Preservation and Transfer of Hepatitis B Virus Immunity After Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients (Protect Study)

Sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will probably preserve their immune response to vaccinations administered prior to the transplantation and will therefore not need to be revaccinated. Furthermore, SCD patients after haploidentical HSCT might benefit from adoptive transfer of immunity from their donors.
To test the first hypothesis, patients undergoing alemtuzumab/TBI HSCT will be vaccinated with a hepatitis B virus (HBV) vaccine before the transplant. To test the second hypothesis, haploidentical and matched related donors will be vaccinated prior to stem cell donation against HBV. Neither the patient nor the donor may previously have been immunized against HBV in all cohorts. Post-transplantation, the investigators will be able to evaluate whether SCD patients preserve their pre-transplant immune response in the post-transplantation period. Furthermore, the investigators will determine whether donors transfer their immunity to HSCT recipients with SCD disease.

Start Date08 Jun 2021

Sponsor / Collaborator

Academic Medical Center University of Amsterdam

NCT04193189

/ CompletedPhase 3IIT

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.

Start Date14 Dec 2020

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT04398706

/ CompletedPhase 2

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Primary objectives:
* To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection).
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8)
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8)
Secondary objectives:
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8)
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8)
* In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel
* In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX])

Start Date22 May 2020

Sponsor / Collaborator

Sanofi Pasteur

100 Clinical Results associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

100 Translational Medicine associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

100 Patents (Medical) associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

370

Literatures (Medical) associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

19 Jul 2024·Cureus

Measuring Immunoglobulin Titers Among Healthcare Workers After Hepatitis B Vaccination: A Cross-Sectional Study in Kuwait

Article

Author: Eltawansy, Marwa ; Gomaa, Alshaimaa ; Sanhoury, Marwa ; Sheha, Marwa ; Elshony, Sahar ; Alkhaldi, Sarah ; Alqabandi, Sarah ; Khafagi, Walaa ; Alfaresi, Shaikhah ; Alenzi, Farah ; Aldousari, Hussah

Introduction Hepatitis B virus (HBV) is a highly infectious disease affecting the liver, causing life-threatening acute and chronic hepatitis. It poses a significant global public health burden and is a major occupational risk for healthcare workers (HCWs) due to transmission through blood and blood products. Given their increased risk compared to the general population, vaccination is crucial in limiting the spread of HBV and protecting HCWs. This study aims to measure the anti-HBs titers of HCWs in the Farwaniyah Health District in Kuwait after completing three doses of the HBV vaccine. Methods This cross-sectional study was conducted in the Farwaniyah Health District of Kuwait between May and July 2023. We collected data from 556 participants from various departments, including physicians, nurses, and laboratory technicians, chosen through simple random sampling. Inclusion criteria included the completion of three doses of the HBV vaccine (Engerix-B recombinant vaccine, GlaxoSmithKline Biologicals, Brentford, UK). Demographic data were collected, and blood samples were tested for hepatitis B surface antigen antibody titers using fourth-generation enzyme-linked immunosorbent assay. Participants were categorized based on sex, age, specialty, and time since the last vaccine dose. The chi-square test and Fisher's exact test assessed differences in categorical variables, with a p-value of <0.05 considered statistically significant. Results The study included 556 participants, with 304 (54.7%) women and 252 (45.3%) men. Participants were assigned into two age groups: 294 (52.9%) were 18 to 40 years old and the remainder (262) were over 40. Most participants were nursing staff (n=392; 70.5%), followed by physicians (n=110; 19.7%) and technicians (n=54; 9.7%). A high proportion (n=340; 61.2%) received their last vaccine dose within the last five years. Overall, 375 (67.4%) HCWs developed sufficient anti-HBs titers of ≥100 mIU/mL while 181 (32.6%) had levels below 100 mIU/mL. Age between 18 and 40 years and receiving the vaccine within the last five years were significantly associated with protective titer levels, while sex was not. Nurses had significantly higher immunity levels compared to doctors and technicians. Conclusions HCWs in the Farwaniyah area of Kuwait generally responded positively to the HBV vaccine. Younger HCWs and those who received the vaccine more recently were more likely to have a protective immune response. Nurses demonstrated higher rates of seroconversion compared to doctors and technicians. These results suggest that HBV vaccination programs should prioritize timely booster doses, especially for older HCWs and those vaccinated long ago. Monitoring antibody levels is crucial to ensure ongoing protection, particularly in high-risk groups such as nurses. Implementing these measures can enhance the effectiveness of HBV vaccination programs, reduce HBV incidence among HCWs, and contribute to a safer healthcare environment. Post-vaccination testing is essential to ensure the safety of all HCWs against HBV.

01 Jul 2024·The Lancet Infectious Diseases

Safety and immunogenicity of the co-administered Na-APR-1 and Na-GST-1 hookworm vaccines in school-aged children in Gabon: a randomised, controlled, observer-blind, phase 1, dose-escalation trial

Article

Author: Kremsner, Peter G ; Vodonou, Kafui G ; Bethony, Jeffrey M ; Adegnika, Ayola A ; Edoa, Jean Ronald ; Massinga Loembe, Marguerite ; Diemert, David J ; Bottazzi, Maria Elena ; Li, Guangzhao ; Adégbité, Bayodé R ; Hotez, Peter J ; Honkpehedji, Yabo Josiane ; Bikangui, Rodrigue ; Yazdanbakhsh, Maria ; van Leeuwen, Remko ; Zinsou, Jeannot F ; Dejon-Agobé, Jean Claude ; Grobusch, Martin P

BACKGROUNDA human hookworm vaccine is being developed to protect children against iron deficiency and anaemia associated with chronic infection with hookworms. Necator americanus aspartic protease-1 (Na-APR-1) and N americanus glutathione S-transferase-1 (Na-GST-1) are components of the blood digestion pathway critical to hookworm survival in the host. Recombinant Na-GST-1 and catalytically inactive Na-APR-1 (Na-APR-1[M74]) adsorbed to Alhydrogel were safe and immunogenic when delivered separately or co-administered to adults in phase 1 trials in non-endemic and endemic areas. We aimed to investigate the safety and immunogenicity of these antigens in healthy children in a hookworm-endemic area.METHODSThis was a randomised, controlled, observer-blind, phase 1, dose-escalation trial, conducted in a clinical research centre, in 60 children aged six to ten years in Lambaréné, a hookworm-endemic region of Gabon. Healthy children (determined by clinical examination and safety laboratory testing) were randomised 4:1 to receive co-administered Na-GST-1 on Alhydrogel plus Na-APR-1(M74) on Alhydrogel and glucopyranosyl lipid A in aqueous formulation (GLA-AF), or co-administered ENGERIX-B hepatitis B vaccine (HBV) and saline placebo, injected into the deltoid of each arm. Allocation to vaccine groups was observer-masked. In each vaccine group, children were randomised 1:1 to receive intramuscular injections into each deltoid on two vaccine schedules, one at months 0, 2, and 4 or at months 0, 2, and 6. 10 μg, 30 μg, and 100 μg of each antigen were administered in the first, second, and third cohorts, respectively. The intention-to-treat population was used for safety analyses; while for immunogenicity analyses, the per-protocol population was used (children who received all scheduled vaccinations). The primary outcome was to evaluate the vaccines' safety and reactogenicity in healthy children aged between six and ten years. The secondary outcome was to measure antigen-specific serum IgG antibody levels at pre-vaccination and post-vaccination timepoints by qualified ELISAs. The trial is registered with ClinicalTrials.gov, NCT02839161, and is completed.FINDINGSBetween Jan 23 and Oct 3, 2017, 137 children were screened, of whom 76 were eligible for this trial. 60 children were recruited, and allocated to either 10 μg of the co-administered antigens (n=8 for each injection schedule), 30 μg (n=8 for each schedule), 100 μg (n=8 for each schedule), or HBV and placebo (n=6 for each schedule) in three sequential cohorts. Co-administration of the vaccines was well tolerated; the most frequent solicited adverse events were mild-to-moderate injection-site pain, observed in up to 12 (75%) of 16 participants per vaccine group, and mild headache (12 [25%] of 48) and fever (11 [23%] of 48). No vaccine-related serious adverse events were observed. Significant anti-Na-APR-1(M74) and anti-Na-GST-1 IgG levels were induced in a dose-dependent manner, with peaks seen 14 days after the third vaccinations, regardless of dose (for Na-APR-1[M74], geometric mean levels [GML]=2295·97 arbitrary units [AU] and 726·89 AU, while for Na-GST-1, GMLs=331·2 AU and 21·4 AU for the month 0, 2, and 6 and month 0, 2, and 4 schedules, respectively). The month 0, 2, and 6 schedule induced significantly higher IgG responses to both antigens (p=0·01 and p=0·04 for Na-APR-1[M74] and Na-GST-1, respectively).INTERPRETATIONCo-administration of recombinant Na-APR-1(M74) and Na-GST-1 to school-aged Gabonese children was well tolerated and induced significant IgG responses. These results justify further evaluation of this antigen combination in proof-of-concept controlled-infection and efficacy studies in hookworm-endemic areas.FUNDINGEuropean Union Seventh Framework Programme.

01 Apr 2024·Kidney International Reports

A Randomized Controlled Study of Efficacy and Safety of Accelerated Versus Standard Hepatitis B Vaccination in Patients With Advanced CKD

Article

Author: Kittrakulrat, Jathurong ; Kerr, Stephen J ; Townamchai, Natavudh ; Tungsanga, Somkanya ; Wattanatorn, Salin ; Chaiteerakij, Roongruedee ; Avihingsanon, Yingyos ; Praditpornsilpa, Kearkiat ; Eiam-Ong, Somchai ; Tiranathanagul, Khajohn ; Tiankanon, Kanitha ; Udomkarnjananun, Suwasin ; Vanichanan, Jakapat

IntroductionHepatitis B virus (HBV) vaccination is crucial for seronegative patients with advanced chronic kidney disease (CKD) for protection during dialysis while preparing for transplantation. A standard regimen for HBV vaccination requires 24 weeks to be completed. An accelerated HBV vaccination regimen completed within 8 weeks has shown early effective seroconversion in healthcare workers. However, data for patients with advanced CKD are limited.MethodsA randomized controlled trial was conducted in patients with advanced CKD (estimated glomerular filtration rate [GFR] <30 ml/min per 1.73 m²) and patients on dialysis. The patients were randomly assigned to either a standard HBV vaccination regimen (Engerix B; 40 μg at 0, 4, 8, and 24 weeks) or an accelerated regimen (40 μg at 0, 1, 4, and 8 weeks). The hepatitis B surface antibodies (anti-HBs) were measured at 12, 28, and 52 weeks. Seroconversion were defined as anti-HBs ≥10 IU/l.ResultsAt 12 weeks, among the intention-to-treat (ITT) population of 133 participants (65 in the accelerated and 68 in the standard groups), the accelerated group demonstrated significantly higher rates of seroconversion (83.08% vs. 63.24%, P = 0.01). In the per-protocol (PP) analysis of 125 patients (62 in the standard and 63 in the accelerated groups), the accelerated group exhibited higher seroconversion rate compared with the standard group (85.71% vs. 69.35%, P = 0.03). At 28 and 52 weeks, the seroconversion rates were similar between the 2 groups.ConclusionIn patients with advanced CKD, the accelerated HBV vaccination regimen demonstrated a significantly higher seroconversion rate at 12 weeks of vaccination. This finding suggests that the accelerated regimen is an effective option to achieve rapid seroconversion before initiating hemodialysis or before undergoing kidney transplantation.

News (Medical) associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

03 Dec 2024

·endpts.com

GSK terminates Phase 2 trial of HBV therapeutic vaccine

GSK has axed a Phase 2 study of a chronic hepatitis B therapeutic vaccine, adding to a string of treatment R&D hurdles for the liver infection. The termination of GSK3528869 was the result of a failure on a predefined efficacy endpoint that was examined after the main phase of the trial, or 24 weeks after the last vaccination, according to an update last week to the federal trials database. The move affects only a portion of GSK’s HBV portfolio, as the UK pharma’s pipeline includes multiple other Phase 3 and mid-stage experimental candidates. GSK also makes the hepatitis B vaccine known as Engerix-B. But it marks the latest setback in the field. Roche culled four hepatitis B programs last quarter, Johnson & Johnson scrapped work in the space last year, and Antios Therapeutics shut down last year. Other companies are chugging along, like Vir Biotechnology, Precision Biosciences and Arbutus Biopharma. Arbutus, meanwhile, also faces its own dilemma. On Tuesday, the biotech’s third-largest shareholder publicly called for it to find a partner for its HBV portfolio. GSK hoped GSK3528869 would deliver a “functional cure by controlling and resolving the clinical sequelae of the infection and reducing the need for further treatment,” according to its pipeline page. There are treatments and vaccines for hepatitis B, but a cure has been difficult to achieve since the virus conceals itself in certain pockets of liver cells and continues to generate more copies. “It’s one of those areas of science that’s moving so fast, and we’re learning something new every day. You have to be in a situation where you can be very agile and pivot to keep up with the data,” Melanie Paff, a GSK medicine development leader, told Endpoints News at the time of snagging Johnson & Johnson’s license to an Arrowhead HBV drug last year. A GSK spokesperson didn’t return comment as of press time.

Phase 2Vaccine

05 Jul 2023

·www.prnewswire.com

Brii Biosciences Broadens its Leadership in Hepatitis B with a Portfolio Now Addressing Disease's Burdens from Prevention to Cure

Extension of BRII-179 license from VBI Vaccines to global rights bolsters Brii Bio's position to achieve best-in-class HBV functional cure in broad patient populations Company also acquires exclusive rights to PreHevbri®, a clinically differentiated, 3-antigen prophylactic vaccine, from VBI in Greater China and Asia Pacific markets Company to host conference call on July 6 at 8:30 AM (HKT) / July 5 at 8:30 PM (EST) BEIJING and DURHAM, N.C., July 5, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that it has entered into license agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), expanding the companies' collaboration in the hepatitis B virus (HBV) field. The newly formed license agreements with VBI signify a substantial expansion in the fight against HBV infection. In the first agreement, Brii Bio's exclusive license for BRII-179 (VBI-2601) is extended to worldwide markets, further establishing its leadership position in pursuing HBV functional cure. A growing body of evidence supports the importance of a strong HBV-specific immune response to achieve a durable HBV functional cure, highlighting a potentially important role for BRII-179 as part of a combination cure strategy. Additionally, Brii Bio will acquire exclusive rights to develop and commercialize PreHevbri® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. Under the terms of the agreements, VBI will receive upfront payments of $15 million including $5 million ring-fenced for manufacturing and supply as well as $3 million equity investment by Brii Bio, contingent on achievement of near-term milestones. VBI is also eligible to receive additional payments based on achievement of regulatory and commercial milestones, as well as royalties. The transaction is subject to certain closing conditions including the satisfactory completion of VBI's financing. "We are excited to substantially strengthen our partnership with VBI, expanding our HBV pipeline and reinforcing our commitment to public health by combatting HBV," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "By exploring the combination cure strategies across our portfolio, we aim to produce the most durable curative treatment in the broadest populations of HBV patients. The addition of PreHevbri®, VBI's prophylactic vaccine, to our HBV portfolio allows us to address HBV burdens from prevention to cure and jump-start our commercialization efforts in China and Asia Pacific with high HBV prevalence and population density, unlocking significant revenue potential." BRII-179 (VBI-2601) is currently undergoing Phase 2 studies led by Brii Bio in China, evaluating its potential as a key component of a functional cure for chronic HBV patients. Promising results from multiple studies, including Vir Biotechnology's MARCH study and Brii Bio's ongoing Phase 2 trials combining BRII-179 (VBI-2601) with BRII-835 (VIR-2218), have shown a strong correlation between durable HBsAg seroclearance and antibody seroconversion, highlighting the potential of BRII-179 (VBI-2601) as a valuable immunomodulatory component within a functional cure regimen. Brii Bio intends to further evaluate BRII-179 as part of a combination cure strategy in upcoming studies, with a goal to substantially improve upon cure rates achieved with PEG-IFN-α alone and to expand the population of chronic HBV patients eligible for a potential cure. PreHevbri®, also known as PreHevbrio® in the U.S. and Canada, PreHevbri® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac® in Israel, is the only approved 3-antigen HBV vaccine. In pivotal Phase 3 clinical studies, PROTECT and CONSTANT, PreHevbri® showed higher rates of and long-lasting seroprotection across all subjects aged 18+, and 5 to 8 times higher antibody titers compared to Engerix-B, a single-antigen HBV vaccine. Moreover, an integrated safety analysis of both studies demonstrated that PreHevbri® is well tolerated with no unexpected reactogenicity observed. Conference Call Information A live conference call will be hosted on Thursday, July 6 at 8:30 AM Hong Kong time (Wednesday, July 5 at 8:30 PM U.S. Eastern Time). All participants are required to register in advance of the call. For the registration link, please click here. About BRII-179 (VBI-2601) BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced B-cell and T-cell immunity. BRII-179 (VBI-2601) is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 (VIR-2218) and PEG-IFN-α as part of a potential functional cure regimen for the treatment of chronic HBV infection. About PreHevbri® PreHevbri® is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel). About Hepatitis B Hepatitis B viral infection (HBV) is one of the world's most significant infectious disease threats with more than 290 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in China, where 87 million people are infected.2 About Brii Bio Brii Biosciences ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address some of the world's most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and first-of-its-kind treatment options for postpartum depression (PPD) and major depressive disorder (MDD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . SOURCE Brii Biosciences Limited

Phase 2VaccineLicense out/inClinical ResultPhase 3

05 Jul 2023

·www.prnewswire.com

Brii Biosciences Provides Latest Clinical Development and Corporate Updates

Company extends BRII-179 license to global rights and introduces preventive vaccine, PreHevbri® in Greater China and Asia Pacific markets New data from BRII-835 + PEG-IFN-α study have demonstrated that robust anti-HBs antibody responses at the end of treatment are associated with sustained HBsAg loss 24 weeks post treatment Company owns exclusive global rights of BRII-693 in development for difficult-to-treat carbapenem-resistant Gram-negative bacterial infections Dr. David Margolis appointed as Chief Medical Officer to lead organization's late-stage clinical programs towards commercialization DURHAM, N.C. and BEIJING, July 5, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today provided updates on its diverse pipeline of infectious disease (ID) and central nervous system (CNS) disease candidates and announced a pivotal leadership transition that will further advance its strategic priorities. "We are proud to announce our latest achievements in advancing our mission to improve patient health and address critical public health issues. With expanded collaborations and acquisitions, including the worldwide license extension of BRII-179, the introduction of PreHevbri® vaccine in Greater China and Asia Pacific markets, and the acquisition of global rights for BRII-693, we are making remarkable progress in our infectious disease portfolio," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Additionally, it is with great pleasure that I introduce Dr. David Margolis as our new Chief Medical Officer. With his extensive experience and expertise both as a licensed ID specialist and a drug developer, Dr. Margolis will play a pivotal role in leading the successful execution of our late-stage clinical programs towards commercialization. Together, these strategic moves align seamlessly with our growth plans and represent important progress for our broader global strategy." Core Clinical Development Updates Hepatitis B Virus (HBV) Led by Brii Bio's team in China and partners, Vir Biotechnology, Inc. ("Vir,"NASDAQ: VIR) and VBI Vaccines, Inc. ("VBI,"NASDAQ: VBIV), the Company is addressing the full range of disease impact for HBV by progressing multiple combination studies to achieve a best-in-class functional cure in broad patient populations, as well as to commercialize a prevention vaccine in Greater China and Asia Pacific region. China and many Asia Pacific countries have the highest prevalence of HBV globally, with over 150 million people impacted by this disease (China ~86 million, Southeast Asia ~69 million HBsAg positive population1). Currently, there is no effective HBV functional cure available, highlighting the urgent need for a better prophylactic vaccine. In July 2023, Brii Bio announced substantial expansion of its HBV portfolio in collaboration with VBI. Under the terms of the agreements, Brii Bio extends its exclusive license to worldwide markets for BRII-179 (VBI-2601). Additionally, Brii Bio also acquires exclusive rights to develop and commercialize PreHevbri® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. In June 2023, Vir and VBI presented multiple clinical study results at the European Association for the Study of the Liver (EASL) Congress™ 2023: In follow-up data from Vir's Phase 2 trial of combination 24 or 48 weeks of VIR-2218 (BRII-835) on top of a course of up to 48 weeks of pegylated interferon alpha (PEG-IFN-α), 16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment. Anti-HBs titers greater than 500 mIU/mL at the end of treatment were associated with sustained HBsAg loss at 24 weeks after the end of treatment. Data from Part A of Vir's Phase 2 MARCH trial evaluating short treatment duration of combinations of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) in chronic HBV participants demonstrated a 2.7-3.1 log10 IU/mL decline in HBsAg levels and 90% of participants achieved HBsAg reduction below 10 IU/mL at the end of treatment. VBI presented follow-up data in a subset of participants from the pivotal Phase 3 study, PROTECT, up to 3.5 years after completion of immunization with PreHevbrio® (also known as PreHevbri® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac® in Israel), a prophylactic 3-antigen HBV vaccine. The mean anti-HBs titers in participants vaccinated with PreHevbrio® were more than 5x higher than those vaccinated with Engerix-B (1287 vs. 254 mIU/mL) suggesting that T-cell responses of PreHevbrio® may contribute to long lasting and strong humoral immune responses and greater durability compared with Engerix-B. In May 2023, Brii Bio submitted an IND application to the NMPA of China for the development of BRII-877 (VIR-3434), and a Phase 1 clinical study is expected to start by the end of 2023. In the second half of 2023, the Company expects data readouts from two Phase 2 trials: Additional data from the Phase 2 study evaluating BRII-835 (VIR-2218) and BRII-179 (VBI-2601) combination. Topline results from the Phase 2 study evaluating BRII-179 (VBI-2601) in combination with PEG-IFN-α. Brii Bio plans for additional combination studies with the earliest to start in 2H 2023. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorders Brii Bio is developing its internally-discovered BRII-296 therapeutic candidate as a first-of-its-kind one-time injection treatment with the potential to expand the PPD and MDD treatment landscapes for patients in the U.S. In June 2023, Brii Bio announced the dosing of the first subject in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study, currently underway, aims to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy volunteers. Brii Bio is working closely with the U.S. Food and Drug Administration (FDA) to align and agree on a PPD treatment protocol in preparation for its Phase 2 proof-of-concept (POC) study to be initiated in the second half of 2023. Brii Bio is actively working to expand the clinical indications for BRII-296 and plans to initiate additional studies in the U.S. in 2024. Additional Pre-Clinical and Clinical Development Updates Human Immunodeficiency Virus (HIV) Infection In December 2022, Brii Bio successfully lifted the U.S. FDA clinical hold, enabling the conduct of the Company's planned Phase 1 study to investigate a lower oral dose of once-weekly BRII-732, with dosing initiated in 2Q 2023. The Company is exploring partnership opportunities to continue developing BRII-732 as part of a potential oral, once-weekly, long-acting combination treatment option for HIV patients. The Company is pursuing partnership opportunities for BRII-753 as part of a long-acting, subcutaneous injection with potential for dosing once monthly, once quarterly, or twice-yearly combination treatment option for HIV patients. MDR/XDR Gram-Negative Bacteria Infections In June 2023, Brii Bio announced definitive agreements with Qpex Biopharma ("Qpex") to acquire exclusive global rights of BRII-693 (QPX-9003), expanding its existing rights in Greater China. The Company returns its exclusive rights of BRII-636 (QPX-7728 or OMNIvance) and BRII-672 (QPX-7831 or ORAvance) in Greater China to Qpex in connection with the acquisition of Qpex by Shionogi. In April 2023, Brii Bio submitted a pre-IND to the NMPA of China for the development of BRII-693 in China. BRII-693 has a highly differentiated safety and efficacy profile to address the most difficult-to-treat Acinetobacter baumannii and Pseudomonas aeruginosa infections resistant to carbapenem. Nontuberculosis Mycobacteria (NTM) Lung Disease Brii Bio's partner, AN2 Therapeutics, Inc. ("AN2,"NASDAQ: ANTX) is enrolling its Phase 2/3 pivotal trial evaluating once-daily, oral epetraborole (BRII-658) for treatment-refractory MAC lung disease. AN2 reported in May that there were nearly 80 sites active in its pivotal Phase 2/3 trial of epetraborole in treatment-refractory MAC lung disease. Corporate Update Dr. David Margolis has been appointed Chief Medical Officer (CMO) after serving as Brii Bio's Head of Infectious Diseases Therapy Area for nearly three years. As the CMO, Dr. Margolis will play a critical role in the Company's late-stage clinical development towards commercial growth across the pipeline. In addition, he will continue to fulfill existing responsibilities that he previously held as Head of Infectious Diseases Therapy Area. Meanwhile, Dr. Li Yan will leave the company to pursue other interests. Brii Bio expresses sincere gratitude to Dr. Yan for his contributions to the Company in the past 5 years. About Brii Bio Brii Biosciences is a biotechnology company developing therapies to address some of the world's most common diseases where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs to develop a novel functional cure for hepatitis B viral infection (HBV) and first-of-its-kind treatment options for postpartum depression (PPD) and major depressive disorder (MDD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . 1 Lancet Gastroenterol Hepatol. 2018; 3(6): 383-403 SOURCE Brii Biosciences Limited

Phase 2Clinical ResultPhase 1License out/inPhase 3

100 Deals associated with Hepatitis B vaccine(GlaxoSmithKline Plc)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	DBSALT001978

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hepatitis B	US	GlaxoSmithKline LLC	28 Aug 1989

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Preclinical	MY	GSK Plc	01 Dec 1999
Hepatitis B	Preclinical	ES	GSK Plc	01 Dec 1999
Hepatitis B	Preclinical	CZ	GSK Plc	01 Dec 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04398706 (CTgov)	Phase 2	Diphtheria \| Hepatitis B \| Pneumonia \| Rubella \| Mumps \| Measles \| Whooping Cough \| Tetanus \| Poliomyelitis \| Chickenpox \| Influenza, Human	852	Pentacel+SP0202-IIb+Prevnar 13 (Stage I: Group 1 SP0202-IIb)	kpkaixjlij(yqntrokvzz) = jyyjibwrzv yeakgddsss (etwkgiwbic, ouxocymvku - bedrtfbjhg) View more	-	12 Nov 2024
				Pentacel+SP0202-VI+Prevnar 13 (Stage I: Group 2 SP0202-VI)	kpkaixjlij(yqntrokvzz) = eqpaisdpwl yeakgddsss (etwkgiwbic, oozhqbroeq - bycwymfbvj) View more
NCT03630705 (MET33, CTgov)	Phase 3	Meningococcal Infections	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	tqiyxmpbxc(iqzeoihuhx) = sxxxvsyeek vhkuiqmhlk (vkiorskrax, bgnusqzgqb - pbmhgtqbdf) View more	-	19 Oct 2023
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine,+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	xykdwwhdfg(epakvraoli) = rnceluarak osnpxvczjo (ptbmoaokno, oozkxtsrry - myewrfisgg) View more
NCT04531098 (CTgov)	Phase 3	Hepatitis B	402	Engerix-B	qazcfguncc(evmhvauqwx) = euojshypaz hbvtztypdk (bqgkeeizwe, mjejrwatgt - ppzeifecxj) View more	-	24 Jun 2022
NCT02169674 (CTgov)	Phase 4	Hepatitis B	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	irvalszzhu(ohnqpzyltp) = dmqcmdfedh kqfaaabqcm (lrmvsxvoqr, qdnrtdgpls - bzwbaocfne) View more	-	21 Mar 2019
				EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	irvalszzhu(ohnqpzyltp) = cyeitjcepl kqfaaabqcm (lrmvsxvoqr, pzrvbeyghs - ebuftaltzx) View more
NCT01777295 (CTgov)	Phase 2	Hepatitis B	81	Placebo (HBsAg/AS_1 Group)	(ytgnxtokfn) = dlnkmlbghg kmgndqxmkt (gvhtlmvxbe, gdsjscsbnx - smfgmbjxdv) View more	-	04 Jan 2019
				Engerix-B_1 (Engerix-B_1 Group)	(ytgnxtokfn) = rdwqffogyd kmgndqxmkt (gvhtlmvxbe, tntnnezsmz - zfokthuqch) View more
ASN2018	Phase 3	anti-HBs levels	-	Heplisav-B	ldonvnhhda(cidoslnahe) = pxkopwppsz ntdzonaqst (chzvwszsji )	Positive	23 Oct 2018
				Heplisav-BEngerix-BB (Engerix-B)	ldonvnhhda(cidoslnahe) = phupxxwpql ntdzonaqst (chzvwszsji )
NCT02901951 (CTgov)	Phase 4	Hepatitis B	106	Engerix-B	galwrvqqes(sgmtatatzz) = hdnxrysmfd ojmwcfihkt (uxalxskcrs, lyghqbkwzz - dxkbystgww) View more	-	03 Aug 2018
NCT01817725 (CTgov)	Phase 1	Hepatitis B, Chronic	20	HBV vaccine (Engerix B)	qyzpxtwpar(eytajdwpyz) = dyouwmpbpi jnyedttygw (ivtnyqqksi, rbnpufukwu - vmotaiqjnd) View more	-	02 May 2017
NCT01847430 (CTgov)	Phase 4	Hepatitis B	303	Engerix™-B Kinder	exxfifjrje(cusgdhdfxk) = gvjokkourb qduwukmxbq (lgrpsyotor, wrofurixqo - phvfnrgpuz) View more	-	02 Mar 2016
NCT00534638 (CTgov)	Phase 4	Human Papillomavirus Infection	34,412	Engerix-B+Cervarix (Cervarix/Engerix-B A Group)	yiyhsxrclu(xrfgtnzyle) = agzkbuqxyj qtjkzwryfx (cglmfkcjcs, xezztsjlps - llmysgeqhu) View more	-	26 Jan 2016
				Engerix-B+Cervarix (Cervarix/Engerix-B B Group)	yiyhsxrclu(xrfgtnzyle) = weerxqvhxr qtjkzwryfx (cglmfkcjcs, grvwgvlhze - vlpaxyuyqm) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Hepatitis B vaccine(GlaxoSmithKline Plc)

Overview

Basic Info

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation