2021. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI's 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.
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 in 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 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
Sci-B-Vac Vaccine has been tested in several clinical trials as well as a Phase 4 post-marketing clinical trial.