B群脑膜炎球菌疫苗(Novartis Pharma AG)(Meningococcal group B vaccine(GlaxoSmithKline Biologicals SA)) - 在研适应症：脑膜炎，脑膜炎球菌感染_专利_临床

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

MenB、MenB+OMV NZ、Meningococcal B recombinant vaccine

+ [8]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病

在研适应症

脑膜炎脑膜炎球菌感染

非在研适应症

传染性红斑遗传性补体缺乏病内脏异位综合征+ [1]

原研机构

Novartis AG

在研机构

GlaxoSmithKline Vaccines Srl

GSK PlcGlaxoSmithKline, Inc.

+ [1]

非在研机构

Novartis AGNovartis Vaccines & Diagnostics, Inc.

权益机构

GSK Plc

Pfizer Inc.

Novartis AG

最高研发阶段批准上市

首次获批日期

欧盟 (2013-01-13),

脑膜炎球菌感染

最高研发阶段(中国)临床申请

特殊审评-

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结构/序列

Sequence Code 6741

Sequence Code 58469

Sequence Code 23917

关联

68

项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的临床试验

NCT06832514

/ Recruiting临床4期IIT

An Investigator-initiated, Single-center Academic Study in Healthy Transgender and Cisgender Persons Aged Between 18 and 40 Years to Investigate Gender and Sex Differences in Immune Responses to Meningococcal Serogroup B Vaccination

Sexual differences are a well-established source of biological variation in immune system functioning, with men often displaying lower adaptive immune responses (e.g. antibody production) to infections and vaccinations compared to women. The impact of sex and gender on immune responses and immune functioning warrants more in-depth investigation. This study is an investigator-initiated project aimed at prospectively assessing the immune response towards a vaccine in transgender and cisgender individuals. Transgender individuals retain their chromosomal sex while undergoing a significant hormonal shift that aligns with their experienced gender. Immune responses induced by the four-component meningococcal serogroup B (4CMenB; Bexsero®) vaccine will be evaluated in transgender individuals and compared with responses observed in cisgender individuals. Both humoral and cellular immune responses induced by two doses of the 4CMenB vaccine will be quantified and analysed. This approach is expected to provide new insights into the effects of gender and sex differences on innate and adaptive immune responses.

开始日期2025-01-31

申办/合作机构

Ghent University

[+1]

NCT06647407

/ Recruiting临床1/2期

A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

开始日期2024-11-05

申办/合作机构

Sanofi Pasteur SA

NCT06446752

/ Recruiting临床3期IIT

A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women

This proposed 2-arm randomized evaluation of two doses of 4CMenB vaccine versus placebo at Enrollment and Month 2 is designed as a proof-of-concept study to inform potential use for dual meningococcal B and gonococcal prevention, and to inform Neisseria gonorrheae vaccine development.

开始日期2024-08-14

申办/合作机构

University of Washington

[+2]

100 项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的临床结果

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100 项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的转化医学

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100 项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的专利（医药）

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606

项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的文献（医药）

2025-12-31·Emerging Microbes & Infections

Genomic characterization of invasive Neisseria meningitidis in Spain (2011/12–2022/23): expansion of clonal complex 213 and the potential threat to 4CMenB vaccine strain coverage

Article

作者: Galán-Ladero, M. Ángeles ; Mir-Cros, Alba ; Orellana, M. Ángeles ; Puigsech-Boixeda, Guillem ; Pérez-Argüello, Amaresh ; Càmara, Jordi ; Cercenado, Emilia ; Viñado, Belén ; Sarvisé, Carolina ; Larrosa, Nieves ; Rodriguez-Fernandez, Ana ; Martín-Nalda, Andrea ; Lung, Mayli ; Roca-Grande, Josep ; Quesada, M. Dolores ; Palop, Begoña ; González-López, Juan José ; Ruiz de Gopegui, Enrique ; Muñoz-Almagro, Carmen ; Bellés-Bellés, Alba ; Rivera, Alba ; Soler-Garcia, Aleix ; Moreno-Mingorance, Albert ; Navarro de la Cruz, Daniel

Invasive meningococcal disease (IMD) is associated with significant global morbidity and mortality and is addressed by conjugated polysaccharide and subcapsular vaccines. In Spain, data on 4CMenB vaccine strain coverage and antimicrobial susceptibility are limited. This study aimed to describe the genomic epidemiology, predict 4CMenB vaccine strain coverage, and assess antimicrobial susceptibility of 323 Neisseria meningitidis isolates causing IMD, collected from 57 Clinical Microbiology Laboratories in Spain over 12 years (2011/12-2022/23). Whole genome sequencing was performed to identify serogroup, clonal complex (cc), and antimicrobial resistance determinants. Vaccine strain coverage for serogroup B (MenB) isolates was predicted using the genetic Meningococcal Antigen Typing System approach. The most prevalent serogroups were B (57.9%), W (21.4%), C (10.4%), and Y (8.4%). MenB predominated throughout most seasons, except during the 2019/20 season when serogroup W peaked. Post-COVID-19 pandemic, MenB remained the most frequent (70.2%). Thirteen cc were identified among MenB isolates, with cc213 being the most prevalent (40.1%). Only 28.9% of MenB isolates were predicted to be covered by 4CMenB, with cc213 showing an exceptionally low coverage rate (5.3%) due to antigenic variants poorly targeted by the vaccine. Notably, cc213 was responsible for twice the proportion of MenB cases in 4CMenB-vaccinated versus unvaccinated. All isolates were susceptible to third generation cephalosporins, and 13.5% showed penicillin resistance. This study highlights the alarming prevalence of cc213 among MenB IMD cases in Spain and the limited 4CMenB coverage against this cc. The disproportionate representation of cc213 in vaccinated individuals underscores its potential to compromise vaccine effectiveness.

2025-12-31·Human Vaccines & Immunotherapeutics

Meningococcal vaccination disparities in the United States (2010–2021): Findings from the National Immunization Survey-Teen and a commercial insurance database

Article

作者: Ganz, Michael L. ; Kocaata, Zeki ; Huse, Samuel ; Kwiatkowska, Marta ; Herrera-Restrepo, Oscar ; Ndegwa, Nelson

In the United States, while meningococcal vaccines are available and recommended for adolescents and young adults, coverage remains low and disparities persist. We evaluated meningococcal serogroups A, C, W, Y (MenACWY) and B (MenB) vaccine uptake, completion, and compliance using a cross-sectional analysis of National Immunization Survey-Teen (NIS-Teen) data (2015-2021) and a cohort analysis of commercial claims data (2010-2021). Regression models were used to identify factors associated with vaccine uptake. Included in the NIS-Teen MenACWY and MenB analyses were 138,952 and 177,077 patients, respectively. Included in the claims MenACWY and MenB analyses were 953,905 and 818,424 patients, respectively. In 2021, MenACWY uptake was 86.4% (95% confidence interval [CI]: 83.6-88.8%) among ≤13-year-olds (NIS-Teen) and 63.2% (62.8-63.5%) among 11-12-year-olds (claims). MenB was 33.7% (30.5-37.1%) among ≤17-year-olds (NIS-Teen), 41.6% (41.2-42.0%) among 16-18-year-olds (claims), and 15.0% (14.7-15.4%) among 19-23-year-olds (claims). The states with the lowest and highest MenB uptake by ≤17-year-olds in 2021 (NIS-Teen) were Minnesota (10.1% [3.9-23.6%]) and North Dakota (69.9% [52.1-83.2%]). Factors associated with MenACWY uptake included living in a state with a vaccine mandate, Black or Hispanic race (versus White), and well-child visit attendance. Factors associated with MenB uptake included having Medicaid (versus private insurance) and Hispanic race (versus White). The findings suggest that meningococcal vaccination coverage disparities persist across vaccines, age, geography, and race and ethnicity. Higher MenACWY (versus MenB) coverage suggests the benefit of routine recommendations. Annual well-child visits and simplified vaccination schedules could reduce vaccination access barriers.

2025-12-31·Human Vaccines & Immunotherapeutics

Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial

Article

作者: Martinon-Torres, Federico ; Peyrani, Paula ; Jodar, Luis ; Natalini Martinez, Silvina ; Liberator, Paul A. ; O’Neill, Robert ; Trammel, James ; Lamberth, Erik ; Beeslaar, Johannes ; Gruber, William C. ; Oladipupo, Islamiat ; Anderson, Annaliesa S. ; Maguire, Jason D. ; Zolotas, Lefteris ; Salamanca de la Cueva, Ignacio

Invasive meningococcal disease is an uncommon but serious disease predominantly affecting children. This phase 2b study evaluated MenABCWY in 6-month-old infants followed by MenB-fHbp and MenABCWY in 2-month-old infants, the latter being the target age and intervention. Participants were randomized to MenABCWY, 60 µg or 120 µg MenB-fHbp+MenACWY-TT, or 4CMenB+MenACWY-TT, administered as 2 primary and 1 booster dose. The primary safety objective was to describe the safety profile of MenABCWY in participants enrolled at 2 months. Primary immunogenicity objectives were the percentage of participants achieving seroprotective serum bactericidal antibody using human complement titers. Overall, 314 and 12 participants were randomized to sentinel cohort and open-label expanded-enrollment stages, respectively. Based on 2 reports of fever requiring invasive investigations and accompanied by cerebrospinal fluid pleocytosis and 1 report arising from a previous study, the Sponsor terminated the study. Local reactions and systemic events after primary vaccination were generally mild to moderate, and tended to be higher with MenABCWY versus 4CMenB+MenACWY-TT. Immunogenicity data suggest that 1 month after vaccination 2, MenABCWY responses for MenA/C/W/Y were robust and comparable with 4CMenB+MenACWY-TT in 2-month-old participants. Immune responses for MenB test strains were higher with MenABCWY versus 4CMenB+MenACWY-TT and generally similar with 60 µg and 120 µg MenB-fHbp+MenACWY-TT or MenABCWY. Based on the limited results, the consistency of MenB immune responses with 60 µg and 120 µg MenB-fHbp suggests doses < 60 µg could be investigated to assess whether a more acceptable safety profile in conjunction with beneficial immune responses is possible in 2-month-old infants.

96

项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的新闻（医药）

2025-04-30

·药时空

GSK Q1：全年营收超 95 亿美元，肿瘤收入大涨 53%

4 月 30 日，葛兰素史克（GSK）发布 2025 年 Q1 财报，全年营收 75.16 亿英镑（95.04 亿美元），同比增长 4%（按固定汇率计算，下同）。研发投入 14.62 亿英镑（18.49 亿美元），同比增长 3%。来源：GSK 官网（下同）GSK 的业务主要分为特药（Specialty Medicines）、疫苗（Vaccines）以及普药（General Medicines）三个版块，2025 年 Q1 分别贡献了 29.33 亿英镑（37.10 亿美元，+17%）、20.95 亿英镑（26.48 亿美元，-6%）、24.88 亿英镑（31.46 亿美元，稳定）的业绩收入。具体来说，特药方面，GSK 在HIV、呼吸/免疫和肿瘤疾病领域分别斩获了 17 亿英镑（+7%）、8 亿英镑（+28%）、4 亿英镑（+53%），增长迅猛，尤其是肿瘤产品，已经成为 GSK 业绩新的增长点。GSK 肿瘤板块增长主要得益于骨髓纤维化贫血患者药物 Ojjaara/Omjjara（莫洛昔尼，2023 年 9 月上市）的推出，以及 PD-1 单抗 Jemperli（Dostarlimab，2021 年 4 月上市）新适应症的拓展和市场渗透程度的增加，两款产品 2025 年 Q1 销售额分别为 1.12 亿英镑和 1.74 亿英镑，2 款产品的同比增长率均大于 100%。呼吸/免疫领域，Nucala （美泊利珠单抗）和 Benlysta（贝利尤单抗）分别为 GSK 贡献了 4.44 亿英镑（+21%）和 3.59 亿英镑（+39%）的销售额。HIV 领域，GSK 手握长效产品，市场表现不俗，销售额持续增长。其中 Cabenuva（卡替拉韦+利匹韦林）、Apretude （卡替拉韦）和 Dovato （多替拉韦+拉米夫定）分别获得了 2.94 亿英镑（+38%）、0.89 亿英镑（+63%）和 5.7 亿英镑（+19%）的收入。疫苗方面，GSK 产品销售陷入疲软期，收入 20.95 亿英镑，仅脑膜炎疫苗实现了两位数增长，被寄予厚望的 RSV 疫苗 Arexvy 遭受腰斩。Arexvy 在 2023 年 5 月首次获 FDA 批准，随后又相继在欧盟、日本获批上市。作为全球首款 RSV 疫苗，Arexvy 在上市第一年便成功斩获了 15.43 亿美元的销售额。但 2024 年，由于需求下降，该产品全球销售额下滑 51%，仅有 5.90 亿英镑的收入。2025 年 Q1 销售额达 0.78 亿英镑，同比下滑 57%。Shingrix 是一款重组带状疱疹疫苗，2024 年以 33.64 亿英镑（+1%）的收入继续稳坐全球疫苗大品种的宝座。2025 Q1 该产品的销售额为 8.67 亿英镑，同比下滑 7%。脑膜炎疫苗 Meningitis（包括 Bexsero 和 Menveo ）增长强劲，为 GSK 疫苗板块注入了新的动力，2025 年 Q1 斩获了 3.5 亿英镑的销售额，同比增长 20%。GSK 在财报中披露，预计 2025 年 FDA 将批准 5 项主要新产品：2025 年第一季度批准：Penmenvy，脑膜炎疫苗；Blujepa，用于治疗尿路感染的首创抗生素预计进一步获批的药物包括：Nucala（慢性阻塞性肺病）；Blenrep（多发性骨髓瘤）；以及 Depemokimab（严重哮喘和鼻息肉）识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

财报疫苗上市批准

2025-04-24

·Delonix Bioworks

世界免疫周 | 守护健康，共筑免疫长城

世界卫生组织（WHO）将每年4月的最后一周定为世界免疫周，目的是汇集各合作伙伴，建立广泛联盟，强调免疫接种对于减少疾病、挽救生命的重要性。2025年世界免疫周的主题是“人人享有免疫服务，我们可以做到”，努力确保更多儿童、青少年、成年人及其社区免受疫苗可预防疾病的威胁。01免疫接种是人类最伟大的成就之一自1974年全球大规模免疫接种计划启动以来，疫苗已拯救了全球1.54亿人的生命，平均每分钟就有6条生命得以挽救。疫苗可预防30多种威胁生命的疾病，如麻疹、白喉、霍乱等。过去50年间，疫苗接种为婴儿存活率的提升贡献了40%的增幅。如今，儿童存活至一岁及一岁以上的比例高于人类历史上任何时期。疫苗接种不仅能拯救生命，还能有效遏制致命疫情的暴发。疫情一旦暴发，应对的成本高昂且低效，还会徒增生命风险。预防才是长久之计。我们应确保所有人从出生到老年，在生命的各个阶段都能及时接种适当的疫苗。按时接种每一剂疫苗至关重要，等到疫情暴发后再接种则为时已晚。一旦疫情暴发，可能来不及接种所需全部剂次疫苗来保护自己和家人，自己或亲人可能会受到感染。02破除壁垒，迈向免疫平等随着科技的飞速发展，如今市场上涌现出众多创新且高效的疫苗。然而，世界卫生组织的最新研究揭示了一个令人痛心的现实：HPV疫苗、带状疱疹疫苗等新型疫苗在低收入国家的覆盖率，普遍低于高收入国家的20%，部分疫苗品类的差距甚至超过10倍。这些新型疫苗的推广之路，因生产工艺复杂、成本高昂以及菌株覆盖不足等诸多因素，难以触及更广阔的地区。以GSK的B群脑膜炎球菌疫苗Bexsero为例，其采用细菌外膜囊泡（outer membrane vesicle，OMV）创新技术路径研发，为全球唯二上市的MenB疫苗。Bexsero凭借卓越的保护效力和安全性，多年来稳居全球前十畅销疫苗之列，2024年销售额达13亿美元，位居全球疫苗畅销榜第七。Bexsero上市十余年来为全球从婴儿到成人的广泛人群提供了切实有效的保护，以英国为例，其2015年9月首次将Bexsero纳入常规免疫规划，短短3年后，英国婴幼儿B群流脑疾病的发病率便下降了75%。然而，Bexsero复杂的工艺链，包括高速离心等工序，不仅形成了难以跨越的技术壁垒，更推高了生产成本，导致销售价格居高不下（每剂价格超200美元）。因此，尽管已上市十余年，Bexsero的销售范围仍主要集中在欧美等发达国家和地区。2025年世界免疫周的主题是：“人人享有免疫服务，我们可以做到（Immunization for All is Humanly Possible）”。为了守护人类这一最伟大的成就，我们必须坚定地、平等地为所有人提供疫苗，并进一步努力保护各年龄段、各地区的人群免受疫苗可预防疾病的威胁。为此，开发并引入低成本的创新疫苗，对于抗击顽固疾病、帮助全球应对未来未知健康威胁，显得至关重要。03羽冠生物对世界免疫平等的努力和承诺羽冠生物作为专注于合成生物学创新细菌疫苗研发的先锋企业，肩负着推广“疫苗平等”的重要使命。凭借其资深疫苗研发团队和合成生物学专家20余年的深厚积累，羽冠生物在病原菌基因编辑领域积累了丰富的经验和卓越的能力。基于此，公司成功打造了PathX病原菌编辑平台，为细菌疫苗领域的病原菌编辑提供了一站式解决方案。结合最具潜力的下一代细菌疫苗技术OMV，羽冠生物特别推出新一代基因工程细菌外膜囊泡疫苗平台——OMV Plus。通过全球领先的病原菌基因组编辑技术，成功突破了传统OMV设计和生产中的多个技术瓶颈，显著提升了疫苗的安全性和效力，大幅降低生产成本。其中，羽冠生物的B群脑膜炎球菌OMV疫苗，凭借其卓越的临床前数据，在多维度分析中已展现出成为该品类中最优产品的巨大潜力。目前，该疫苗已成功实现100L规模的放大生产（单批次产量超100万剂），使羽冠生物成为全球少数能实现OMV疫苗商业化量产的企业之一。更重要的是，羽冠生物实现了单剂生产成本低于1美元，相比现有上市产品实现了显著的成本下降，为B群脑膜炎疫苗实现全球免疫平等奠定了坚实基础。该管线即将申报IND，有望为全球疫苗接种事业带来新的突破。在这个世界免疫周，让我们携手共进，推动低成本、高效创新疫苗的研发与普及，为全球健康事业贡献力量，守护每一个人的生命安全和身体健康。关于羽冠生物羽冠生物是一家全球领先的创新细菌疫苗研发企业，致力于通过合成生物学技术推动细菌疫苗开发从经验路径向理性化设计转变。公司总部位于上海张江科学城，拥有一支平均具备15年以上学术及产业经验的资深管理团队。公司自主研发的PathX病原菌基因组编辑平台在全球处于领先地位，可实现对超过15种病原菌的高效基因组编辑。基于该平台，公司开发了创新的工程化OMV技术平台（OMV Plus）等多项疫苗技术平台。目前公司已建立了多个具有重大市场潜力的创新细菌疫苗管线，其中B群脑膜炎球菌OMV疫苗的临床前研究数据显示出全球最优的潜力，预计将于2025年提交临床试验申请。凭借突出的创新实力，羽冠生物已获得包括勃林格殷格翰创新大赛冠军在内的十余项国内外重要荣誉，并入选上海市"专精特新"中小企业。欲了解更多信息，请访问https://delonixbio.com/

疫苗免疫疗法

2025-04-22

·Delonix Bioworks

Delonix Bioworks and WuXi Vaccines Form Strategic Partnership

Delonix Bioworks and WuXi Vaccines Form Strategic Partnership to Accelerate Global Application of Innovative OMV Vaccine TechnologyOn April 21st, 2025, Delonix Bioworks, a global pioneer in innovative bacterial vaccine development, and WuXi Vaccines, a leading global vaccine Contract Development and Manufacturing Organization (CDMO), today announced a strategic partnership. Through the collaboration, Delonix Bioworks will leverage WuXi Vaccines' integrated development and manufacturing capabilities as well as the world-class quality system to advance its next-generation engineered Outer Membrane Vesicle (OMV) technology platform, OMV Plus, driving its widespread adoption for bacterial vaccines. Together, the companies will jointly facilitate innovation in bacterial vaccines, contributing to the protection of public health worldwide.Engineered OMV represents the most promising next-generation bacterial vaccine technology. As natural nanovesicles released by gram-negative bacteria, OMVs carry numerous bacterial antigens—including proteins and polysaccharides—which effectively solves the challenge of screening optimal antigens for bacterial vaccines. And their commercial applications have been validated in the market. Additionally, OMVs contain rich pathogen-associated molecular patterns (PAMPs), providing a built-in adjuvant effect that enhances vaccine potency without requiring additional adjuvants. Pathogen genome editing is crucial for OMV vaccine applications as it eliminates safety concerns such as endogenous pyrogens while significantly increasing yield and coverage. This technology enables vaccine development for the majority of gram-negative bacteria.Delonix Bioworks launched its OMV Plus platform in 2023, overcoming key technical bottlenecks in traditional OMV design and production through its leading pathogen genome editing technology. This breakthrough significantly enhanced vaccine safety and efficacy while reducing production costs. Through collaboration with WuXi Vaccines, the company achieved GMP-scale production of engineered OMV vaccines within 10 months, reaching over 1 million doses per 100L fermentation batch at less than $1 per dose—establishing a strong foundation for expanding the strategic partnership between the two companies.Dr. Qiubin Lin, founder and CEO of Delonix Bioworks"We are delighted to announce the strategic partnership with WuXi Vaccines, aimed at accelerating global access to novel bacterial vaccine technologies. After a year of intensive collaboration, marked by dedicated efforts and innovative approaches from both teams, we have combined Delonix Bioworks' robust vaccine innovation capabilities with WuXi Vaccines' in-depth know-how and expertise in vaccine CMC and manufacturing to achieve a landmark milestone – successfully scaling up the production of China's first MenB OMV vaccine at an unprecedented pace. This partnership not only enables significant improvements in productivity and manufacturing cost reduction, but also underscores Delonix Bioworks’ global leadership in pathogen genome capabilities and our shared commitment to enhancing the accessibility of novel bacterial vaccines."Mr. Jian Dong, CEO of WuXi Vaccines"We sincerely appreciate Delonix Bioworks’ longstanding trust in us. This strategic collaboration reaffirms WuXi Vaccines' value in expediting innovative vaccine development through our integrated platforms that uphold the utmost quality standards. Through this collaboration, both parties will fully leverage our combined strengths in OMV vaccine R&D, process development, and large-scale manufacturing to accelerate the research and commercialization of innovative bacterial vaccines for a broader range of global partners. WuXi Vaccines remains committed to meeting the growing demand for vaccine development and manufacturing services with our profound expertise and comprehensive end-to-end solutions, thereby improving the accessibility and affordability of vaccines worldwide to protect public health."About Delonix Bioworks Delonix Bioworks is a leading biotech pioneering innovative bacterial vaccine development, transforming the field from empirical approaches to rational design. Founded by pioneers in synthetic biology and vaccinology, we have developed comprehensive genome editing toolkits for over 15 pathogens and established multiple proprietary vaccine technology platforms. Our flagship OMV Plus platform is a state-of-the-art engineered technology that produces OMV vaccine candidates with enhanced efficacy and safety profiles. It enables scalable, cost-effective production and significantly accelerates the development timeline. This platform powers our Meningococcal Group B vaccine candidate, which shows best-in-class profiles and is approaching IND submission in 2025.Delonix Bioworks has won multiple awards in China and globally, including the Champion in Boehringer Ingelheim Innovation Prize. For more information, please visit https://delonixbio.com/About WuXi Vaccines WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine and preventive antibody’s development and manufacturing. It provides world-class, integrated development and manufacturing platforms to expedite partners’ vaccines to the clinical stage and the market, regardless of the vaccine modality (i.e., recombinant protein, viral, viral vectored, VLP, OMV, nucleic acid, conjugated vaccines). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (cell culture, viral, microbial, polysaccharide and protein conjugation), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine development to large-scale commercial production and distribution. The company can enable global clients to deliver critical vaccines anywhere in the world, making it an essential partner in protecting public health.For more information about WuXi Vaccines, please visit: https://wuxivaccines.com

疫苗临床研究

100 项与 B群脑膜炎球菌疫苗(Novartis Pharma AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH09	-

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
脑膜炎	加拿大	GSK Plc	2014-02-26
脑膜炎球菌感染	欧盟	GSK Plc	2013-01-13
脑膜炎球菌感染	列支敦士登	GSK Plc	2013-01-13
脑膜炎球菌感染	冰岛	GSK Plc	2013-01-13
脑膜炎球菌感染	挪威	GSK Plc	2013-01-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
内脏异位综合征	临床前	西班牙	Novartis AG	2014-05-01
内脏异位综合征	临床前	意大利	Novartis AG	2014-05-01
脑膜炎球菌感染	临床前	美国	Novartis AG	2013-11-01
传染性红斑	临床前	西班牙	GSK Plc	2013-06-01
传染性红斑	临床前	匈牙利	GSK Plc	2013-06-01
流行性脑脊髓膜炎	临床前	芬兰	GSK Plc	2008-03-01
流行性脑脊髓膜炎	临床前	奥地利	GSK Plc	2008-03-01
流行性脑脊髓膜炎	临床前	意大利	GSK Plc	2008-03-01
流行性脑脊髓膜炎	临床前	德国	GSK Plc	2008-03-01
流行性脑脊髓膜炎	临床前	捷克	GSK Plc	2008-03-01

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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


NCT04318548 (CTgov)	临床3期	脑膜炎球菌感染	945	Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)+Placebo+Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (MenB+MenACWY Group)	簾顧糧齋範壓壓醖選獵(遞製廠製選繭鹹膚淵觸) = 鏇鹽艱繭廠簾構齋憲鹹淵糧蓋積遞糧鹽構鹹壓 (願網網壓鹽齋壓衊憲夢, 糧餘憲淵廠觸築網憲膚 ~ 鹹鹹壓夢築遞廠範衊鹹) 更多	-	2025-03-04
				Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)+Placebo+Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (MenB Group)	簾顧糧齋範壓壓醖選獵(遞製廠製選繭鹹膚淵觸) = 壓壓鏇艱廠鬱艱淵夢餘淵糧蓋積遞糧鹽構鹹壓 (願網網壓鹽齋壓衊憲夢, 簾築夢範窪窪糧觸繭願 ~ 淵積齋廠遞艱觸壓衊簾) 更多
NCT04722003 (CTgov)	临床2期	淋病	52	Meningococcal Group B Vaccine (4CMenB)	積鹽醖衊築糧鹹簾範餘(壓艱廠鹽顧願築艱廠憲) = 艱積觸襯醖鏇廠憲鹽鬱窪築衊衊窪顧鬱鹹製衊 (夢襯壓遞鬱積襯鑰顧夢, 醖淵鑰憲醖鑰鏇遞壓壓 ~ 獵醖觸壓簾鏇鬱鹽獵鹹) 更多	-	2024-11-05
				Placebo (Placebo)	積鹽醖衊築糧鹹簾範餘(壓艱廠鹽顧願築艱廠憲) = 壓夢壓觸蓋廠壓膚壓憲窪築衊衊窪顧鬱鹹製衊 (夢襯壓遞鬱積襯鑰顧夢, 醖衊餘壓餘夢選蓋鹹襯 ~ 餘鹹夢觸網範廠遞齋積) 更多
NCT04502693 (CTgov)	临床3期	脑膜炎球菌感染	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_2_6 Group)	製壓鹹範廠鏇壓選餘網(積選網遞齋憲鏇襯積襯) = 醖膚觸構鹽鹽夢遞膚鑰鬱顧憲衊醖窪觸遞蓋窪 (醖衊齋壓餘醖選糧顧簾, 獵構網糧鏇廠簾鑰齋艱 ~ 餘範獵顧窪壓遞衊築糧) 更多	-	2024-03-05
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_6 Group)	製壓鹹範廠鏇壓選餘網(積選網遞齋憲鏇襯積襯) = 鏇廠簾製積製製艱餘衊鬱顧憲衊醖窪觸遞蓋窪 (醖衊齋壓餘醖選糧顧簾, 窪憲繭鹽積網鬱顧蓋衊 ~ 獵壓憲選顧願製壓網蓋) 更多
NCT03632720 (CTgov)	临床3期	脑膜炎球菌感染	788	Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months))	膚餘願夢窪構醖醖窪鹹(鬱廠鬱鏇積艱艱顧築構) = 蓋構鏇鹹簾鹽觸醖襯膚願獵顧願鬱糧製鑰壓壓 (壓構鹹構築鬱鑰網積網, 餘網鬱鹽鏇繭鬱襯憲範 ~ 製遞願築糧壓獵積鑰網) 更多	-	2023-11-07
				Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months))	膚餘願夢窪構醖醖窪鹹(鬱廠鬱鏇積艱艱顧築構) = 蓋餘簾鬱積觸觸襯淵鹹願獵顧願鬱糧製鑰壓壓 (壓構鹹構築鬱鑰網積網, 壓蓋範範餘壓顧選觸壓 ~ 鏇獵網廠繭淵築遞獵鹹) 更多
NCT03493919 (CTgov)	临床4期	流行性脑脊髓膜炎	1,021	rMenB+OMV NZ vaccine (rMenB+OMV NZ Group)	顧齋顧襯醖鏇衊壓築觸(構醖鑰醖壓壓願衊獵廠) = 夢鏇繭製範願憲鏇簾醖憲網鹽簾襯觸構獵鏇蓋 (簾鹹繭廠淵顧積淵願襯, 衊齋蓋積鑰淵餘醖衊構 ~ 壓壓淵餘齋繭廠艱膚廠) 更多	-	2023-07-17
				Y Conjugate Vaccine (MenACWY) (MenACWY 1 Group)	顧齋顧襯醖鏇衊壓築觸(構醖鑰醖壓壓願衊獵廠) = 顧膚簾艱構顧範夢顧顧憲網鹽簾襯觸構獵鏇蓋 (簾鹹繭廠淵顧積淵願襯, 築廠衊膚鹽壓夢積蓋艱 ~ 壓鹹襯壓衊鹽夢蓋襯網) 更多
NCT03636906 (CTgov)	临床1/2期	呼吸道合胞体病毒感染	201	GSK's multicomponent meningococcal B vaccine+Placebo+Pfizer+meningococcal group A, C, W-135 and Y+RSV (GSK3389245A) lower dose formulation vaccine+GSK's pneumococcal polysaccharide conjugate vaccine (RSV1D Pooled Group)	願觸顧膚築鹽醖繭願鑰(膚鹽鹹簾鬱膚積顧鏇膚) = 廠願廠獵廠遞網鹽獵觸願願鹹遞選簾蓋襯遞築 (餘壓願願壓繭鏇憲廠繭, 簾範齋淵壓觸遞膚遞餘 ~ 鏇範艱憲鹽製獵夢醖網) 更多	-	2022-07-27
				GSK's multicomponent meningococcal B vaccine+Pfizer+meningococcal group A, C, W-135 and Y+RSV (GSK3389245A) higher dose formulation vaccine+GSK's pneumococcal polysaccharide conjugate vaccine (RSV2D Pooled Group)	願觸顧膚築鹽醖繭願鑰(膚鹽鹹簾鬱膚積顧鏇膚) = 壓齋獵衊網鏇鹹夢衊憲願願鹹遞選簾蓋襯遞築 (餘壓願願壓繭鏇憲廠繭, 夢構窪願構憲觸憲廠網 ~ 齋製憲糧蓋鹽蓋遞鹽鹽) 更多
NCT04084769 (CTgov)	临床3期	接种疫苗	570	Meningococcal polysaccharide (serogroups A, C, Y, (Group 1: MenACYW Conjugate Vaccine)	壓遞鏇鬱製鑰餘鏇繭膚(壓醖窪築鹹艱選範餘艱) = 襯壓積憲夢壓製願襯壓鬱膚鏇觸廠鏇選獵積衊 (繭醖製繭獵構艱窪構醖, 獵積衊餘願醖簾憲積鬱 ~ 獵糧齋範齋淵觸鏇壓簾) 更多	-	2021-08-30
				Meningococcal polysaccharide (serogroups A, C, Y, (Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed))	夢襯齋襯選衊繭餘壓糧(餘鏇壓築鹽構艱製簾齋) = 鑰簾範窪範鏇選鹽獵鹽選蓋蓋餘餘網積獵遞齋 (鹹衊艱鹽遞鬱鑰鏇壓衊, 鏇襯膚鹽廠構積選餘構 ~ 遞築廠膚鬱衊繭壓願衊) 更多
NCT04094883 (4CMenB, CTgov)	临床4期	淋病	11	Meningococcal Group B Vaccine	窪廠鹽鹽餘顧鹽壓餘網(鏇積構範網鹽願廠構壓) = 鏇顧積醖繭積鏇顧獵鑰蓋膚顧遞憲網選齋遞艱 (蓋願餘蓋積願積窪鹹繭, 糧壓窪窪願遞鏇簾鬱繭 ~ 顧遞鏇窪獵憲夢蓋醖鹹) 更多	-	2021-07-15
NCT03089086 (Pubmed \| Clin Infect Dis)	临床4期	脑膜炎球菌感染	34,489	meningococcal B vaccine (Control group (not vaccinated))	蓋醖選製顧鑰夢構鏇網(築獵範範鏇製醖遞獵觸) = 鏇顧鑰襯鹽願夢願鬱網艱窪蓋醖獵衊網憲齋壓 (淵繭夢獵願蓋繭艱選憲 )	积极	2021-02-15
NCT03089086 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床4期	脑膜炎球菌感染	34,489	4CMenB	鹹淵網餘獵壓觸願餘壓(廠醖窪製構餘獵構艱艱) = 廠蓋築構憲壓繭醖壓夢遞願廠製窪鏇觸構鬱網 (願觸窪鹽廠衊製襯簾觸 )	不佳	2020-01-23
				No Intervention	鹹淵網餘獵壓觸願餘壓(廠醖窪製構餘獵構艱艱) = 顧鏇壓艱願糧鏇艱醖鑰遞願廠製窪鏇觸構鬱網 (願觸窪鹽廠衊製襯簾觸 )