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.

开始日期2021-06-08

申办/合作机构

Academic Medical Center University of Amsterdam

NCT04193189

/ Completed临床3期IIT

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.

开始日期2020-12-14

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT04398706

/ Completed临床2期

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])

开始日期2020-05-22

申办/合作机构

Sanofi Pasteur

100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的临床结果

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100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的转化医学

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100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的专利（医药）

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项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的文献（医药）

2024-07-19·Cureus

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

Article

作者: 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.

2024-07-01·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

作者: 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.

2024-04-01·Kidney International Reports

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

Article

作者: 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.

项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的新闻（医药）

2024-12-03

·EndPoints

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.

临床2期疫苗

2024-11-28

·药渡

一家疫苗企业，破产！

2024年11月，美国VBI Vaccines公司宣布：公司破产终止运营。 VBI Vaccines公司总部位于美国马萨诸塞州剑桥市，公司拥有专有包膜VLP（“eVLP”）平台技术，用于开发模仿病毒自然表现的候选疫苗，以靶向和克服重大传染病，包括乙型肝炎、冠状病毒和巨细胞病毒（CMV）以及包括胶质母细胞瘤（GBM）在内的侵袭性癌症。 2021年12月1日，VBI Vaccines公司宣布，美国FDA已批准第三代乙肝病毒（HBV）疫苗PreHevbri（Sci-B-Vac）上市，用于在18岁及以上成年人中预防所有已知HBV亚型引起的感染。新闻稿指出，这是FDA批准的首款靶向三种乙肝病毒抗原的成人HBV疫苗。在关键性3期临床研究PROTECT和CONSTANT中，与GSK的单抗原HBV疫苗Engerix-B相比，PreHevbri在所有18岁以上的受试者中均显示出较高且持久的血清保护率，且抗体滴度高达5至10倍。此外，两项研究的综合安全性分析均表明，PreHevbri耐受性良好，未观察到非预期的反应原性。但是这款疫苗在上市之后，商业化进程却非常不理想。 2022年，在这款疫苗上市后的第一个完整的商业化年度，VBI Vaccines公司的营业收入仅仅达到可怜的108.2万美元。 2023年，VBI Vaccines公司的营业收入为868.2万美元，但是销售费用达到惊人的4214万美元，公司全年亏损9283万美元。从商业化角度来看，这款上市疫苗产品无疑是公司的一场灾难。 VBI Vaccines公司宣布，由于破产和业务终止，公司正在全国范围内自愿召回所有剩余的乙型肝炎疫苗PreHevbri(Sci-B-Vac) 。 VBI Vaccines公司的破产，牵动了千里之外的一家中国药企。 2023年7月6日，港股18A板块上市的药企腾盛博药宣布，与VBI Vaccines签订许可协议，以拓展双方在乙型肝炎（HBV）领域的战略合作。腾盛博药将从VBI扩展BRII-179许可至全球权益，并且获得具有临床差异化的3抗原预防性疫苗PreHevbri在大中华区及亚太市场的独家权益。根据协议条款，VBI将获得1500万美元的首付款，其中包括用于制造和供应的500万美元，以及腾盛博药的300万美元股权投资，具体取决于近期里程碑的实现情况。除此之外，VBI还有资格获得基于实现注册和商业化里程碑的额外付款，以及特许权使用费。完成以上交易需满足若干交割条件，包括VBI顺利完成融资。应该说，引进PreHevbri这款疫苗到中国市场，具有一定的积极意义。作为VBI的第三代乙肝疫苗，PreHevbri含有S，Pre-S1和Pre-S2三种乙肝表面抗原，在乙肝母婴阻断、无应答人群再免疫，甚至乙肝治疗等方面均有不俗的表现。目前国内的CHO表达的乙肝疫苗只含有乙肝表面抗原（HBsAg），并没有Pre-S1和Pre-S2两种抗原蛋白。所以PreHevbri确实具备了一定的差异性。目前，随着VBI Vaccines公司的破产，与其有密切合作关系的腾盛博药，将如何善后处理二者之间的合作协议，目前尚未有确切消息。药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇

疫苗引进/卖出临床3期财报

2024-11-22

·健识局

美国乙肝疫苗公司破产，绊倒中国创新药企

11月15日，VBI Vaccines宣布：公司破产终止运营，将在全美范围内召回乙肝疫苗PreHevbrio。 VBI是一家纳斯达克上市公司，PreHevbrio是其开发的一款第三代预防性成人乙肝疫苗，2021年11月登陆美国市场，是VBI 唯一一款上市产品。今年7月VBI 申请破产，意味着PreHevbrio也将成为无本之木。原本只是一则大洋彼岸的消息，却意外牵连到一家国内创新药公司。去年7月，港股上市公司腾盛博药引进PreHevbrio在大中华区及澳大利亚、新加坡等亚太国家的独家开发和商业化权益，同时，将此前引进的一款乙肝治疗性疫苗BRII-179的权益扩大到全球市场，为此还付给VBI公司700万美元首付款。从一家濒临破产的公司引进产品，这在国内医药史上还不多见。腾盛博药在VBI宣布破产后，双方合作还会如何开展？ 11月19日，腾盛博药回应健识局称：撤回是因对方公司破产和运营终止，而非产品问题。不过，腾盛博药不会进一步开发PreHevbrio。若未来有其他公司接手该项目，将重新评估是否继续推进该产品。对于BRII-179，公司正独立开展研发，预计VBI的破产不会对BRII-179的临床开发产生影响。双方捆绑颇深 PreHevbrio是美国市场上获批的唯一一款靶向3种乙肝病毒抗原的预防性成人乙肝疫苗，已经在美国、英国、加拿大、欧盟等地区上市。尽管产品具有一定突破性，但奈何竞争对手过于强大。PreHevbrio的竞争对手是默沙东、GSK开发的Recombivax-HB、Engerix-B这两款成功使用了近四十年的重组疫苗、以及2001年上市的GSK开发的世界上唯一一种甲肝、乙肝混合肝炎疫苗Twinrix。 PreHevbrio的销售成绩可以用惨烈来形容。2022年进入市场后，当年销售额110万美元；第二年销售额不过310万美元。直到退市，VBI都没能触动“疫苗四巨头”控制的市场。 VBI公司另一款在研产品治疗性乙肝疫苗BRII-179，倒是可能有市场价值。但因为公司破产，研发停止，所有预期都成了泡影。腾盛博药为何会看上这样一家公司？腾盛博药也是一家专注于乙肝领域创新疗法的研发公司，2018年由前GSK高级副总裁、感染性疾病治疗领域部门负责人洪志博士创立，2021年凭借首个国产新冠中和抗体安巴韦单抗/罗米司韦单抗出过风头。腾盛博药可能并不是特别看重乙肝疫苗PreHevbrio。此次最新的对外口径中，腾盛博药明确不再自主开发PreHevbrio。治疗性乙肝疫苗BRII-179吸引力会更大一些。2018年12月，腾盛博药从VBI引进BRII-179，获得了其在大中华区的商业化权益。此后，BRII-179与腾盛博药从Vir引进的siRNA药物BRII-835一道，成为腾盛博药在乙肝领域的两款核心管线。腾盛博药与VBI的捆绑比较紧密，除了合作推进BRII-179单药在许可区域的临床外，2021年12月，腾盛博药还与VBI签订补充协议，开展额外的联合用药临床试验。同时，腾盛博药还认购了VBI部分股份。2023年7月，腾盛博药进一步获得BRII-179的全球权益。到今年2月，腾盛博药可能预见到合作公司情势不妙，为了消除后患，进一步包揽了BRII-179的所有权益，包括知识产权、以及VBI在以色列的生产设施，同时附加了一款癌症疫苗VBI-1901在亚太地区（除日本外）的市场权益，交易总金额最高3300万美元。当时外媒报道称，这笔交易为VBI减少了70%的债务负担，但VBI的破产已无可挽回。今年7月，知悉VBI的破产，腾盛博药发布公告：公司自2024年2月起就一直与VBI密切合作，致力于将BRII-179的生产能力平稳转移至第三方合同开发和生产商。目前该技术转移正在进行中，预计VBI的破产不会对BRII-179的临床开发产生影响。近期，腾盛博药进一步回应健识局称，目前BRII-179所有中国及海外的临床试验均由腾盛博药独立开展进行，无需VBI任何参与。同时，公司也为BRII-179的临床研究确保了稳定的临床供应。艰难乙肝治愈路腾盛博药一路加持VBI公司，可能是因为两家公司有颇多相似之处。双方都在成立初期大手笔投入新冠疫苗、药物的研发：VBI曾将三种候选新冠疫苗管线推进到临床研究，尽管因各种原因都未能上市。腾盛博药为“首个国产新冠中和抗体”投入2亿美元。此外，腾盛博药与VBI一样，都将实现乙肝功能性治愈作为公司使命。乙肝市场颇为庞大，仅在中国，就有8700万感染者，目前，乙肝还没有有效的治愈办法，长效干扰素的临床治愈率仅有3%-8%，且副作用很大，很多患者无法耐受。治愈乙肝看似目标不大，其实是全球大牌药企都没能达到的终点。去年，VBI裁员30%-35%，并削减管线，表示要专注于推进BRII-179，最终落得破产的地步。腾盛博药现在还没有近忧，根据年报，公司目前手握20多亿元现金，足以支撑运营到2027年。不过，腾盛博药在资本市场的表现并不乐观。去年2月初，马云、云峰基金、美国投资公司等一系列股东纷纷减持，引发公司股价下跌。今年2月15日，腾盛博药宣布，BRII-835与BRII-179联合疗法用于治愈乙型肝炎病毒（HBV）感染II期研究取得了积极的中期结果，但未能获得市场认可，股价继续暴跌。目前，公司股价不过1.04港元，与52.6港元的历史高点相距甚远。目前，腾盛博药还在和合作伙伴Vir开展各种联合治疗方案的临床研究，除了BRII-835和BRII-179外，还有BRII-179+长效干扰素、BRII-835+长效干扰素等等，但就已经公布的前期结果来看，没有一个接近大规模治愈。这些II期临床还在继续推进，腾盛博药告诉健识局，期待在明年获得更多的研究数据，为未来3期临床试验提供策略依据。撰稿丨李傲编辑丨江芸贾亭运营｜山谷插图｜视觉中国声明：健识局原创内容，未经许可请勿转载 “减肥神药”线上预约新模式，医药电商竞争迎来新变局感冒拍个CT就要花六百？影像检查即将降价新事 | 有媒体称默沙东中国糖尿病业务部门裁员

引进/卖出疫苗siRNA

100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	DBSALT001978

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乙型肝炎	美国	GlaxoSmithKline LLC	1989-08-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
乙型肝炎	临床前	马来西亚	GSK Plc	1999-12-01
乙型肝炎	临床前	西班牙	GSK Plc	1999-12-01
乙型肝炎	临床前	捷克	GSK Plc	1999-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04398706 (CTgov)	临床2期	白喉 \| 乙型肝炎 \| 肺炎 \| 风疹 \| 腮腺炎 \| 麻疹 \| 百日咳 \| 破伤风 \| 脊髓灰质炎 \| 水痘 \| 流感病毒感染	852	Pentacel+SP0202-IIb+Prevnar 13 (Stage I: Group 1 SP0202-IIb)	構衊簾鹹壓願鬱襯願顧(淵襯顧築願壓鏇鬱糧襯) = 鏇壓糧夢餘築餘醖襯窪窪膚願築窪製艱遞餘構 (積廠範淵鹽觸襯壓淵製, 願糧範選範觸簾糧餘鹽 ~ 艱觸鑰鹹齋壓窪積遞淵) 更多	-	2024-11-12
				Pentacel+SP0202-VI+Prevnar 13 (Stage I: Group 2 SP0202-VI)	構衊簾鹹壓願鬱襯願顧(淵襯顧築願壓鏇鬱糧襯) = 構遞鏇壓廠壓餘製鹹範窪膚願築窪製艱遞餘構 (積廠範淵鹽觸襯壓淵製, 積糧醖鹹選遞糧鏇築膚 ~ 蓋製顧鑰憲鬱餘鹹夢顧) 更多
NCT03630705 (MET33, CTgov)	临床3期	脑膜炎球菌感染	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))	鹽構鬱構壓鹽淵選廠窪(壓夢窪淵膚糧壓鏇願壓) = 蓋繭蓋齋遞觸鏇鑰蓋網願醖餘憲遞網憲餘鹹蓋 (衊餘築壓構範網獵築遞, 鹽選鹹網構遞膚鏇獵憲 ~ 願鏇淵製範鏇糧築艱顧) 更多	-	2023-10-19
				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))	窪構積淵顧齋製範醖顧(範鹹鑰顧鑰獵鏇齋觸憲) = 壓淵衊顧築淵憲鏇窪夢膚願積廠鑰餘夢壓壓選 (餘鹹壓鏇鑰壓襯襯積顧, 淵醖構鑰膚齋夢窪築膚 ~ 蓋築鑰築襯獵選顧鑰夢) 更多
NCT04531098 (CTgov)	临床3期	乙型肝炎	402	Engerix-B	夢餘積鏇艱遞鬱餘簾範(醖窪鹹簾鹽網鬱壓艱艱) = 顧願醖糧選網糧選製壓網餘憲築選淵壓餘構製 (構鬱鹹襯遞廠淵醖壓夢, 糧艱構鑰醖蓋遞積襯選 ~ 淵衊憲積繭遞夢蓋淵願) 更多	-	2022-06-24
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	廠積廠鹽願構憲廠憲鑰(齋選鹹構艱襯醖遞鏇製) = 繭窪鹹襯繭窪簾構廠艱範構簾簾構衊鑰範蓋顧 (積艱簾憲憲夢簾觸齋鏇, 鹽壓夢製憲繭構簾廠簾 ~ 夢壓夢觸構淵簾築艱艱) 更多	-	2019-03-21
				EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	廠積廠鹽願構憲廠憲鑰(齋選鹹構艱襯醖遞鏇製) = 鏇觸選構構鏇積衊遞膚範構簾簾構衊鑰範蓋顧 (積艱簾憲憲夢簾觸齋鏇, 獵憲簾糧鹽遞廠顧膚鬱 ~ 鑰遞醖顧糧鹽製蓋襯鬱) 更多
NCT01777295 (CTgov)	临床2期	乙型肝炎	81	Placebo (HBsAg/AS_1 Group)	(淵網廠顧醖齋窪獵襯蓋) = 鬱膚夢齋積鏇窪膚夢憲淵觸簾窪顧製襯壓簾構 (範夢鏇範鏇鑰鬱夢製鹹, 糧獵襯齋製範憲窪築蓋 ~ 遞簾糧獵觸憲範膚簾餘) 更多	-	2019-01-04
				Engerix-B_1 (Engerix-B_1 Group)	(淵網廠顧醖齋窪獵襯蓋) = 夢願願憲餘網膚艱鑰夢淵觸簾窪顧製襯壓簾構 (範夢鏇範鏇鑰鬱夢製鹹, 鬱窪憲蓋蓋鏇繭積艱廠 ~ 齋夢築窪齋鹹膚築繭壓) 更多
ASN2018	临床3期	anti-HBs levels	-	Heplisav-B	獵範選製製遞餘窪憲築(繭鬱遞衊積積廠夢鹹壓) = 鹽淵艱鹽艱膚遞鬱鹹選衊齋鑰淵膚艱窪憲憲醖 (壓醖衊蓋醖壓築範憲夢 )	积极	2018-10-23
				Heplisav-BEngerix-BB (Engerix-B)	獵範選製製遞餘窪憲築(繭鬱遞衊積積廠夢鹹壓) = 淵鏇壓顧鑰製範糧夢繭衊齋鑰淵膚艱窪憲憲醖 (壓醖衊蓋醖壓築範憲夢 )
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	遞醖鬱網構壓窪糧醖觸(鑰願鑰鏇壓憲鏇蓋鹽簾) = 鹹糧觸網積糧鏇獵醖憲醖獵鹽鹹夢遞築廠餘鏇 (餘繭壓膚襯鹹鑰鹹選構, 願願鏇齋鬱鬱製觸齋繭 ~ 壓範蓋遞壓鹽願網簾鏇) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine (Engerix B)	製壓糧鏇顧遞鬱夢夢壓(餘網網膚鏇淵顧膚膚獵) = 鹹鹽襯鬱鹽艱獵鏇製遞窪鹹憲鹽襯築繭選窪願 (廠鏇網簾鏇鑰糧築餘鑰, 襯膚襯鏇選艱鬱網廠襯 ~ 鏇窪繭艱積觸範襯簾願) 更多	-	2017-05-02
NCT01847430 (CTgov)	临床4期	乙型肝炎	303	Engerix™-B Kinder	築構艱淵簾窪鑰簾夢廠(齋夢艱積衊窪鹹壓積積) = 夢選遞憲鹽遞餘窪積襯遞範餘夢鑰憲築憲糧遞 (蓋製鹹齋膚憲獵齋襯膚, 夢憲遞廠憲糧糧蓋衊繭 ~ 齋淵積淵繭鹽顧淵餘膚) 更多	-	2016-03-02
NCT00534638 (CTgov)	临床4期	乳头状瘤病毒感染	34,412	Engerix-B+Cervarix (Cervarix/Engerix-B A Group)	繭簾簾築齋遞築艱鹹網(齋淵夢憲餘蓋鹹製鏇鏇) = 網網構廠製繭齋蓋餘簾餘鬱醖衊獵艱壓夢襯範 (廠壓膚構鹹顧壓壓鹽襯, 淵鑰鹹鏇獵繭繭襯製艱 ~ 範獵憲醖鏇構醖夢網窪) 更多	-	2016-01-26
				Engerix-B+Cervarix (Cervarix/Engerix-B B Group)	繭簾簾築齋遞築艱鹹網(齋淵夢憲餘蓋鹹製鏇鏇) = 顧鹹糧膚蓋窪構鏇選築餘鬱醖衊獵艱壓夢襯範 (廠壓膚構鹹顧壓壓鹽襯, 夢構鏇蓋觸廠壓壓糧獵 ~ 憲艱醖選鬱餘繭繭衊製) 更多