PreHevbrio™ Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage
PreHevbrio™ (PreHevbri®, Sci-B-Vac) is a third-generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S of the hepatitis B virus ("HBV"). PreHevbrio has demonstrated safety and efficacy in over 500,000 patients. As of April 2024, PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus, administered in three doses over six months, approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel.
In December 2017, VBI Vaccines Inc.(VBI) initiated patient dosing in a global Phase 3 clinical program with 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. During an 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. On Oct. 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.
On Feb. 2, 2021, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing. On Dec. 1, 2021, the FDA approved PreHevbrio to prevent infection caused by all known subtypes of HBV in adults. On Jan. 12, 2022, Francisco Diaz-Mitoma, M.D., Ph.D. – Chief Medical Officer, VBI, presented 'The Safety & Immunogenicity of a 3-Antigen Hepatitis B Vaccine, PreHevbri, during the U.S. CDC's Advisory Committee on Immunization Practices meeting. Then, on Feb. 23, 2022, LCDR Mark K. Weng, MD MSc, CDC Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices, presented PreHevbrio for adult hepatitis B vaccination Evidence to Recommendation and GRADE. Following a positive vote, PreHevbrio is now recommended for prophylactic adult vaccination against HBV infection.
On May 2, 2022, the Company announced that the European Commission granted Marketing Authorisation for PreHevbri for active immunization against infection caused by all known subtypes of HBV in adults. On Sept. 8, 2022, Valneva SE and VBI Vaccines Inc. announced a partnership in select European markets for the marketing and distribution of PreHevbri®. The brand names for this vaccine are PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel). In addition, on Dec. 8, 2022, Health Canada approved PreHevbrio™.
As of Mar. 22, 2024, Brii Bio secured exclusive development and commercialization rights for PreHevbri in Greater China and Asia Pacific (excluding Japan) and has submitted two pre-INDs to the CDE for PreHevbriTM's registration plan in China. A Market Authorization Application has also been filed in Hong Kong. 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.
Massachusetts-based VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs. Through its innovative approach to VLPs, including a proprietary enveloped VLP platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.
PreHevbrio Vaccine Revenues
As of May 16, 2024, PreHevbrio's global net revenue increased 105% year-over-year in the first quarter of 2024 compared to the first quarter of 2023. In the U.S., PreHevbrio sales continue to demonstrate substantial growth in early 2024, with over 80% of the 2023 full-year volume being sold in the first five months of 2024. VBI partners with Valneva SE to make PreHevbri available in certain European countries.
PreHevbrio Availability 2024
As of May 2024, PreHevbrio was available in the U.S., PreHevbri® is available in Europe (Netherlands, Belgium), the U.K., and Sci-B-Vac® in Israel. PreHevbri was approved by the European Commission and the United Kingdom Medicines and Healthcare Products Regulatory Agency in the second quarter of 2022. Valneva SE will lead marketing activities in the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in 2023. Brii Biosciences announced the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan. Availability is expected in Canada under the brand name PreHevbrio in 2024. In the U.S., PreHevbrio is available for purchase at retail pharmacy chains, including Costco, RiteAid, Walmart, and three of the top 10 regional retail pharmacy networks, as well as through the U.S. Department of Veterans Affairs, Federal Bureau of Prisons, and at certain military treatment facilities.
PreHevbrio Indication
Please visit www.PreHevbrio.com for U.S. Safety Information for PreHevbrio or U.S. Full Prescribing Information. In addition, a full European Summary of Product Characteristics for PreHevbri is available from the European Medicines Agency website. HBV infection is the leading cause of liver disease, and, with current treatments, it is challenging to cure, with many patients developing liver cancers. An estimated 900,000 people die each year from complications of chronic HBV, such as liver decompensation, cirrhosis, and hepatocellular carcinoma. The U.S. CDC. Sci-B-Vac is indicated to prevent hepatitis B in adults 18 and older. It can also be expected that hepatitis D will be controlled by immunization with PreHevbri, as hepatitis D does not occur without hepatitis B infection.
PreHevbrio Dosage
It is administered 10ug and intramuscular injection as a solution on 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.
PreHevbrio Side Effects
The safety and tolerability seen in a 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. However, do not administer PreHevbrio to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or any component of PreHevbrio. To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free), VAERS at 1-800-822-7967, or www.vaers.hhs.gov.
PreHevbrio Cost
On March 29, 2022, VBI Vaccines Inc. announced that PreHevbrio™ is now available in the U.S. at a Wholesale Acquisition Cost of $64.75/dose.
PreHevbrio News
April 16, 2024 - “Over the last 12 months, we’ve seen continued progress across all of our lead programs – with increased use of PreHevbrio and an ever-expanding access and distribution network in place, as well as positive clinical data announcements from all lead pipeline programs, we are helping to make great strides in the fight against GBM, hepatitis B, and coronaviruses,” said Jeff Baxter, VBI’s President and CEO.
July 19, 2023 - Jeff Baxter, President and CEO of VBI, commented: "We are excited to announce the launch of PreHevbri in the Netherlands and Belgium through our partnership with Valneva.
December 8, 2022 - "We are excited to announce Health Canada's approval, a fourth regulatory approval for this vaccine," said Jeff Baxter, VBI's President and CEO.
September 8, 2022 - Jeff Baxter, President and CEO of VBI, commented: "This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries."
June 1, 2022 - VBI Vaccines Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency granted marketing authorization for PreHevbri™.
May 2, 2022 - VBI Vaccines Inc. announced that the European Commission had granted Marketing Authorisation for PreHevbri™.
February 23, 2022 - VBI announced that, following a discussion at the U.S. CDC Advisory Committee meeting on Immunization Practices, PreHevbrio joined the recommended products for prophylactic adult vaccination against HBV infection.
December 1, 2021 - VBI announced that the U.S. FDA had approved PreHevbrio™.
October 26, 2020 - VBI Vaccines announced across 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.
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®.
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 and a Phase 4 post-marketing clinical trial.
June 28, 2022 - Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies of VBI's 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated the duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI's 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI's 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.
