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

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 SA

NCT04072211

/ Completed临床4期IIT

Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District

Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. Infection with HBV can be self-limiting depending on age and immunity status of the infected person. Acute infection with HBV is cleared within six months of initial infection while chronic infection can last longer than six months. HBV can be transmitted perinatally, sexually, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood. Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCWs). In this population, HBV infection can occur through occupational exposure. In fact, the hepatitis B virus is more contagious than human immunodeficiency virus (HIV) during a needle stick injury (30% versus 0.5%). It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission. Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.

开始日期2019-11-25

申办/合作机构

Centre For Infectious Disease Research

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2025-07-01·Annals of Hepatology

A global comparison of hepatitis B & C drug pricing

Article

作者: Yao, Leah ; Tsai, Catherine ; Congly, Stephen E ; Malik, Getan ; Jesudian, Arun B ; Brown, Robert S ; Ying, Xiaohan

INTRODUCTION AND OBJECTIVES:

Drug pricing is a major driver of healthcare spending in the United States (US) and the cost of medications in the US is up to three times higher than other countries. This cross-sectional study aims to investigate the current price differences between hepatitis B (HBV) and hepatitis C (HCV) antiviral therapies in the US as compared to peer high-income countries.

MATERIALS AND METHODS:

Publicly available drug formularies for Canada, UK, Japan, France, Germany, Italy, and Australia were used to collect 2024 prices for seven HBV medications (lamivudine, adefovir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate, entecavir, peginterferon alfa-2a, emtricitabine/TDF) and seven HCV medications (sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, sofosbuvir, ribavirin, elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir). US prices were obtained from UpToDate®'s listed representative average wholesale price and Medicare Part D 2022 drug prices.

RESULTS:

US prices for HBV originator medications were on average 4.71x (range 1.99-6.17x) the prices in the peer countries. US generic HBV drug prices for TDF, entecavir, and emtricitabine/TDF were on average 45% cheaper or 0.55x less than the average generic prices in peer countries (range 0.48-0.66x). US originator prices for HCV medications were on average 1.83x the prices in peer countries (range 0.63-2.66x).

CONCLUSIONS:

HBV and HCV originator medications cost significantly more in the US compared to seven other major industrial countries. However, the introduction of HBV generic medications has lowered the cost of treatment for patients in the US. Future adoption of international reference pricing may help bridge remaining pricing disparities.

2025-05-01·JHEP Reports

Auto-antibodies against interferons are common in people living with chronic hepatitis B virus infection and associate with PegIFNα non-response

Article

作者: Maini, Mala K ; Hill, Robert ; Payne, Olivia ; Mauri, Claudia ; Idilli, Orest ; Kennedy, Patrick T F ; Griffith, Sarah ; Etoori, David ; Bradford, Hannah F ; Fink, Douglas L ; Gill, Upkar S ; Kartikapallil, Nikita ; McCoy, Laura E

Background & Aims:

Type one (T1) and three interferons (T3IFNs) are implicated in chronic hepatitis B (CHB) immunopathogenesis. IFN remains the only licenced immune modulating therapy for CHB. We measured the prevalence of auto-antibodies (auto-Abs) against T1 and T3IFNs to examine the hypothesis that they impact HBV control and treatment response, as highlighted by COVID-19.

Methods:

Our multi-centre retrospective longitudinal study accessed two CHB cohorts; auto-Ab levels and neutralisation status were measured against T1IFN and T3IFN. Associations were tested against HBV clinical parameters.

Results:

Overall, 16.7% (46/276) of patients with CHB had any detectable anti-IFN auto-Abs at any time and 6.5% (18/276) anti-T3IFN auto-Abs, with a high incidence of PegIFNα-induced de novo auto-Abs (31.4%, 11/35). However, only a minority of auto-Ab-positive sera demonstrated neutralisation in vitro (4/46, 8.7%). Auto-Ab positivity correlated with higher median HBsAg levels (p = 0.0110). All individuals with detectable anti-T1IFN auto-Abs were PegIFNα non-responders.

Conclusions:

Non-neutralising anti-IFN auto-Abs are common in CHB and associate with higher median HBsAg levels. Further prospective study of anti-cytokine auto-Abs in CHB are required to characterise the association with long-term outcomes.

Impact and implications:

HBV and PegIFNα individually may induce broad autoreactivity associated with dysregulated antiviral immune responses. Auto-Ab screening prior to PegIFNα treatment or other immunotherapies may play a critical role in predicting treatment responses.

2025-01-01·ARTIFICIAL ORGANS

Liposome‐encapsulated hemoglobin rescues hemorrhagic shock heart through anti‐ischemic and anti‐arrhythmogenic effects on myocardium in repetitive 65% bleeding rat model

Article

作者: Kinoshita, Manabu ; Sakai, Hiromi ; Adachi, Takeshi ; Takase, Bonpei ; Higashimura, Yuko ; Masaki, Nobuyuki

Abstract:

Background:

Phase I clinical trial of an artificial oxygen carrier (liposome‐encapsulated hemoglobin vesicles [HbVs]) is safely completed, considering the other clinical application. Herein, we aimed to investigate the resuscitation effects of HbVs in cases of lethal hemorrhage, including the mechanisms involved.

Methods:

Optical mapping analysis (OMP) and electrophysiological studies (EPS), immunostaining pathological examination for hypoxia‐inducible factor‐1α (HIF1‐alpha) in the heart tissue, and blood troponin I (TnI) level measurements were performed in rats that underwent five rounds of spontaneous arterial bleeding with up to 65% hemorrhage.

Results:

Ten rats in each group were resuscitated by a transvenous infusion of 5% albumin (ALB), washed erythrocytes (wRBC), HbVs (HbV), 50% HbV diluted by 5% albumin (50% HbV), and 66% HbV diluted by 5% albumin (66% HbV). The rats in the ALB and 50% HbV groups died, whereas those in the other groups survived. OMP showed impaired action potential duration dispersion (APDd) in the left ventricle in the ALB and 50% HbV groups, which was attenuated in the other groups. Lethal arrhythmias were provoked by EPS in the ALB and 50% HbV groups but not in the other groups. HIF1‐alpha was positively stained only in the ALB and 50% HbV groups. TnI levels were elevated in the ALB and 50% HbV groups.

Conclusions:

Acute lethal hemorrhage causes myocardial ischemia with hypoxia and arrhythmias, which may be induced by impaired APDd and myocardial damage, reflected in the increased levels of HIF1‐alpha and TnI. HbVs could be useful for resuscitation and may help save patients with injuries such as gunshot wounds.

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

2025-05-22

·摩熵医药

带状疱疹疫苗 “战国时代”：GSK 霸主地位不保？六家本土药企强势突围！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。本文以摩熵咨询《中国带状疱疹疫苗行业分析报告》为依据，解读行业竞争格局。全球疫苗巨头葛兰素史克，以深厚研发与市场积累，左右行业发展；百克生物作为本土代表，凭创新与本土化优势抢占市场。绿竹生物、迈科康生物等企业，凭借技术、研发及市场策略各显神通，共同勾勒出行业未来发展图景。 01GSK：全球领先生物制药巨头，疫苗业务领跑行业葛兰素史克（GSK）成立于2000年，总部位于英国伦敦，作为全球领先的制药和医疗保健公司，业务广泛覆盖抗感染、中枢神经系统等领域，在150多个国家开展业务。它专注创新药物、疫苗与健康产品研发，是世卫组织认定唯一研发艾滋病、疟疾和结核病疫苗的公司。在疫苗业务方面，2024年营收占比达29.0%，依托12个生产基地，2022年具备生产交付5亿剂疫苗的能力，当年药物和疫苗交付量达23亿，全球每年40%的儿童接种其疫苗，超20种疫苗抵御脑膜炎等疾病。财务上，2024年营业额134亿英镑，同比增长8%，核心经营利润91亿英镑，同比增长13% ，核心每股收益159.3便士，同比增长12% ，经营活动现金流79亿英镑。在带状疱疹疫苗领域，2022-2024年销售额分别为29亿、35亿、34亿英镑，其上市疫苗还有Cervarix希瑞适双价人乳头瘤病毒吸附疫苗、Engerix B安在时重组乙型肝炎疫苗（酿酒酵母）等。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于GSK官网等公开资料葛兰素史克（GSK）秉持创新多元战略，聚焦核心领域，借国际化合作促增长。其研发管线丰富，众多产品处于关键阶段。疫苗领域，虽未直接提及带状疱疹疫苗，但呼吸道合胞病毒、脑膜炎、水痘等疫苗研发亮眼；药物研发覆盖多疾病领域，通过广泛研发为健康事业及产品创新筑牢根基。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、GSK官网等公开资料02百克生物：专注传染病防治，水痘疫苗市占率高，带状疱疹疫苗填补国内空白百克生物成立于2004年，作为专注传染病防治的创新药企，通过完善体系、多元技术平台，历经水痘疫苗等产品上市，2023年带状疱疹疫苗上市填补国内空白，凭借丰富产品矩阵在国内疫苗市场尤其是带状疱疹疫苗领域发挥重要防控作用。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于百克生物官网等公开资料截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、百克生物官网等公开资料03绿竹生物：创新疫苗与抗体领域的新锐力量绿竹生物自2001年创立，专注创新型人用疫苗及治疗性生物制剂研发，致力于疾病预防。截至2023年末，三款产品处于临床阶段，核心产品LZ901进入Ⅲ期临床并获美国FDA批准开展美国Ⅰ期临床，有望成国内首款创新重组带状疱疹疫苗，且具全球首创四聚体分子结构。资本运作上，2019-2023年多轮融资助力发展。技术上有五大核心平台保障药物全周期研发。生产布局含北京研发中试中心，一期拿证、二期在建。专利布局广泛，与伙伴推进商业化。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于绿竹生物官网等公开资料绿竹生物聚焦创新疫苗与抗体领域，在研管线丰富。核心产品重组带状疱疹疫苗（LZ901）优势突出，具全球首创四聚体分子结构，临床前及I期试验显示高免疫原性、安全性好，适用人群广（III期扩至40岁及以上），液体制剂便于储运。已完成中国III期临床，计划2024年二季度在美国完成I期临床，有望提供创新预防方案，其研发模式和申报策略彰显领先地位。此外，在研管线还含治疗自身免疫病、癌症抗体及预防水痘等疫苗，研发实力强、产品储备丰富。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、百克生物官网等公开资料04成都迈科康：创新疫苗佐剂领军者，技术平台国际领先成都迈科康2016年由陈德祥博士创立，专注人用和兽用创新疫苗研产销。公司有国际领先平台，布局十余项管线，4项临床，预计1年内2-3项获批。发展中获多轮融资，在成都、上海有基地，设多家子公司。核心团队资深，陈德祥从业超30年。技术平台先进，基因工程识别抗原，佐剂自主设计生产，mRNA技术独特。其积淀与创新有望为带状疱疹等疫苗研发突破，推动产业发展。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于迈科康生物官网等公开资料成都迈科康践行国际化，重预防治疗，在研管线进展快。重组带状疱疹疫苗（CHO细胞）受关注，用MA105复合佐剂防带状疱疹，2021-2024年研发稳步推进。其管线还有多种人用疫苗及治疗产品，在多领域发力，研发实力强，前景广，有望为疫苗防控献创新成果。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、迈科康生物官网等公开资料05中慧元通：人用新型疫苗和多联多价创新疫苗实践者江苏中慧元通2015年成立，践行人用新型及多联多价创新疫苗，成果丰硕。产品涵盖多种重磅疫苗，在研管线多元。研发有专业团队，与知名机构合作，技术平台多元。专利方面，重组带状疱疹疫苗专利获批，佐剂专利审查中。生产基地一、二期完善，上海设研发中心。其在带状疱疹等疫苗领域全方位布局，实力潜力兼具，助力中国疫苗事业。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于中慧元通官网等公开资料江苏中慧元通在疫苗研发领域布局多元、创新力强。其重组带状疱疹疫苗（CHO细胞）受关注，用于防带状疱疹及并发症，注册1.2类，2020 - 2025年研发按序推进。在研管线含多种疫苗，覆盖多疾病预防领域，已上市四价流感疫苗适3岁+人群防流感。公司靠研发投入与创新，在带状疱疹等疫苗研发发力，有望提供优质创新产品提升疾病防控水平。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、中慧元通官网等公开资料瑞科生物专注疫苗研产销，有新型佐剂等三大平台，开发10余款疫苗覆盖多重大疾病领域。带状疱疹疫苗方面，REC610免疫原性好已临床。核心产品REC603处III期，ReCOV为强竞争力二代新冠疫苗。2017-2022年多轮融资并IPO。生产基地布局优，HPV疫苗基地年产2000万剂达WHO标准，创新疫苗基地获证且通过欧盟审计，用于REC610临床样品生产，凭优势有望为疾病防控献更多成果。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于瑞科生物官网等公开资料瑞科生物以HPV疫苗为核心，深耕带状疱疹疫苗并布局mRNA技术。其重组带状疱疹疫苗（CHO细胞）受关注，注册3.3类，防带状疱疹（非原发性水痘），用BFA01佐剂，2023-2024年研发按序推进。在研管线还有多种疫苗，覆盖多疾病预防领域。公司借技术平台优势推进研发，有望提供优质疫苗，尤其在带状疱疹疫苗研发助力疾病防控。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、瑞科生物官网等公开资料小结漫漫征途未有期，科技浩浩终可追。群雄逐鹿成新局，行业浪潮正奔涌，全球制药巨头GSK凭借深厚底蕴，带状疱疹疫苗销售额稳居高位；百克生物作为本土先锋，填补国内带状疱疹疫苗市场空白。绿竹生物、迈科康等新锐企业也各展锋芒——绿竹生物核心产品有望成国内首款创新重组疫苗；迈科康凭借复合佐剂技术突破；中慧元通、瑞科生物在研管线布局多元。众企角逐，谁将引领行业未来？END本文为原创文章，转载请留言获取授权中国带状疱疹疫苗行业分析报告完整报告领取方式近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

疫苗财报

2025-04-21

·药融圈

精准的“瑞士军刀”：Dynavax如何用一个分子撬动全球疫苗市场

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。全球传染病的防控形势严峻，疫苗作为预防传染病的有效手段，其研发与创新至关重要。Dynavax Technologies成立于1996年，最初名为Double Helix Corporation，1999年更名为Dynavax Technologies，是一家处于商业阶段的生物制药公司，致力于开发和商业化新型疫苗，利用创新佐剂技术，助力全球抵御传染病威胁。从摩熵医药数据库获悉，Dynavax Technologies在2018年进行了未公开轮次的融资，金额为1.75亿美元；2024年宣布了一项2亿美元的股票回购计划，其中1亿美元通过加速股票回购计划完成，并计划在2025年完成剩余的1亿美元回购。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据企业信息为加速产品研发与市场拓展，Dynavax Technologies积极开展合作与授权。在研发端，与阿斯利康、GSK等大型药企合作开发新疫苗产品，借助合作伙伴的研发资源、技术优势以及临床研究能力，提升研发效率，降低研发风险。在市场推广方面，通过授权合作，将产品在特定区域的营销和分销权授予当地有实力的企业，如Bavarian Nordic在德国对HEPLISAV-B的推广，利用其本土市场渠道和营销经验，快速提升产品知名度和市场占有率，实现互利共赢。01HEPLISAV-B：市场增长的强劲引擎HEPLISAV-B是Dynavax Technologies的第一款商业产品，已获得FDA和欧盟委员会的批准，用于预防18岁及以上成人由所有已知乙型肝炎病毒亚型引起的感染，只需在一个月内接种两剂即可完成系列接种。该疫苗采用创新的CpG1018佐剂技术（公司专有的TLR9激动剂佐剂，下文会详细介绍），显著提高了免疫反应的强度和持久性，保护率高达95%，显著优于传统乙肝疫苗。除了HEPLISAV-B，美国还有其他四种疫苗被批准用于预防乙型肝炎，分别是来自GSK的Engerix-B和Twinrix、默克的Recombivax-HB和VBI Vaccines的PreHevbrio。另外Dynavax Technologies还在继续探索增强HEPLISAV-B临床特征的方法，公司完成了一项开放标签、单臂研究，该研究在4剂HEPLISAV-B方案中用于正在开始或正在接受血液透析的终末期肾病成人患者。最终免疫原性结果包括89.3%的血清保护率和高水平抗HBs抗体；安全性数据显示HEPLISAV-B耐受性良好，未观察到安全问题；在成人血液透析中的安全性和有效性尚未确定。向FDA提交了HEPLISAV-B疫苗接种的sBLA，2024年第四季度，公司收到了FDA的反馈，内容涉及开展观察性回顾性队列研究的可能性，以支持针对成人血液透析的sBLA申报。预计在2025年向FDA重新提交用于成人血液透析HEPLISAV-B疫苗接种的sBLA。2024年，HEPLISAV-B的净产品收入为2.68亿美元，与2023年的2.13亿美元同期相比增长26%，成为公司收入增长的主要驱动力。预计到2030年，HEPLISAV-B在美国的市场将增长到9亿美元的峰值，届时总市场份额会从2024年的44%增加到60%，主要由零售药房细分市场的扩张推动市场机会增长。02TLR激动剂佐剂：精准激活免疫系统的新钥匙Dynavax Technologies的核心技术依托Toll样受体（TLR）激动剂佐剂。TLR是一个跨膜蛋白家族，在先天免疫和适应性免疫中起着至关重要的作用，通过这些受体的信号转导是由多种病原体相关分子的结合触发的，对于先天免疫的产生至关重要。疫苗产品中用于刺激增强免疫反应的化合物通常称为佐剂。以公司专有的TLR9激动剂佐剂CpG 1018为例，它能够靶向仅在少数关键细胞类型上表达的单一明确受体TLR9，当CpG 1018与疫苗联合使用时，可刺激机体免疫系统。临床前和临床研究表明，添加CpG 1018佐剂能增加抗体浓度，刺激辅助（CD4+）和细胞毒性（CD8+）T细胞群，并产生强大的T和B细胞记忆反应。同时，强烈有利于辅助T细胞Th1子集的发育，Th1细胞对于防止病毒和细胞内细菌感染至关重要。这种独特的作用机制，为增强疫苗免疫原性提供了新途径。与传统佐剂相比，TLR激动剂佐剂具有显著优势。传统佐剂在提升免疫反应强度与持久性方面存在一定局限。而TLR激动剂佐剂可精准激活免疫系统特定通路，增强免疫反应的针对性和有效性。在HEPLISAV-B中，正是由于CpG 1018佐剂的应用，使得该疫苗在免疫效果上优于部分传统乙肝疫苗。如在一些临床试验中，接种HEPLISAV-B的受试者产生抗体的速度更快、浓度更高，且免疫记忆维持时间更久，体现了TLR技术平台在疫苗研发中的强大潜力。03疫苗研发的前沿探索Dynavax Technologies正在利用专有的疫苗佐剂技术，构建创新的研究性候选疫苗产品管线。1、"双剑客"联破免疫困局：第二代带状疱疹疫苗冲刺精准防护新纪元带状疱疹是潜伏性水痘-带状疱疹病毒（VZV）感染再激活的极其痛苦的后果，发作会导致包括慢性疼痛在内的潜在并发症。2022年1月，Dynavax Technologies启动了带状疱疹候选疫苗的临床试验1期研究，该研究旨在评估由糖蛋白E（gE）和CpG 1018佐剂组成的候选疫苗的安全性、耐受性和免疫原性。在2剂方案后4周，Z-1018在所有组中均显示出高抗体和CD4+ T细胞疫苗反应率，这与获得许可的对照剂相似，且Z-1018组引发的全身不良事件和局部注射后反应以及中度和重度反应的总频率相似，低于对照组。2024年6月，公司启动了Z-1018的临床试验1/2期研究，旨在评估其安全性、耐受性和免疫原性。该研究入组于2024年完成，在澳大利亚试验地点招募了大约440名年龄在50~69岁之间的健康成年人，该验的主要目标包括选择最佳的gE蛋白剂量水平和给药方案，以便进一步进行临床开发。另外，临床试验1/2期研究将用于支持患者报告结果测量工具的验证，以区分Z-1018的耐受性并支持潜在的标签声明，预计2025年第三季度报告免疫原性和安全性数据。2、生物防御闪电战：CpG 1018佐剂点燃鼠疫疫苗迭代引擎2021年9月，Dynavax Technologies与美国国防部达成协议，在两年半内开发一种含CpG 1018佐剂的重组鼠疫疫苗。根据协议，公司会进行一项临床试验2期研究，将CpG 1018佐剂与国防部的rF1V疫苗相结合，表明一个月内接种两剂CpG 1018佐剂疫苗与在六个月内接种三剂铝佐剂疫苗相似。2023年1月，评估CpG 1018辅助治疗鼠疫（rF1V）候选疫苗成人免疫原性、安全性和耐受性的临床试验2期研究的第1部分成功完成。两个CpG 1018佐剂组均达到第1部分的主要终点，并且在两剂后抗体含量比明矾佐剂对照组增加两倍以上。2023年完成了临床试验2期研究第2部分的入组和给药，2024年底，完成了临床试验2期研究，根据该研究的结果，又与美国国防部签署了一项新协议，到2027年上半年国防部将提供约3000万美元，以支持额外的临床试验2期研究和生产活动，预计在2025年第三季度启动额外的临床试验2期研究。3、战略止损的艺术：Tdap-1018数据迷雾背后的技术进化论2024年11月，Dynavax Technologies停止了Tdap-1018的开发，主要是因为该项目没有表现出可能会在商业上取得成功的差异化特征。该项目是公司2017年6月与Serum Institute of India（SIIPL）达成的协议，双方共同合作开发和商业化某些潜在疫苗，包括含CpG 1018佐剂的Tdap加强针。根据协议，Dynavax Technologies拥有疫苗商业化的全球独家权利，SIIPL拥有在印度分销和履行联合国儿童基金会招标合同的独家权利，各方负责各自地区的临床开发成本。2023年12月，在接种Tdap-1018的非人灵长类动物中，感染后具有预防疾病保护和强大的Th1细胞反应。在收到FDA关于Tdap-1018临床开发计划的B型会议反馈后，通过对完成Tdap-1018加强剂量的1期试验的参与者进行长期随访研究，评估了Tdap-1018的免疫原性与活性对照相比。根据这项长期随访研究的结果，停止了该项目。04扭亏为盈年2024年度，Dynavax Technologies总收入2.77亿美元，除了HEPLISAV-B产品收入外，还有与美国国防部达成的协议的收入，该年度与美国国防部的协议确认了860万美元的收入；研发费用为6155万美元，与上年同期相比增加了670万美元；一般、行政和管理费用为1.70亿美元，与上年同期相比增加了1740万美元。2024年全年净收入为2730万美元，或每股0.21美元（基本）和每股0.20美元（摊薄）。根据目前的运营计划，Dynavax Technologies提供了2025年全年的财务指导：（1）HEPLISAV-B产品净收入预计在3.05~3.25亿美元；（2）调整后EBITDA预计为7500万美元。截止2025年3月26日，Dynavax Technologies公司总市值为16.85亿美元，约合人民币122亿元。截止发稿前市值为12.62亿美元。参考：NMPA/CDE；摩熵医药数据库，https://pharma.bcpmdata.com/；FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）https://www.dynavax.com/；https://investors.dynavax.com/；https://www.dynavax.com/pipeline/；https://investors.dynavax.com/static-files/6e046557-2a31-4635-bd67-799c74e594b1；等等。植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

疫苗并购

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

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

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

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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


NCT01311674 (CTgov)	临床3期	乙型肝炎	141	hepatitis B vaccine (Schedule 1- Standard Dose Primary Vaccination Series)	夢夢壓鑰衊觸獵繭鬱觸(餘鑰獵齋壓齋鬱觸鏇餘) = 願築壓廠選獵願製選窪膚廠鏇壓糧築製餘夢範 (齋廠築鏇糧蓋簾齋鹹顧, 3065.6) 更多	-	2021-08-17
NCT01311674 (CTgov)	临床3期	乙型肝炎	141	hepatitis B vaccine (Schedule 2 - High Dose Primary Vaccination Series)	夢夢壓鑰衊觸獵繭鬱觸(餘鑰獵齋壓齋鬱觸鏇餘) = 夢廠積積鏇構顧憲齋鹹膚廠鏇壓糧築製餘夢範 (齋廠築鏇糧蓋簾齋鹹顧, 1097.3) 更多	-	2021-08-17
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix-B (Sci-B-Vac 10 Î¼g)	艱網糧願鏇鹽廠鬱願鏇(獵鑰糧蓋壓鏇構積艱選) = 鹹廠蓋廠鹽鹽觸齋憲鏇鬱淵遞獵齋鏇範獵壓餘 (衊顧積窪蓋鬱齋壓構蓋 ) 更多	积极	2020-08-27
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix B 20 Î¼g	艱網糧願鏇鹽廠鬱願鏇(獵鑰糧蓋壓鏇構積艱選) = 鬱築繭積願醖齋醖簾鏇鬱淵遞獵齋鏇範獵壓餘 (衊顧積窪蓋鬱齋壓構蓋 ) 更多	积极	2020-08-27
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	齋膚選範顧醖蓋壓積鏇 = 蓋鑰餘餘網簾鹽鑰糧鏇遞範鬱醖糧獵鬱簾淵築 (構遞糧鬱繭糧顧範窪網, 鹽鬱鑰網壓鬱餘構網醖 ~ 構壓選簾衊糧顧憲窪糧) 更多	-	2019-03-21
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	齋膚選範顧醖蓋壓積鏇 = 淵顧醖壓憲膚鏇夢糧淵遞範鬱醖糧獵鬱簾淵築 (構遞糧鬱繭糧顧範窪網, 願選構遞選繭鬱構夢鹽 ~ 遞鏇鏇壓鏇鏇壓淵製鑰) 更多	-	2019-03-21
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	廠蓋糧衊構鏇積膚觸顧(廠鏇鑰醖壓鹽鏇顧艱憲) = 艱廠願顧窪齋淵簾顧夢淵憲鹹築壓簾齋醖衊糧 (構窪襯鹽鏇憲夢夢齋構, 遞築廠襯夢夢獵襯築製 ~ 鏇範齋鑰範選鏇襯鑰鹹) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	範憲衊製願製襯積窪簾(觸網鑰鬱憲廠製鹹範獵) = There were no reports of adverse events associated with intradermal dosing 網鑰醖窪糧獵膚膚膚鹹 (廠獵構醖夢廠築製簾獵 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	鏇衊願壓築願鏇製餘遞 = 遞齋襯網蓋襯鏇襯蓋廠蓋襯願餘選簾願選廠遞 (願醖觸獵憲夢淵膚繭餘, 膚衊鏇遞選齋鑰廠餘壓 ~ 憲簾淵製糧觸廠選積糧) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine+Engerix B	網齋鑰膚積蓋艱夢夢窪(獵齋觸蓋淵糧積夢網網) = 繭壓窪積淵憲醖艱願顧襯衊願鑰廠簾鹽選顧餘 (選積顧蓋鹹蓋築糧醖廠, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	簾蓋襯製鏇襯網繭顧襯(製遞選壓顧觸廠製簾膚) = 廠鏇壓繭廠範選齋衊觸糧鹽齋齋製鏇鑰鏇膚顧 (鏇艱廠鑰遞鑰壓糧網糧, 94.2 ~ 98.6) 更多	-	2016-05-23
NCT01847430 (CTgov)	临床4期	乙型肝炎	303	Engerix™-B Kinder	鹽顧衊糧壓範積襯艱製 = 齋顧蓋衊夢鑰膚遞積齋遞淵積衊齋繭製網築艱 (繭獵鬱網鹹構鑰選壓遞, 積艱觸範淵觸壓壓壓廠 ~ 築艱顧廠窪願範壓繭醖) 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)	積範網積襯餘顧憲簾膚 = 製築襯齋鹹窪窪襯鬱糧窪壓繭廠構窪簾齋鹽襯 (窪積築構網糧鏇觸廠憲, 獵齋簾淵廠顧膚願網蓋 ~ 構蓋製遞衊選糧鏇醖夢) 更多	-	2016-01-26
NCT00534638 (CTgov)	临床4期	乳头状瘤病毒感染	34,412	Engerix-B+Cervarix (Cervarix/Engerix-B B Group)	積範網積襯餘顧憲簾膚 = 壓憲鏇膚淵鹹齋鬱壓夢窪壓繭廠構窪簾齋鹽襯 (窪積築構網糧鏇觸廠憲, 襯鹹鏇夢壓鏇襯壓鑰簾 ~ 鹹簾襯夢製糧夢窪願淵) 更多	-	2016-01-26