A Phase II Clinical Study to Assess the Safety, Immunogenicity, and Efficacy of Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvRII/Matrix-M in Healthy Thai Adults Living in Thailand

This project is the third part of a 5-year research program entitled "Malaria Infection Studies in Thailand (MIST)" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII/Matrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII/Matrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII/Matrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form.
This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A

开始日期2025-12-01

申办/合作机构

University of Oxford

[+1]

NCT05978037

/ Active, not recruiting临床1/2期IIT

An Open Label Phase I/IIa Clinical Trial to Assess the Safety, Immunogenicity and Efficacy of the Malaria Vaccine Candidate RH5.2-virus-like Particle (VLP) in Matrix-MTM, and to Compare the Safety and Immunogenicity of the Malaria Vaccine Candidates RH5.2-VLP in Matrix-MTM and RH5.1 Soluble Protein in Matrix-MTM Used in Various Regimens

Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. There is a great need for a safe, effective malaria vaccine and the team at University of Oxford is trying to make vaccine(s) which can prevent serious illness and death.
This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness. This is done using a 'blood-stage challenge model'. This is when volunteers are infected with malaria parasites using malaria-infected red blood cells.
The vaccine we are testing in this part of the study is called "RH5.2-VLP". It is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination. RH5.2-VLP is being tested for the first time in humans in this trial. The Matrix-M adjuvant has been given to tens of thousands of people, with no major concerns, such as illness.
The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
1. The safety of the vaccine in healthy participants.
2. The response of the human immune system to the vaccine.
3. The ability of the vaccine to prevent malaria illness (Group 2 only). We will do this by giving healthy adult participants (aged 18-45) three of the vaccines and/or expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital in Oxford. We will then do blood tests and collect information about any symptoms that occur after vaccination. There will be 19 to 54 visits, lasting between 3 months to 2 years and 2 months.

开始日期2023-08-18

申办/合作机构

University of Oxford

NCT06141057

/ Active, not recruiting临床1期IIT

Phase I Clinical Trial to Assess the Safety and Immunogenicity of the Malaria Vaccine Candidate RH5.1 Soluble Protein in Matrix-MTM Using Two Dosing Regimens

Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine.
This study is being done to evaluate an experimental malaria vaccine for its safety and also look at the body's immune response to the vaccine.
The vaccine tested in this study is called and "RH5.1". This is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination.
The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
1. The safety of the vaccines in healthy participants.
2. The response of the human immune system to the vaccines.
This will be achieved by giving participants three doses of the RH5.1 vaccines at two different dose levels (10 micrograms and 50 micrograms). One group will have 3 doses of 10 micrograms given at 0, 1 and 6 months whilst the other will receive 2 doses of 50 micrograms (at 1 and 2 months) followed by a 10 microgram dose at 6 months- known as a 'delayed fractional dose'. Blood tests and information about any symptoms will be performed/collected that occur after vaccination.
Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. Current prediction is that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.

开始日期2023-06-06

申办/合作机构

University of Oxford

100 项与 RH5.1 相关的临床结果

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100 项与 RH5.1 相关的转化医学

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100 项与 RH5.1 相关的专利（医药）

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2,417

项与 RH5.1 相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

PfCSP-ferritin nanoparticle malaria vaccine antigen formulated with aluminum-salt and CpG 1018® adjuvants: Preformulation characterization, antigen-adjuvant interactions, and mouse immunogenicity studies

Article

作者: Julien, Jean-Philippe ; Hickey, John M. ; Doering, Jennifer ; Costa, Giulia ; Sharma, Nitya ; Volkin, David B. ; Wizel, Benjamin ; Joshi, Sangeeta B. ; Prieto, Katherine ; Fairlamb, Max ; Levashina, Elena A. ; Mantis, Nicholas J. ; Adewunmi, Yetunde

Circumsporozite protein (CSP), the most abundant surface protein in parasitic Plasmodium falciparum (Pf) sporozoite and an attractive target for malaria vaccine design, has been shown to induce protective humoral response in humans. In this work, we characterized and formulated a promising recombinant PfCSP immunogen (155) candidate consisting of two PfCSP epitopes (i.e. junction, NANP repeat) fused to H. pylori apoferritin forming a 24-mer nanoparticle. In addition, two N-linked glycans were engineered to mitigate possible anti-apoferritin immune responses, and a universal T-cell epitope was included to further enhance immunogenicity. Physicochemical characterization of the 155 antigen was performed including primary structure, post-translational modifications, conformational stability, and particle size. A competitive ELISA was developed to assess antigen binding to a PfCSP-specific mAb. The in vitro antigenicity of the 155 antigen was measured upon formulation with adjuvants, including aluminum-salts (i.e. Alhydrogel^TM, Adju-Phos^TM) and the TLR-9 agonist CpG 1018®, when freshly combined and after storage at different temperatures over 3 months. The in vivo immunological impact of various adjuvanted formulations of the 155 antigen was investigated in mice. The results support the formulation of 155 with Alhydrogel^TM + CpG 1018® adjuvants as a promising recombinant malaria vaccine candidate from both a pharmaceutical and immunological perspective.

2025-06-01·GENE

Population genetic structure of the fibrinogen-related protein 1 (FREP1) in Iranian isolates of Anopheles stephensi as a promising mosquito-based malaria vaccine candidate

Article

作者: Mehrizi, Akram Abouie ; Pirahmadi, Sakineh ; Raz, Abbasali ; Kheirkhah, Omolbani

BACKGROUND:

Transmission Blocking Vaccines (TBVs) are critical for malaria eradication as they aim to interrupt the transmission cycle of Plasmodium parasites. However, the development of effective TBVs is challenged by the antigenic diversity of potential vaccine targets. This study investigates the fibrinogen-related protein 1 (frep1) gene, a promising candidate for TBVs, focusing on the genetic diversity of the frep1 gene and immunogenic potential in Anopheles stephensi from southern Iran.

METHODS:

Analysis of 30 An. stephensi isolates collected from three malaria-endemic cities was carried out using molecular amplification, sequencing, and bioinformatics tools. The haplotype and nucleotide diversity were assessed using the DnaSP, while predicted linear B-cell epitopes were evaluated through the ABCpred. Additionally, conformational epitopes were identified via DiscoTope analysis and visualized using the PyMOL. Furthermore, MHC II-peptide interactions were examined to evaluate the potential for effective immune responses.

RESULTS:

Seven distinct haplotypes of the frep1 domain were identified, with synonymous nucleotide variations indicating high genetic conservation. This conservation was complemented by the identification of 16 linear B-cell epitopes with high immunogenic scores (0.80-0.97). Conformational epitopes, prominently located at the N-terminus and C-terminus, were consistent across isolates. MHC II-binding analysis revealed peptides with strong affinities to prevalent HLA alleles in Iran, suggesting effective antigen presentation.

CONCLUSION:

FREP1 demonstrates purifying selection, low genetic diversity and high immunogenic potential, highlighting the suitability of the protein as a TBV candidate. The presence of conserved epitopes and strong MHC II interactions supports the potential of this protein for inducing robust immune responses. However, regional haplotype diversity suggests that vaccine strategies may need to account for local variability. These findings underscore the promise of FREP1 for TBV development and emphasize the need for further validation in vivo.

2025-05-01·VACCINE

Immunogenicity and efficacy in mice of two adjuvant formulations based on the C -and N-terminus of merozoite surface protein 1 of Plasmodium yoelii

Article

作者: Hong, Hyelee ; Park, Hyun ; Yeo, Seon-Ju ; Nguyen, Minh-Ngoc ; Eom, Tae Hui ; Yun, Su-Yeon ; Bae, Gum-Ju ; Hoang, Vui Thi

The carboxyl-terminal fragment of MSP-1 is a potential malaria vaccine candidate, but its limited immunogenicity in humans has slowed clinical progress, needing the optimization of formulation of adjuvant and construct. In this study, the N- and C-terminal fragments of the PyMSP-1 (PyMSP-1 N and PyMSP-1C) were immunized to mice with either incomplete Freund's adjuvant (IFA) plus CpG ODN 1826 or Aluminum salts (Alum) plus CpG, followed by a challenge with Plasmodium yoelii 17XNL to investigate vaccine efficacy. Humoral response and antigen-specific T-cell-derived IFN-γ cytokines were analyzed to compare both fragments. After challenge infection, all mice immunized by PyMSP-1C in IFA plus CpG ODN survived with low-grade parasitemia, while 50 % of mice immunized with PyMSP-1 N in Alum plus CpG ODN died with high levels of parasitemia. Co-immunized with both fragments prevented parasitemia entirely, with IFA plus CpG adjuvants proving more suitable than Alum plus CpG. Both fragments elicited a comparable humoral response when they were formulated with IFA plus CpG ODN but PyMSP-1 N formulated with Alum plus CpG ODN significantly decreased the antigen-specific IgG level. While both IgG1 and IgG2c levels were comparable in two fragments formulated by IFA plus CpG ODN, it was efficient to induce the level of IgG2c of PyMSP-1 N fragment (P < 0.0001). Likewise, IFN-γ from both CD8⁺ and CD4⁺ T-cells was significantly lower by PyMSP-1 N than PyMSP-1C formulated in IFA plus CpG ODN (P < 0.0001). In conclusion, the N-terminal fragment of PyMSP-1 protected mice although it showed lower humoral and cellular immune response compared to C-terminal of MSP-1 in IFA plus CpG. The antibody level of PyMSP-1 N was comparable to that of PyMSP-1C when it was formulated with IFA plus CpG.

项与 RH5.1 相关的新闻（医药）

2025-01-02

·牛津大学OxfordUniversity

牛津大学科技创新公司《2024年科技创新影响报告》：展示一年来变革性研究成果

牛津大学科技创新公司（Oxford University Innovation, OUI），作为牛津大学的技术转移办公室，发布了其2024年度报告《塑造未来：牛津大学科技创新影响报告》。在过去的12个月里，牛津大学科技创新公司筹集了数百万英镑的资金，用于资助创新研究和风险投资，申请了数十项新专利，并创建了超过15家新公司。 Oxford University Innovation (OUI), the technology transfer office of the University of Oxford, has launched its 2024 report Shaping the Future: Oxford’s Innovation Impact. Over the past 12 months, OUI raised millions of pounds to fund innovative research and venture creation, filed scores of new patents, and created more than 15 new companies. Swipe left for English 这份影响报告阐述了牛津大学对成立尖端衍生公司的支持，以及这些公司为牛津大学创造了数百万英镑回报，用以资助未来创新和研究。该报告是在牛津创新协会为学术创始人和领导者、风险资本投资者、行业和生态系统合作伙伴举办的活动上公布的。根据报告的关键数据显示，在2023年8月至2024年7月期间，OUI及其合作伙伴实现以下成果: 筹集了1950万英镑的种子基金；为牛津大学的衍生公司募集了8.72亿英镑的投资；创建了15家新公司，其中包括10家衍生公司、2家社会企业和3家初创公司；申请了93项新专利；从健康科技到清洁能源，达成了1239项许可交易。过去12个月的重要里程碑: MatchBio的创立：2024年1月，牛津大学衍生公司MatchBio获得450万英镑投资，专注于通过增强T细胞疗法推动免疫治疗的革新，抗击癌症；与生物医药公司Apollo Therapeutics的许可协议：该协议加速了牛津大学生物医学研究的商业化，推动新疗法的快速开发；疟疾疫苗的首次交付：OUI与印度血清研究所（Serum Institute of India）达成许可协议，促成R21/Matrix-M疟疾疫苗在非洲的首次交付，进一步推动公共卫生事业； Onfido的成功出售：2024年4月，学生创办的Onfido公司被全球安防公司Entrust Corp收购，成为牛津大学学生创业项目中回报最高的一次。Onfido利用人工智能进行身份验证，并提供关键的欺诈检测信号，过去一年帮助全球客户避免了39亿美元的欺诈损失；三星电子收购Oxford Semantic Technologies：这家牛津衍生企业专注于知识图谱与推理技术，其技术被三星电子收购。报告还显示，女性在OUI商业化活动中发挥着越来越重要的作用。参与OUI商业化活动的女性比例从2015-16年的27.8%增至2022-23年的33.7%。参与商业化项目的所有女性或男女混合团队从29.8%增加到39.5%。 The impact report sets out OUI’s support to form cutting edge spinouts and the return of millions of pounds to the University of Oxford to fund future innovation and research. The report was unveiled at an Oxford Innovation Society (OIS) event for academic founders and leaders, venture capital investors, industry and ecosystem partners. According to OUI’s preliminary output metrics, between August (2023) and July (2024), OUI and their partners: Raised £19.5m in seed funding Raised £872m in investment for Oxford’s companies Created 15 new companies, including 10 spinouts, 2 social ventures, and 3 start-ups Filed 93 new patents Struck 1,239 licensing deals from health tech to clean energy. Key achievements over the past 12 months include: The launch of Oxford University spinout MatchBio in January 2024 with a £4.5m investment. The company is working to revolutionise immunotherapy to fight cancer, by enhancing T Cell-based therapies. A new licensing agreement between Oxford University and biopharmaceutical company Apollo Therapeutics to accelerate the commercialisation of Oxford’s biomedical research by developing new therapies at pace The first deliveries of Oxford’s R21 / Matrix-M malaria vaccine in Africa, following a licensing deal OUI negotiated with the Serum Institute of India The purchase of student-led start-up Onfido by global security company Entrust Corp in April 2024. This represents the largest ever student-led company return on investment for the University of Oxford. Onfido uses artificial intelligence to verify customer identities, as well as providing vital fraud detection signals. Over the past year, Onfido has helped prevent $3.9bn in fraud losses for its global client base Samsung Electronics’ acquisition of Oxford Semantic Technologies, a spinout which specialised in cutting-edge knowledge graph and reasoning technology The report also reveals the growing role women are playing in OUI’s commercialisation activities. The share of unique female individuals involved in OUI commercialisation activities rose from 27.8% in 2015-16 to 33.7% in 2022-23. All female or mixed-sex teams involved in commercialisation projects increased from 29.8% to 39.5%. Swipe left for English OUI首席执行官玛丽·吉布斯博士（Dr Mairi Gibbs）说：“牛津大学科技创新公司始终致力于将前沿研究转化为现实世界的解决方案，以应对我们这个时代前所未有的挑战和机遇。” "我们的目标是支持牛津大学的创新者，确保他们的想法能够对经济、社会和环境产生持久的影响。我们的未来将由学术界、产业界和社会各界之间的密切合作来塑造——我们很高兴能在牛津大学引领这一未来的建设。" OUI执行主席尼古拉·布莱克伍德女男爵（Baroness Nicola Blackwood）说：“随着世界面临越来越复杂的挑战，我们的创新速度和规模比以往任何时候都更为重要。在过去的一年里，牛津大学科技创新公司在将突破性研究转化为实际经济和社会效益方面继续发挥着关键作用，巩固了我们作为全球创新领导者的地位。” 牛津大学创新副校长查斯·邦特拉教授（Professor Chas Bountra）说：“作为一所大学，我们继续将知识转化为对现实世界的影响，支持成立尖端的衍生公司，并将数百万英镑回馈给大学，用以资助未来的创新和研究。牛津大学科技创新公司所取得的成就反映出我们致力于突破极限、大胆合作并创造解决方案，为所有人打造更美好的未来。在牛津大学附属投资公司牛津科学企业（简称OSE）的推动下，我们与300多家衍生企业携手合作，为不断扩大的大学科学园提供支持，并通过我们的投资合作伙伴网络实现投资增长。这种合作促进了生命科学、人工智能/量子、太空和卫星、自动驾驶和赛车运动、能源和出版等领域的卓越集群，为牛津郡成为世界领先的创新中心做出了贡献。我们的目标是利用我们的人才、网络和突破性研究，通过创建一个'包容性创新生态系统'来应对全球面临的诸多挑战，使这里的每个人都能从中受益。” 《塑造未来：牛津大学科技创新影响报告》报告原文可在OUI官网查阅。 Dr Mairi Gibbs, Chief Executive of Oxford University Innovation said: ‘Oxford University Innovation remains committed to turning cutting-edge research into real-world solutions for the unprecedented challenges and opportunities of our time. ‘Our goal is to support innovators from across the University, ensuring that their ideas can create lasting economic, societal, and environmental impacts. Our future will be shaped by close collaboration between academia, industry, and society - and we are excited to lead the way in building that future here at Oxford.’ Baroness Nicola Blackwood, Oxford University Innovation Executive Chairwoman said: ‘As the world confronts increasingly complex challenges, our ability to innovate at speed and scale has never been more critical. Over the past year, Oxford University Innovation has continued to play a pivotal role in transforming ground-breaking research into tangible economic and societal benefits, strengthening our position as a global leader in innovation.’ Professor Chas Bountra, Pro Vice-Chancellor for Innovation at the University of Oxford said: ‘As a university we continue to translate knowledge into real-world impact, through support to form cutting edge spinouts, and the return of millions of pounds to the University to fund future innovation and research. Oxford University Innovation's achievements reflect our commitment to pushing boundaries, collaborating boldly, and creating solutions that shape a better future for all. Together we are linking with more than 300 spinouts, supporting our expanding university science parks and generating investment growth through our network of investment partners, driven by Oxford Science Enterprises. This collaboration has fostered remarkable clusters in areas such as life sciences, AI / quantum, space and satellite, autonomous vehicles and motorsport, energy, and publishing, contributing to a world-leading innovation hub here in Oxfordshire. Our aim is to use our talent, networks and ground-breaking research to tackle many of the challenges facing our planet, by creating an ‘inclusive innovation ecosystem’ which is benefitting everyone in the region.' Click ‘Read More’ to read the full report ‘Shaping the Future: Oxford’s Innovation Impact’ on the OUI website. Swipe left for English

并购疫苗细胞疗法免疫疗法

2024-08-04

·药明康德

超过40年等待终于迎来首批！面对这种每年60万人死亡的疾病不再束手无策

▎药明康德内容团队编辑疟疾这种致命的虫媒传染病由疟蚊传播，是人类最古老的敌人之一，长期以来一直挑战着科学家和医疗专业人员。根据世界卫生组织（WHO），2022年全世界有近2.5亿疟疾病例，造成超过60万人死亡。其中，又以五岁以下的儿童最易受疟疾影响。然而经过超过40年的不懈研究，科学界终于实现了曾被认为是不可能的目标：开发出有效的疟疾疫苗。今日药明康德内容团队便与读者一同回顾疟疾疫苗开发背后的故事，见证科学家努力不懈、突破自我的创新历程。图片来源：123RF 挑战“不可能的任务” 开发疟疾疫苗是一项极其艰巨的任务，因为疟疾寄生虫的性质非常复杂。与细菌和病毒不同，疟疾寄生虫在人体内经历多个阶段，每个阶段都有不同的蛋白质和抗原，使得免疫系统难以有效识别和攻击它。寄生虫躲避免疫防御的能力则进一步增加了疫苗开发的难度。因此在过往很长的一段时间，科学家普遍认为疟疾疫苗的开发是一件“不可能的任务”。然而，Ruth Nussenzweig博士并不这么认为。这位1928年出生于维也纳，后来移民到巴西，最终在纽约大学将自己的一生奉献给疟疾研究的女性免疫学家，拒绝接受疟疾寄生虫无法引发免疫反应的普遍看法。1966-1967年，她与其研究团队在《自然》等杂志上发表论文，指出接受反复静脉注射经X射线照射的伯氏疟原虫（Plasmodium berghei）的小鼠，体内都产生了高水平的抗体，并在之后接受疟原虫子孢子（sporozoite）感染时获得完全的保护。而经反复接种经辐射弱化子孢子的猴子也表现出抗体反应。这项研究证明了针对疟疾的免疫是可以被诱导产生的，这打破过往科学界的认知，并点燃了对疟疾疫苗开发的希望。在接下来的几年，Nussenzweig博士团队证明了子孢子靶向抗体与人类疟疾保护的获得有关。研究发现，许多在非洲疟疾高流行地区生活、已对疟疾感染产生抵抗力的人们体内，这种抗体频繁且高滴度地出现。此外，她的团队是首个生产靶向寄生虫抗原单克隆抗体的团队，并发现子孢子靶向抗体能够抑制子孢子进入培养细胞。相关研究在1980年发布于《科学》杂志上，这是首次有直接证据表明抗体可以通过靶向环子孢子蛋白（CSP）提供免疫保护，以对抗多种不同的疟原虫。这项开创性工作，为未来疫苗的开发奠定了基础。里程碑！首款疟疾疫苗问世基于Nussenzweig博士团队的突破性成果，Ripley Ballou博士和他的团队，与Smith Kline & French（现为GSK）公司合作，承担了将CSP发现转化为实际疫苗的艰巨任务。在早期的试验中，Ballou博士和其团队成员甚至在自己身上测试开发中的疫苗，并在之后将胳膊暴露在传播疟疾的蚊子下。这次试验当中，最终只有一个人没有感染疟疾，就连Ballou博士本人都发烧生病了。但尽管初期候选疫苗未能提供强而有力的保护，但该试验证明了疟疾疫苗的可行性，向前迈出了关键的一步。“这基本上表明这是可以做到的，这是可能的，”Ballou博士说道。疟疾疫苗开发的突破出现在Joe Cohen博士与GSK合作时。他从乙型肝炎疫苗中汲取灵感，巧妙地将疟疾CSP抗原与乙型肝炎病毒蛋白结合，创造一个能更有效刺激免疫系统的疫苗。Cohen博士经常在实验室工作到深夜，然而他的辛勤工作最终得到了回报，经过广泛测试，这款疫苗在早期试验中显示出希望，显示出适度但显著的儿童疟疾预防的效果。这款疫苗也就是后来获批上市的RTS,S（商品名Mosquirix）疫苗。图片来源：123RF RTS,S的开发标志着一个重要的里程碑。尽管由于该疫苗在试验中所展现的效力适中（30%到50%不等）而在最初受质疑，但这款疫苗表现出预防成千上万疟疾病例的潜力。WHO于2019年在加纳、肯尼亚和马拉维启动了试点项目，以评估大规模接种该疫苗的可行性和影响。这些项目的分析结果显示，RTS,S可以成功整合到常规免疫计划中，显著减少与疟疾相关的住院和死亡人数。2021年10月，RTS,S成为首个获WHO推荐用于预防儿童遭受疟疾感染的疫苗。在2019-2023年期间，已有超过二百万名居住在中、高疟疾感染风险地区的儿童接种该疫苗。一种能以数亿剂量供给的疟疾疫苗尽管RTS,S的问世拯救了无数宝贵的生命，但寻找更有效疫苗的努力仍在持续。由Adrian Hill博士领导的牛津大学研究团队通过改善RTS,S的设计而开发了R21疫苗。R21含有较高比例的CSP抗原，并使用Novavax公司所开发基于皂苷的佐剂Matrix-M。这种佐剂可增强免疫系统反应，使疫苗更具效力和持久性。Matrix-M佐剂刺激抗原呈递细胞进入注射部位，并增强局部淋巴结中的抗原呈递。因此与大多数疫苗通过诱导抗体产生来发挥保护作用不同的是，R21疫苗能够诱导个体产生T淋巴细胞免疫反应。这表示免疫系统具能力杀死受感染的肝细胞（或血细胞）内的寄生虫，因此个体能够获得比通过传统诱导抗体方式更好的保护。在一项早期进行的2期试验中，这款疫苗在5-17个月大的儿童中表现出了大约75%的显著效力。R21疫苗最终在2023年在加纳获得了监管批准，并在随后获得WHO的推荐。这一批准标志着一个关键的里程碑，由于R21可以较低成本进行大规模生产的特征，这使得非洲国家可获得数亿剂疫苗以应对严重的疟疾负担。一个没有疟疾威胁的未来 RTS,S和R21疫苗的开发代表了生物医学界在抗击疟疾方面的变革性突破。这些疫苗预计每年可挽救成千上万人的生命，特别是在撒哈拉以南的非洲。随着更多国家、地区预备进行大规模疫苗接种行动，全球卫生社区正处于一个关键阶段。但如何将疫苗推广、落实至疟疾高危地区的大多数民众极具挑战性。另一方面，部分专家也强调，尽管疫苗是一个强有力的工具，但它们必须成为包括蚊帐、喷洒杀虫剂和预防性治疗在内的综合抗疟疾战略的一部分。开发疟疾疫苗的历程漫长而艰辛，需要无数科学家、研究人员和医疗工作者的奉献和坚持。他们对医学的不懈追求和对公共卫生的坚定承诺带来了这一重要的成就。在我们享受这些突破所带来的益处的同时，我们向所有为这一努力做出贡献的人们表示深深的感谢。抗击疟疾的争战尚未结束，正如WHO疟疾疫苗负责人Mary Hamel博士所言，“我们正处于一个十字路口，有些地区疟疾感染的数字仍在攀升……这是一个不稳定的时期。”然而，RTS,S和R21的成功开发无疑是人类团结一致对抗致命疾病的绝佳见证。这些科学家的毅力和创新精神让我们比以往任何时候都更接近控制和潜在根除疟疾。通过持续的合作与创新，我们相信我们能在不久迎接一个没有疟疾威胁的未来。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Behind the malaria vaccines: A 40-year quest against one of humanity’s biggest killers. Retrieved August 2, 2024 from https://www.statnews.com/2024/08/01/malaria-vaccines-development-history-40-year-fight-mosquito-borne-disease/ [2] Malaria vaccines (RTS,S and R21). Retrieved August 2, 2024 from https://www-who-int.libproxy1.nus.edu.sg/news-room/questions-and-answers/item/q-a-on-rts-s-malaria-vaccine [3] R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana. Retrieved April 14, 2023 from https://www.ox.ac.uk/news/2023-04-13-r21matrix-m-malaria-vaccine-developed-university-oxford-receives-regulatory [4] Ghana approves University of Oxford's malaria vaccine ahead of key WHO review. Retrieved April 14, 2023 from https://www.fiercepharma.com/pharma/ghana-approves-university-oxfords-malaria-vaccine-ahead-phase-3-data [5] Professor Ruth Sonntag Nussenzweig (1928-2018) First steps towards a successful anti-sporozoite vaccine against malaria. Retrieved August 2, 2024 from https://www.scielo.br/j/rsbmt/a/jtx7JxCVtkjgVDjFtZn7Scc/?lang=en [6] Millions more children to benefit from malaria vaccine as UNICEF secures supply. Retrieved August 3, 2024 from https://www.unicef.org/press-releases/millions-more-children-benefit-malaria-vaccine-unicef-secures-supply [7] Adrian Hill: Malaria Vaccines. Retrieved August 3, 2024 from https://www.ndm.ox.ac.uk/research/malaria/adrian-hill-malaria-vaccines 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

疫苗

2023-04-17

·药明康德

速递 | 全球首批！人类历史上最致命疾病之一，有了新的应对手段

▎药明康德内容团队编辑近日，由牛津大学（The University of Oxford）研发、利用Novavax公司的佐剂技术，并由印度血清研究所PvT Ltd（SIIPL）生产的R21/Matrix-MTM疟疾疫苗，获得加纳（Ghana）食品和药物管理局的批准。根据牛津大学声明，这标志着R21/Matrix-M疟疾疫苗在全球范围内首次获得监管批准。疟疾是一种足以威胁生命的虫媒传染病。根据世界卫生组织最近的数据，2019年全世界有超过2.2亿疟疾病例，造成40万人死亡。其中，五岁以下的儿童最易受疟疾影响，占2019年全球疟疾总死亡人数的三分之二。R21/Matrix-M疟疾疫苗是一种低剂量疫苗，其特征为可以适中的成本进行大规模生产，使得非洲国家可获得数亿剂疫苗以应对严重的疟疾负担。该疫苗含有Novavax的Matrix-M，这是一种基于皂苷的佐剂，可增强免疫系统反应，使疫苗更具效力和持久性。Matrix-M佐剂刺激抗原呈递细胞在注射部位进入并增强局部淋巴结中的抗原呈递。▲疟疾由受疟原虫感染的蚊子叮咬传播（图片来源：123RF）牛津大学研究人员及其合作伙伴在去年报告指出，在接种三剂主要疫苗后一年进行的R21/Matrix-M加强剂试验中，疫苗对疟疾的高效力呈现持续性，且继续达到世界卫生组织（WHO）疟疾疫苗技术路线图的至少75%疫苗效力目标。这与2021年所公布的2b期试验结果一致，在此试验中R21/Matrix-M疫苗效力高达77%。最近的大型3期试验数据亦显示，该疫苗具有高效力和良好的安全性。牛津大学努菲尔德医学部詹纳研究所所长、R21/Matrix-M疫苗项目首席研究员Adrian Hill教授在牛津大学的声明中表示：“这标志着牛津大学在疟疾疫苗研究方面30年的高峰，设计并提供一种高效疫苗，可大规模供应给最需要的国家。”该疫苗获批用于5至36个月的儿童，这个年龄段的儿童死于疟疾的风险最高。希望这个重要批准将是使疫苗帮助加纳和非洲儿童有效抗击疟疾的第一步。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放‍参考资料：[1] R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana. Retrieved April 14, 2023 from https://www.ox.ac.uk/news/2023-04-13-r21matrix-m-malaria-vaccine-developed-university-oxford-receives-regulatory[2] Ghana approves University of Oxford's malaria vaccine ahead of key WHO review. Retrieved April 14, 2023 from https://www.fiercepharma.com/pharma/ghana-approves-university-oxfords-malaria-vaccine-ahead-phase-3-data免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

疫苗基因疗法

100 项与 RH5.1 相关的药物交易

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研发状态

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
间日疟原虫感染	临床2期	泰国	University of Oxford	2025-12-01
恶性疟	临床2期	布基纳法索	University of Oxford	2023-04-03

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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


NCT04318002 (Pubmed) 人工标引	临床1期	疟疾	60	RH5.1/Matrix-M	製觸築鑰築鹹鹽觸獵範(夢選淵廠鹽觸顧範糧顧) = Vaccinations were well-tolerated across both age groups. 選繭獵夢構鹽顧願醖鑰 (構網艱淵廠襯醖範築鹽 ) 更多	积极	2024-10-01