PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines, Brii Biosci - LARVOL DELTA

PREHEVBRIO Pregnancy Outcomes Registry (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: VBI Vaccines Inc. | N=120 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

Intradermal hepatitis B vaccination with imiquimod pretreatment in dialysis patients: a cost-effectiveness analysis. (PubMed, Cost Eff Resour Alloc) - "ID administration of HBV Sci-B-Vac with pre-treatment IMQ cream in serologically negative dialysis patients was the cost-effective strategy."

HEOR • Journal • Hepatitis B • Infectious Disease • Inflammation

A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers. (PubMed, Vaccine) - P3 | "PreHevbrio® is a 3-antigen HBV vaccine (3-A-HBV) engineered to express the three HBV envelope proteins; the small 'S' hepatitis B surface antigen (SHBs or HBsAg), the middle pre-S2 + HBsAg (MHBs) and the large PreS1 + PreS2 + HBsAg (LHBs) antigens...Further, we demonstrate that the T cell responses significantly correlate with the higher observed anti-HBs titers and may contribute to the higher and more durable anti-HBs titers. This trial is registered at Clinicaltrials.gov (NCT03393754) and EudraCT (2017-001819-36)."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Economic Evaluation of Intradermal Hepatitis B Vaccination Plus Imiquimod Pretreatment for Dialysis Patients (ISPOR-EU 2024) - "Intradermal administration of HBV Sci-B-Vac plus imiquimod pretreatment appears to be a cost-effective strategy for serologically negative dialysis patients."

Clinical • HEOR • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Longterm Outcome of Therapeutic Vaccination with a Third Generation Pre-S/S HBV Vaccine (PreHevbrioR) of Chronically HBV Infected Patients. (PubMed, J Pers Med) - "Long-term observation (>6 years) showed that after discontinuing NUC treatment for at least two years, HBsAg and HBV DNA remained negative with anti-HBs positive titers ranging between 80 and >1000 IU/L. Based on our preliminary observations, there is a rationale to further evaluate the role of this vaccine as a therapeutic agent."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

The role of new hepatitis B vaccines in South Africa. (PubMed, S Afr Med J) - "PreHevbrio, which includes three hepatitis B surface protein domains, instead of one, may also be more immunogenic, although clinical study data are still limited. These two novel vaccines have not yet been investigated in children and licensed in SA. Should HEPLISAV-B become available in SA, it may be particularly valuable to target high-risk groups in the country, such as people living with HIV, who show a poor response to the currently licensed vaccine."

Journal • Diabetes • Genetic Disorders • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Metabolic Disorders • Obesity

PREHEVBRIO Pregnancy Outcomes Registry (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: VBI Vaccines Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

PreHevbrio: the first approved 3-antigen hepatitis B vaccine. (PubMed, Expert Rev Vaccines) - "3A-HBV provides higher seroprotection rates after each vaccination compared to conventional 1A-HBV vaccines, allowing for more rapid protection. The higher overall immunogenicity is also reflected in more durable seroprotection years after vaccination, as supported by a follow-up study to one of the phase 3 studies."

Journal • Review • Diabetes • Genetic Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

PREHEVBRIO Pregnancy Outcomes Registry (clinicaltrials.gov) - P=N/A | N=120 | Not yet recruiting | Sponsor: VBI Vaccines Inc.

New trial

VBI Vaccines Announces Pricing of $18 Million Public Offering and $3 Million Concurrent Registered Direct Offering (Businesswire) - "VBI Vaccines Inc...today announced the pricing of its previously announced underwritten public offering of 10,909,091 common shares and accompanying common warrants to purchase up to 10,909,091 common shares, and its concurrent registered direct offering of 1,818,182 common shares and accompanying common warrants to purchase up to 1,818,182 common shares, at a combined public offering price of $1.65 per share and accompanying common warrant...The offerings are expected to close on or about July 10, 2023, subject to satisfaction of customary closing conditions...VBI intends to use the net proceeds from both offerings for the commercialization activities for PreHevbrio® [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses)."

Commercial • Pricing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hepatitis B • Novel Coronavirus Disease • Oncology • Solid Tumor

T-cell responses to PreS1 and PreS2 are correlated to anti-HBs antibody titres, which are higher and persist longer in volunteers vaccinated with 3-antigen than with 1-antigen hepatitis B vaccine in the PROTECT Study:3.5 year follow up (EASL-ILC 2023) - "Background and Aims: PreHevbri is a 3-antigen hepatitis B vaccine containing S, PreS1 and PreS2 HBV envelope antigens and Engerix is a 1-antigen HBV vaccine containing the S Ag. The 3-antigen Hepatitis B vaccine induces T-cell responses to the PreS domains that are correlated to high and persistent anti-HBs titers observed in the follow up extension of PROTECT Phase 3 study. Anti-HBs >100 mIU/mL at 3.5 years of follow up post 3rd vaccination were almost double with 3-antigen than the 1-antigen hepatitis B vaccine. Figure: YI bursary request: No Plagia Similarity: Status: Comments: Source: Average Grade: 10.2 Reviewing Comments: Average score value: Comment: Suggested type: Rejection Suggested: Reason for rejection: Comment for rejection: :"

Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD4 • IFNG

VBI Vaccines and Brii Biosciences Expand Hepatitis B Partnership To Address Both Prevention and Treatment in License and Collaboration Agreements for up to $437 Million Plus Royalties (Businesswire) - "VBI Vaccines...announced the expansion of its hepatitis B (HBV) partnership with Brii Biosciences....Through two license and collaboration agreements, Brii Bio expanded its exclusive license to VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, to global rights and acquired an exclusive license for PreHevbri, VBI’s 3-antigen hepatitis B vaccine, in the Asia Pacific region (APAC)....As part of the collaborations, Brii Bio will pay VBI an upfront payment of $15 million, including an equity investment of approximately $3 million, contingent on achievement of near-term milestones. VBI is also eligible to receive up to an additional $422 million in potential regulatory and commercial milestone payments, and potential double-digit royalties in the licensed territories, which is worldwide for VBI-2601 and APAC, excluding Japan, for PreHevbri."

Financing • Licensing / partnership • Hepatitis B • Infectious Disease

VBI Vaccines Announces Proposed Concurrent Public Offering and Registered Direct Offering of Common Shares and Warrants (Businesswire) - "VBI Vaccines...announced that it has commenced an underwritten public offering and a registered direct offering of its common shares and accompanying common warrants to purchase its common shares....VBI intends to use the net proceeds from both offerings for the commercialization activities for PreHevbrio® [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses)."

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hepatitis B • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor

The persistence of seroprotective levels of antibodies after vaccination with PreHevbrio, a 3-antigen hepatitis B vaccine. (PubMed, Vaccine) - "After 2.5 years, more 3A-HBV subjects remained seroprotected (88.1 % [95 %CI: 84.1,92.2]) versus 1A-HBV (72.4 % [95 %CI: 66.6,78.3)], p < 0.0001) and had higher mean anti-HBs [1382.9 mIU/mL (95 %CI: 1013.8,1751.9) versus 252.6 mIU/mL (95 %CI: 127.5,377.6), p < 0.0001]. In multiple variable logistic regression analysis including age, vaccine, initial vaccine response, sex and BMI, only higher post dose 3 (Day 196) antibody titers significantly reduced the odds of losing seroprotection."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Cost-effectiveness of a 3-antigen versus single-antigen vaccine for the prevention of hepatitis B in adults in the United States. (PubMed, Vaccine) - P3 | "The recently approved 3-antigen vaccine is a cost-saving or cost-effective intervention for preventing HBV infection and addressing the long-standing burden of hepatitis B among US adults."

Cost effectiveness • HEOR • Journal • Diabetes • Genetic Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders • Obesity

[VIRTUAL] Higher proportion of responders with hepatitis B antibody levels >=100 miu/ml with the trivalent HepB vaccine, Sci-B-Vac, compared to Engerix-B: results from the phase 3 double-blind, randomized study comparing immunogenicity and safety (PROTECT) (EASL-ILC-I 2020) - P3 | "Sci-B-Vac® yielded a more robust immune response, reflected in high GMC ratios, compared to Engerix B® and met both co-primary immunogenicity endpoints — non- inferiority in adults ≥ 18 years and superiority in adults ≥ 45 years. Safety and tolerability were consistent with the known profile of Sci-B-Vac®."

Clinical • P3 data • Hepatitis B • Hepatology • Infectious Disease

[VIRTUAL] High HBsAb titres consistent across 3 lots of the trivalent HepB vaccine, Sci-B-Vac: Results from the second pivotal phase 3 double-blind, randomised controlled trial designed to assess the lot-to-lot consistency of Sci-B-Vac in adults (CONSTANT) (EASL-ILC-I 2020) - P3 | "Sci-BVac® is a trivalent HepB vaccine (TV), containing S, pre-S1, and pre-S2 antigens, that has shown enhanced seroprotection rates (SPR) in adult populations when compared to monovalent vaccines (MV), such as Engerix-B®. TV met both the primary and secondary endpoints of the study. In this second pivotal Phase 3 study, TV continued to demonstrate its ability to safely and quickly elicit robust immune responses in adults."

Clinical • P3 data • Hepatitis B • Hepatology • Infectious Disease • Pain

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Pneumococcal Infections • Respiratory Diseases • Tetanus • Varicella Zoster

Expanded table: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Pertussis • Respiratory Diseases • Tetanus • Varicella Zoster

PreHevbrio: A New 3-Antigen Hepatitis B Vaccine for Adults. (PubMed, Ann Pharmacother) - "The 3A-HepB represents another vaccine to prevent hepatitis B in adults. It is safe and immunogenic but is associated with more adverse reactions than 1A-HepB."

Journal • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Musculoskeletal Pain • Pain

A three-antigen hepatitis B vaccine (PreHevbrio). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

VBI Vaccines Announces PreHevbrio is Now Available in the United States for the Prevention of Hepatitis B in Adults (BioSpace) - "VBI Vaccines...today announced that PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older....VBI is working with a network of wholesalers, distributors, group purchasing organizations, and federal accounts to enable broad access to PreHevbrio, and the Company expects to further build out this network in the coming weeks. The Wholesale Acquisition Cost (WAC) for PreHevbrio has been set at $64.75 per dose..."

Launch US • Hepatitis B • Infectious Disease

VBI Vaccines Reports Fourth Quarter and Full Year Financial Results for 2021, Provides Corporate Update and Outlook for 2022 (Businesswire) - "VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate...H2 2022: Initial data from Phase 2 combination study expected...H1 2023: Initial data from the Phase 2a/2b 'add-on' study expected...Research and Development (R&D): R&D expenses for the full year 2021 were $19.6 million compared to $14.9 million for the same period in 2020. The increase in R&D spend was mainly a result of the increase in costs related to the continued development of our eVLP vaccine candidates and increased regulatory costs related to our 3-antigen HBV vaccine."

Commercial • P2 data • P2a data • P2b data • Hepatitis B • Infectious Disease

VBI Vaccines Receives Positive CHMP Opinion for 3-Antigen Hepatitis B Vaccine for Immunization Against Hepatitis B Infection in Adults in the European Union (VBI Vaccines Press Release) - "VBI Vaccines Inc...announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for VBI’s 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)]. The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults...The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for PreHevbri in the EU is expected in the coming months....The CHMP’s positive opinion was supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data."

European regulatory • Hepatitis B • Infectious Disease

VBI Vaccines Announces PreHevbrio [Hepatitis B Vaccine (Recombinant)] Recommended by CDC Advisory Committee on Immunization Practices for the Prevention of Hepatitis B in Adults (VBI Vaccines Press Release) - "Vaccine availability is expected to begin later in Q1 2022; VBI Vaccines Inc...announced that, following discussion at this afternoon’s meeting of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] now joins the list of recommended products for prophylactic adult vaccination against hepatitis B (HBV) infection."

Launch US • Reimbursement • Hepatitis B • Infectious Disease