A Phase II Randomised, Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of the R21/Matrix-M1 Malaria Vaccine in Healthy African Women of Childbearing Potential in Mali

This will be a double-blind, individually randomised trial, to assess the safety, tolerability, immunogenicity, and protective efficacy of two and three doses of the R21/Matrix-M1 malaria vaccine or placebo given at 4 week intervals in healthy women of childbearing potential (WOCBP), who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.
Participants will be randomised in Year 1 into three groups in a 1:1:1 ratio:
* Arm 1 (n=110): will receive three doses of R21/Matrix-M1 malaria vaccine at months 0, 1 and 2.
* Arm 2 (n=110): will receive normal saline (placebo) at month 0 and two doses of R21/Matrix-M1 malaria vaccine at months 1 and 2.
* Arm 3 (n=110): will receive three of doses normal saline (placebo) at months 0, 1 and 2. In Year 2: Non-pregnant participants in arms 1 and 2 will be randomised in a 1:1 ratio to receive a booster dose of R21/Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season. Participants in the control group (arm 3) will receive normal saline (placebo).
Initial follow-up will be for two years after dose three, with an efficacy analysis at 6, 12, 18 and 24 months after dose 3.
Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period.
Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery (as well as their offspring) for safety and malaria infection

开始日期2025-03-19

申办/合作机构

University of Oxford

[+1]

NCT06068530

/ Recruiting临床4期IIT

A Cluster-randomised, Open-label Trial to Compare the Impact of Combined Mass Vaccine and Drug Administrations, Mass Drug Administration, Mass Vaccinations, or no Intervention on Plasmodium Falciparum Malaria Transmission

This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

开始日期2025-02-15

申办/合作机构

University of Oxford

NCT06507605

/ Not yet recruiting临床1期

Phase 1 Randomized, Double-blind Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in Healthy African Adults

This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.

开始日期2024-07-30

申办/合作机构

Serum Institute of India Pvt Ltd.

[+1]

100 项与 R21/Matrix-M 相关的临床结果

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100 项与 R21/Matrix-M 相关的转化医学

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100 项与 R21/Matrix-M 相关的专利（医药）

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项与 R21/Matrix-M 相关的文献（医药）

2025-03-01·Lancet Microbe

R21 in Matrix-M adjuvant in UK malaria-naive adult men and non-pregnant women aged 18–45 years: an open-label, partially blinded, phase 1–2a controlled human malaria infection study

Article

作者: Griffiths, Oliver ; Angus, Brian ; Lawrie, Alison M ; Ewer, Katie J ; Edwards, Nick J ; Mair, Catherine ; Brendish, Nathan ; Berrie, Eleanor ; Datoo, Mehreen S ; Angell-Manning, Philip ; Bellamy, Duncan ; Morter, Richard ; Minassian, Angela M ; Powlson, Jonathan ; Folegatti, Pedro M ; Venkatraman, Navin ; Faust, Saul N ; Hill, Adrian V S ; Silman, Daniel ; Blagborough, Andrew M ; Lopez, Fernando Ramos ; Baum, Jake ; Glenn, Greg ; Stockdale, Lisa ; Poulton, Ian ; Lewis, David J M ; Brod, Florian ; Collins, Katharine A ; Fries, Louis ; Roberts, Rachel ; Bowyer, Georgina

BACKGROUND:

R21 is a novel malaria vaccine, composed of a fusion protein of the malaria circumsporozoite protein and hepatitis B surface antigen. Following favourable safety and immunogenicity in a phase 1 study, we aimed to assess the efficacy of R21 administered with Matrix-M (R21/MM) against clinical malaria in adults from the UK who were malaria naive in a controlled human malaria infection study.

METHODS:

In this open-label, partially blinded, phase 1-2A controlled human malaria infection study undertaken in Oxford, Southampton, and London, UK, we tested five novel vaccination regimens of R21/MM. A standard three-dose regimen (groups 1 and 6) was compared with a reduced (fractional) third dose (groups 2 and 5) of R21/MM, concomitant administration with viral vectors ChAd63-MVA expressing ME-TRAP (group 3), and a two-dose R21/MM regimen (group 7). Controlled Human Malaria Infection (CHMI) was delivered by mosquito bite at Imperial College London, London, UK, 3-4 weeks after final vaccination (or 18 months after final vaccination for group 6) alongside unvaccinated controls (groups 4A and 4B). The primary outcome measures were to assess safety of the vaccines in healthy malaria-naive volunteers and the efficacy (occurrence of blood-stage malaria infection) of the different vaccine regimens compared with non-vaccinated controls after CHMI. The trial was registered with ClinicalTrials.gov (NCT02905019).

FINDINGS:

66 volunteers were enrolled with 59 undergoing subsequent CHMI. All vaccination schedules were well tolerated. The highest level of protection against CHMI was observed in participants receiving the standard three-dose regimen of R21/MM (group 1, nine of 11 volunteers protected) with protection maintained in three of five volunteers re-challenged by CHMI 7·5 months later. Protection against malaria was also seen in group 2, group 3, and group 5 compared with unvaccinated control participants. Total IgG antibody responses to the NANP repeat region of circumsporozoite protein peaked after the third dose of R21/MM in all volunteers and were well maintained to 90 days after challenge. Reducing the third dose did not affect protection or antibody concentrations.

INTERPRETATION:

Our study shows that R21/MM elicits high-level efficacy against clinical malaria in a controlled human infection model of malaria in adults who are malaria naive. These data supported the evaluation of R21/MM in field efficacy trials in the target population of young children in malaria-endemic areas.

FUNDING:

EU Horizon 2020, the UK Medical Research Council, the European Commission, the UK National Institute of Health Research, the Imperial NIHR Clinical Research Facility, the Oxford NIHR Biomedical Research Centre, and the Wellcome Trust.

2025-03-01·NATURE REVIEWS MICROBIOLOGY

Towards next-generation treatment options to combat Plasmodium falciparum malaria

Review

作者: Fidock, David A. ; Okombo, John ; Fidock, David A

Malaria, which is caused by infection of red blood cells with Plasmodium parasites, can be fatal in non-immune individuals if left untreated. The recent approval of the pre-erythrocytic vaccines RTS, S/AS01 and R21/Matrix-M has ushered in hope of substantial reductions in mortality rates, especially when combined with other existing interventions. However, the efficacy of these vaccines is partial, and chemotherapy remains central to malaria treatment and control. For many antimalarial drugs, clinical efficacy has been compromised by the emergence of drug-resistant Plasmodium falciparum strains. Therefore, there is an urgent need for new antimalarial medicines to complement the existing first-line artemisinin-based combination therapies. In this Review, we discuss various opportunities to expand the present malaria treatment space, appraise the current antimalarial drug development pipeline and highlight examples of promising targets. We also discuss other approaches to circumvent antimalarial resistance and how potency against drug-resistant parasites could be retained.

2025-03-01·Lancet Microbe

Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials

Article

作者: Imoukhuede, Egeruan B ; Hill, Adrian V S ; Lövgren-Bengtsson, Karin ; Stockdale, Lisa K ; Sirima, Sodiomon B ; Fries, Louis F ; Dickinson-Craig, Emma ; Green, Nicola ; Bougouma, Edith C ; Nébié, Issa ; Collins, Katharine A ; Poulton, Ian ; Lewis, David J M ; Viebig, Nicola K ; Powlson, Jonathan ; Lawrie, Alison ; Roberts, Rachel ; Ouedraogo, Alphonse ; Angus, Brian ; Diarra, Amidou ; Venkatraman, Navin ; Berrie, Eleanor ; Silman, Daniel ; Baker, Megan ; Wright, Daniel ; Coulibaly, Sam ; Ewer, Katie J ; Glenn, Greg ; Reimer, Jenny M ; Bliss, Carly M ; Moyle, Sarah ; Mukhopadhyay, Ekta ; Gilbert, Sarah C ; Brod, Florian ; Morter, Richard ; Bellamy, Duncan G ; Jamieson, Sophie ; Bowyer, Georgina ; Tiono, Alfred B ; Datoo, Mehreen S ; Folegatti, Pedro

BACKGROUND:

Malaria remains a substantial public health burden among young children in sub-Saharan Africa and a highly efficacious vaccine eliciting a durable immune response would be a useful tool for controlling malaria. R21 is a malaria vaccine comprising nanoparticles, formed from a circumsporozoite protein and hepatitis B surface antigen (HBsAg) fusion protein, without any unfused HBsAg, and is administered with the saponin-based Matrix-M adjuvant. This study aimed to assess the safety and immunogenicity of the malaria vaccine candidate, R21, administered with or without adjuvant Matrix-M in adults naïve to malaria infection and in healthy adults from malaria endemic areas.

METHODS:

In this Article we report two phase 1, first-in-human trials. The first trial was a phase 1a open-label study in the UK evaluating the safety and immunogenicity of R21 administered either alone, or with 50 μg of Matrix-M. The second trial was a phase 1b randomised controlled trial in Burkina Faso. Adults had to be aged 18-50 years for enrolment in the phase 1a trial, and 18-45 years in the phase 1b trial. The phase 1a trial doses were 2 μg, 10 μg, and 50 μg R21/Matrix-M, and 50 μg R21 only. The phase 1b trial doses were 10 μg R21/Matrix-M and saline placebo. Matrix-M was always dosed at 50 μg. Phase 1b implemented block randomisation by randomisation into study groups by an independent statistician based at the University of Oxford using a randomisation code list with allocation concealment using opaque sealed envelopes. The primary objective of the phase 1a trial was to assess the safety and tolerability of R21 with and without Matrix-M. The primary objective of the phase 1b trial was to assess the safety and tolerability of R21 with Matrix-M. Both trials are registered with ClinicalTrials.gov, NCT02572388 for phase 1a and NCT02925403 for phase 1b, and are completed.

FINDINGS:

Between Oct 1, 2015, and Jan 3, 2017, 31 individuals were enrolled in the phase 1a study. Six individuals were assigned to receive 2 μg R21/Matrix-M, 11 to 10 μg R21/Matrix-M, ten to 50 μg R21/Matrix-M, and four to 50 μg R21 only. Between Aug 26, 2016, and Sept 28, 2017, 13 individuals were enrolled in the phase 1b study. Eight individuals were assigned to receive 10 μg R21/Matrix-M, and five to placebo. Vaccinations were well tolerated, and most local and systemic adverse events were mild. There were no serious adverse events deemed related to vaccination. Two serious adverse events occurred. The first in the 10 μg R21/Matrix-M group was worsening of previously undisclosed or undiagnosed palindromic rheumatism and was deemed unlikely to be related to vaccination and the second in the 2 μg R21/Matrix-M was hospital admission for an unplanned excision of a pre-existing Bartholin's cyst, also unrelated to vaccination. In the phase 1a study, a total of 21 adverse events were recorded in the 2 μg R21/Matrix-M group, 103 in the 10 μg R21/Matrix-M group, 94 in the 50 μg R21/Matrix-M group, and 21 in the 50 μg R21 alone group. In the phase 1b study, twelve adverse events were recorded in the 10 μg R21/Matrix-M group and 0 in the placebo group.

INTERPRETATION:

R21 with Matrix-M adjuvant has an acceptable safety profile. These data have formed the basis for efficacy testing of this vaccine.

FUNDING:

The European Commission Framework 7 and The European & Developing Countries Clinical Trials Partnership.

项与 R21/Matrix-M 相关的新闻（医药）

2025-02-18

·药物分子设计

新药开发有多难？DeepSeek也感叹这是一场伦理与生存的双重困境

第一性原理计算解决50年悬而未决难题：半导体中铜为何扩散更快？ Ab initio及第一性原理入门参考书介绍《海贼王》告诉你，做科研为什么不能闭门造车…… 来自公众号：智药邦本文以传播知识为目的，如有侵权请后台联系我们，我们将在第一时间删除。 DeepSeek｜撰文李华（福建中医药大学药学院院长）｜编辑在人类对抗疾病的漫长历史中，药物研发始终是科学与命运博弈的最前线。从神农尝百草到现代人工智能辅助药物设计，从青霉素的偶然发现到新冠mRNA疫苗的快速开发，每一次突破都伴随着无数失败，每一个成功案例背后都矗立着数十年积累的科研丰碑。药物发现之所以被称为生物医学的永恒挑战，不仅因其科学探索的艰深本质，更因其始终处于技术创新、伦理困境与经济博弈的复杂漩涡之中。一、科学迷宫的永恒突围现代药物研发犹如在原子尺度解构生命密码。一个候选分子需要跨越靶点验证、先导化合物优化、临床前研究、三期临床试验等十余个关键节点，每个环节的失败率都超过90%。阿尔茨海默病领域数十年间超过200个III期临床试验失败，抗癌药物平均研发成本达26亿美元，这些数字揭示着生命系统的复杂本质：当科学家通过CRISPR敲除某个致病基因时，可能同时激活了三个未知的补偿通路；当抗体药物精准结合靶点时，微小的构象变化就可能导致完全失效。更严峻的是，病原体与肿瘤细胞在进化压力下的持续突变，使得药物研发成为永远落后半步的追赶游戏。二、经济理性的冰冷方程式在制药公司财务报表上，药物研发是道残酷的算术题：需要10年周期、20亿美元投入的项目，必须预测10年后某个适应症的市场规模。这种经济理性导致"10/90鸿沟"持续存在——全球90%的研发投入集中于只影响10%人口的富贵病。被忽视的热带病每年导致50万人死亡，但2019年相关研发投入仅占全球医药研发总支出的0.12%。当第三世界患者死于廉价可防疾病时，大型药企正为研发回报率跌破1.8%的行业红线而焦虑。这种价值悖论将药物发现拖入伦理与生存的双重困境。三、技术革命的双刃剑人工智能与类器官技术的突破带来了新的曙光。AlphaFold2破解了2亿个蛋白质结构，器官芯片让临床前预测准确性提升40%，但技术乐观主义往往遮蔽了更深层的挑战。 AI模型需要30亿个数据点训练，而人类对细胞信号通路的认知尚不足50%；基因疗法单剂定价百万美元，将医疗公平推向更尖锐的冲突。当CAR-T细胞在患者体内开启"细胞战争"时，科学共同体不得不直面技术奇点带来的监管真空与伦理悬崖。四、文明进程的韧性测试　　药物发现史本质是人类文明的韧性测试。1918年大流感催生了现代疫苗技术，艾滋病危机重塑了药物审批体系，新冠疫情证明了mRNA平台的战略价值。当前，全球首款疟疾疫苗R21的诞生、渐冻症患者通过脑机接口推动药物研发的故事，预示着开放科学与患者社群正在重构研发范式。当生物银行储存的500万份样本遇见量子计算模拟的分子动力学，当发展中国家通过专利池获得新冠治疗技术时，我们看到了挑战背后孕育的文明跃迁可能。站在合成生物学与人工智能的交汇点，药物发现仍将长期处于"有限认知与无限可能"的张力之中。这场永恒的挑战终将演变为对人类智慧、良知与协作能力的持续考验——唯有保持对自然规律的敬畏、对生命价值的坚守，方能在攻克疾病的长征中续写文明的新篇。毕竟，当第一个尼安德特人用柳树皮减轻疼痛时，就注定了这场跨越十万年的医学远征永无终点。 Per aspera ad astra.循此苦旅，以达星辰！注：本文始发于“Acta Materia Medica”。

信使RNA疫苗细胞疗法基因疗法临床3期

2025-01-25

·药时空

非洲疟疾疫苗引入：进展与挑战

疟疾是非洲地区长期面临的重大公共卫生挑战，占全球疟疾病例的94%和相关死亡的95%。尽管自2000年以来全球疟疾死亡率显著下降，但2024年世界疟疾报告揭示了一个令人担忧的趋势：全球疟疾发病率在2023年达到每1000人58.6例，远未达到世界卫生组织全球技术战略目标（21.3例/1000人）。在这种背景下，2024年非洲疟疾疫苗（RTS,S/AS01和R21/Matrix-M）的引入成为抗击疟疾的重要里程碑。作为一名疫苗专家，我有幸见证了这一历史时刻，并对非洲疟疾疫苗引入的进展与挑战进行深入分析。一、非洲疟疾疫苗引入的进展（一）快速引入与政治承诺 2024年，非洲14个国家（包括喀麦隆、布基纳法索、贝宁、塞拉利昂等）引入了疟疾疫苗，加上之前试点的加纳、肯尼亚和马拉维，疫苗引入范围迅速扩大。超过812万剂疫苗被分发，截至2024年12月初，已有超过70万名儿童在10个国家接种了首剂疫苗。喀麦隆于2024年1月22日率先启动RTS,S/AS01疫苗接种，尼日利亚于12月2日引入R21/Matrix-M疫苗，标志着非洲疟疾疫苗引入的全面铺开。（二）创新策略与成功案例各国在疫苗引入过程中展现了强大的适应性与创新能力。加纳同时引入两种疫苗（RTS,S/AS01和R21），成为全球首个采用双疫苗策略的国家，为其他国家提供了宝贵经验。乍得将RTS,S/AS01疫苗与其他新疫苗（如肺炎球菌结合疫苗和轮状病毒疫苗）整合引入，优化了疫苗接种流程。布基纳法索在安全形势严峻的地区实现了89%的首剂接种覆盖率，证明即使在脆弱环境中，通过适当的策略也能实现高疫苗覆盖率。（三）高层政治倡议与合作 2024年，非洲各国通过多项高层政治倡议加强了疟疾防控的合作与协调。雅温得宣言（2024年3月）、尼日利亚疟疾消除部长级会议（2024年5月）和阿比让宣言（2024年7月）等，都强调了协调干预、降低死亡率和可持续免疫融资的重要性。这些倡议为疟疾疫苗的引入提供了有力的政治支持。二、非洲疟疾疫苗引入的挑战（一）资金可持续性疟疾疫苗引入的资金需求巨大，尼日利亚预计到2027年疫苗相关支出将达到2.436亿美元，且运营成本每年预计增长8.9%。疫苗价格差异显著，每剂价格在3.90至10美元之间，导致不同国家在实施过程中出现不平等。此外，一些国家存在支付疫苗分摊费用（co-financing）违约的情况，给疫苗引入带来不确定性。尽管Gavi疫苗联盟是重要的合作伙伴，但过度依赖外部资金也凸显了项目的脆弱性。（二）疫苗接种覆盖率差异在报告的10个国家中，疟疾疫苗接种覆盖率存在显著差异，首剂接种覆盖率中位数为52.5%（四分位间距20.0-66.0%）。在报告完整三剂数据的6个国家中，第三剂接种覆盖率降至17.0%（四分位间距6.0-29.0%）。尽管布基纳法索在第三剂接种时保持了70.0%的覆盖率，但其他国家如尼日尔的覆盖率从第一剂的65.0%降至第二剂的9.0%，显示出接种过程中的显著流失。（三）监管效率低下非洲约67.3%的国家监管机构审批流程漫长，平均审批时间为203天，远超世界卫生组织推荐的90天审查期。83%的国家监管机构处于成熟度2级（部分执行基本监管职能），监管基础设施薄弱。与制造商的协调不一致进一步加剧了这些瓶颈，导致尼日尔和布隆迪等国的疫苗引入延迟。（四）运营中断受冲突影响地区的安全挑战和同时发生的其他疫情（如猴痘危机）对本已脆弱的卫生系统造成巨大压力。利比里亚在引入疟疾疫苗时恰逢应对脊髓灰质炎疫情，需要复杂的资源重新分配。苏丹在冲突中努力覆盖流离失所人群，凸显了公共卫生干预与人道主义危机之间的复杂关系。三、应对策略与未来展望（一）可持续融资为确保疟疾疫苗引入的可持续性，必须优先考虑可持续融资。疫苗引入的运营成本可能占疫苗价格的25%至85%，因此需要将疫苗引入与全面财务计划相结合。非洲疫苗生产加速器的8亿欧元投资为通过集中采购和增加本地生产降低成本提供了机会。加纳转向更具成本效益的R21疫苗是一个财务适应性的实际模型。（二）创新的“最后一公里”交付模式创新的交付模式对于提高疫苗接种效率至关重要。加纳使用Zipline无人机将交付效率提高了40%；乍得通过利用职业健康工作者优化社区层面的疫苗交付；喀麦隆的“大追赶”运动在9个月内将首剂接种覆盖率提高了三倍。利用数字健康工具和文化定制的社区参与策略可以进一步增强疫苗接种的依从性和剂量方案的接受度。（三）监管协调通过世界卫生组织非洲疫苗监管论坛等机制简化审批流程，可以显著减少批准延迟。制造商应积极与各国的具体要求进行沟通协调。对药物警戒和能力建设的投资将确保疫苗引入的及时性和安全性。（四）整合与优化疟疾疫苗的引入必须与现有的疟疾控制措施相结合，以最大化其潜力。随着布隆迪、几内亚、几内亚比绍等国准备在2025年进行疟疾疫苗的次国家引入，以及13个国家准备扩大疫苗规模，确保四剂接种方案的持续实施和优化干预措施的组合至关重要。世界卫生组织非洲区域办事处重申其对成员国的支持承诺，通过加速疟疾疫苗引入和推广平台，继续提供强有力的技术支持，促进知识共享和协作。四、结论 2024年非洲疟疾疫苗的引入证明了政治意愿和合作可以推动变革性的健康干预措施，但仍有显著的障碍需要克服。撒哈拉以南非洲地区平均将国内生产总值的5%分配给卫生，远低于阿布贾目标的15%，超过40%的Gavi符合条件的国家面临债务困境，这使得政府在维持Gavi 85/15共同融资模式方面面临巨大压力。此外，人口增长率为2.36%，单个儿童接种疫苗的成本（2019年估计为25-37美元）也在上升。劳动力短缺进一步阻碍了进展，例如中非共和国每10000人中只有5.5名熟练卫生工作者，远低于世界卫生组织推荐的44.5名的阈值。解决这些障碍需要通过创新融资、债务减免和将疟疾疫苗整合到现有控制措施中来重新调整融资模式。随着疟疾疫苗引入的持续推进，非洲在抗击疟疾的道路上迈出了重要一步。然而，要实现疟疾的全面控制和消除，仍需各国政府、国际组织和社区的共同努力。通过持续的资金支持、优化的交付策略和有效的监管协调，疟疾疫苗有望成为非洲抗击疟疾的有力武器，为非洲人民的健康和福祉带来持久的改变。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗

2025-01-10

·PRNewswire

Primrose Bio to Collaborate with Serum Institute of India to Develop a Novel Multi-Antigen Vaccine

SAN DIEGO, Jan. 10, 2025 /PRNewswire/ -- Primrose Bio, Inc. ("Primrose"), a company with proprietary manufacturing technologies for human therapeutics, and Serum Institute of India Pvt. Ltd. ("SIIPL"), the world's largest vaccine manufacturer, today announced a collaboration to develop a novel multi-antigen vaccine for infections that affect millions of people globally. Both companies will contribute towards the design of the vaccine with Primrose fully responsible for developing manufacturing strains using its Pfenex Expression Technology and SIIPL responsible for further development and commercialization. "We are eager to strengthen our long-standing relationship with Primrose to develop a new vaccine with the potential to save millions of lives globally," said Dr. Umesh Shaligram, Executive Director of Serum Institute of India. "This ambitious program faces many technical challenges, which become more difficult when aiming for global affordability. We believe the robustness of the Pfenex Expression Technology will enable us to solve these technical challenges at a global scale." "We are delighted to deepen our long-standing relationship with SIIPL, a global leader in vaccine innovation," said Helge Zieler, PhD, CEO of Primrose Bio. "This commitment demonstrates the versatility and transformative potential of the Pfenex Expression Technology to address critical vaccine antigen manufacturing and global health needs." SIIPL will collaborate for the development of the manufacturing strains and is responsible for future preclinical and clinical development as well as commercialization. About Primrose Bio, Inc. Primrose Bio is focused on developing and commercializing its integrated end-to-end technology platform for solving complex drug manufacturing and design challenges. Primrose major offerings include Pfenex Expression Technology®: a proprietary production system with up to 20x higher yields, unparalleled success in making complex proteins, and currently used in six approved products; Prima RNApols™: improved enzymes for mRNA manufacturing; and PeliCRM197®: a commercially validated CRM197 carrier protein used for conjugate vaccines. Several of the world's leading pharmaceutical companies use Primrose's technologies, including Merck, Jazz Pharmaceuticals, Alvogen, Serum Institute of India, Arcellx, Arcturus and others. For more information, please visit . About Serum Institute of India, Pvt. Ltd. Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years. Founded in 1966, SII's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second malaria vaccine to be authorized for use in children in malaria-endemic regions. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide. To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. For more information, please visit . SOURCE Primrose Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗上市批准信使RNA

100 项与 R21/Matrix-M 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16369

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
疟疾	加纳	University of Oxford	2023-04-13
疟疾	加纳	Serum Institute of India Pvt Ltd.	2023-04-13

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
恶性疟	临床2期	肯尼亚	Kenya Medical Research Institute	2019-04-30

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临床结果

适应症

分期

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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


NCT04704830 (phase 3 trial, Pubmed \| Lancet)	临床3期	疟疾	5,477	R21/Matrix-M vaccine	齋願餘齋積繭襯餘淵壓(繭願鬱觸醖願範壓膚窪) = 積衊選簾夢壓憲願蓋襯鹹襯製積鹽廠蓋製製繭 (觸襯鏇鑰積艱簾願餘淵, 71 ~ 79) 更多	积极	2024-02-01
				Control vaccine (licensed rabies vaccine [Abhayrab])	齋願餘齋積繭襯餘淵壓(繭願鬱觸醖願範壓膚窪) = 積築膚築醖鑰簾積餘夢鹹襯製積鹽廠蓋製製繭 (觸襯鏇鑰積艱簾願餘淵, 61 ~ 74) 更多
NCT02572388 (CTgov)	临床1期	疟疾	31	Matrix-M1+R21 (Group 1)	鹽獵製糧鹽夢範築艱鏇 = 淵艱膚鏇觸築窪窪築製願繭廠蓋鏇糧製鹹衊選 (鬱淵鏇積艱憲網積艱網, 構願醖顧蓋蓋憲願憲夢 ~ 蓋襯醖廠觸製鑰觸構襯) 更多	-	2019-11-12
				R21 (Group 2)	鹽獵製糧鹽夢範築艱鏇 = 廠積糧廠構餘壓積簾壓願繭廠蓋鏇糧製鹹衊選 (鬱淵鏇積艱憲網積艱網, 繭構糧網遞齋範積獵淵 ~ 衊選壓襯願衊鏇壓夢窪) 更多
NCT02925403 (CTgov)	临床1/2期	疟疾	13	R21/Matrix-M1 (Group 1)	顧蓋衊顧鏇鏇築壓壓鹽 = 遞範淵觸鏇廠顧餘獵鬱鏇糧衊糧製齋襯願遞艱 (築鹹製餘鑰憲淵襯觸糧, 淵齋餘願憲鑰蓋淵壓範 ~ 鏇齋選簾構鏇顧願簾鑰) 更多	-	2019-11-06
				R21/Matrix-M1 (Group 2)	顧蓋衊顧鏇鏇築壓壓鹽 = 窪鹹網顧鬱鬱廠蓋構窪鏇糧衊糧製齋襯願遞艱 (築鹹製餘鑰憲淵襯觸糧, 繭觸窪襯衊廠壓齋壓顧 ~ 廠積鏇夢簾艱餘艱蓋構) 更多