Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.

开始日期2019-07-16

申办/合作机构

Themis Bioscience GmbH

[+1]

NCT03635086

/ Completed临床2期

Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

开始日期2018-08-22

申办/合作机构

Themis Bioscience GmbH

NCT03101111

/ Completed临床2期

Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area

The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will be assessed.
MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will receive MV-CHIK; 20% will receive MMR vaccine.

开始日期2017-08-09

申办/合作机构

Themis Bioscience GmbH

[+1]

100 项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 相关的临床结果

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100 项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 相关的转化医学

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100 项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 相关的专利（医药）

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项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 相关的文献（医药）

2024-11-01·BioDrugs

Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure

Review

作者: Weber, Whitney C ; Streblow, Daniel N ; Coffey, Lark L

Chikungunya virus is an emerging mosquito-borne alphavirus that causes febrile illness and arthritic disease. Chikungunya virus is endemic in 110 countries and the World Health Organization estimates that it has caused more than 2 million cases of crippling acute and chronic arthritis globally since it re-emerged in 2005. Chikungunya virus outbreaks have occurred in Africa, Asia, Indian Ocean islands, South Pacific islands, Europe, and the Americas. Until recently, no specific countermeasures to prevent or treat chikungunya disease were available. To address this need, multiple vaccines are in human trials. These vaccines use messenger RNA-lipid nanoparticles, inactivated virus, and viral vector approaches, with a live-attenuated vaccine VLA1553 and a virus-like particle PXVX0317 in phase III testing. In November 2023, the US Food and Drug Administration (FDA) approved the VLA1553 live-attenuated vaccine, which is marketed as IXCHIQ. In June 2024, Health Canada approved IXCHIQ, and in July 2024, IXCHIQ was approved by the European Commission. On August 13, 2024, the US FDA granted priority review for PXVX0317. The European Medicine Agency is considering accelerated assessment review of PXVX0317, with potential for approval by both agencies in 2025. In this review, we summarize published data from pre-clinical and clinical trials for the IXCHIQ and PXVX0317 vaccines. We also discuss unanswered questions including potential impacts of pre-existing chikungunya virus immunity on vaccine safety and immunogenicity, whether long-term immunity can be achieved, safety in children, pregnant, and immunocompromised individuals, and vaccine efficacy in people with previous exposure to other emerging alphaviruses in addition to chikungunya virus.

2024-02-29·Journal of General Virology

Immunogenicity, safety and duration of protection afforded by chikungunya virus vaccines undergoing human clinical trials

Review

作者: Erku, Daniel ; Taylor, Adam ; Rao, Shambhavi ; Mahalingam, Suresh

Background. Chikungunya virus (CHIKV) causes chikungunya fever and has been responsible for major global epidemics of arthritic disease over the past two decades. Multiple CHIKV vaccine candidates are currently undergoing or have undergone human clinical trials, with one vaccine candidate receiving FDA approval. This scoping review was performed to evaluate the ‘efficacy’, ‘safety’ and ‘duration of protection’ provided by CHIKV vaccine candidates in human clinical trials.Methods. This scoping literature review addresses studies involving CHIKV vaccine clinical trials using available literature on the PubMed, Medline Embase, Cochrane Library and Clinicaltrial.gov databases published up to 25 August 2023. Covidence software was used to structure information and review the studies included in this article.Results. A total of 1138 studies were screened and, after removal of duplicate studies, 12 relevant studies were thoroughly reviewed to gather information. This review summarizs that all seven CHIKV vaccine candidates achieved over 90 % seroprotection against CHIKV after one or two doses. All vaccines were able to provide neutralizing antibody protection for at least 28 days.Conclusions. A variety of vaccine technologies have been used to develop CHIKV vaccine candidates. With one vaccine candidate having recently received FDA approval, it is likely that further CHIKV vaccines will be available commercially in the near future.

2023-10-01·Vaccine

A measles virus-based vaccine induces robust chikungunya virus-specific CD4+ T-cell responses in a phase II clinical trial

Article

作者: de Swart, Rik L ; Sette, Alessandro ; Geers, Daryl ; Comvalius, Anouskha D ; Schmitz, Katharina S ; de Vries, Rory D ; Nieuwkoop, Nella J ; Tschismarov, Roland ; Ramsauer, Katrin ; Weiskopf, Daniela

Chikungunya virus (CHIKV) is an alphavirus transmitted by mosquitos that causes a debilitating disease characterized by fever and long-lasting polyarthralgia. To date, no vaccine has been licensed, but multiple vaccine candidates are under evaluation in clinical trials. One of these vaccines is based on a measles virus vector encoding for the CHIKV structural genes C, E3, E2, 6K, and E1 (MV-CHIK), which proved safe in phase I and II clinical trials and elicited CHIKV-specific antibody responses in adult measles seropositive vaccine recipients. Here, we predicted T-cell epitopes in the CHIKV structural genes and investigated whether MV-CHIK vaccination induced CHIKV-specific CD4⁺ and/or CD8⁺ T-cell responses. Immune-dominant regions containing multiple epitopes in silico predicted to bind to HLA class II molecules were found for four of the five structural proteins, while no such regions were predicted for HLA class I. Experimentally, CHIKV-specific CD4⁺ T-cells were detected in six out of twelve participants after a single MV-CHIK vaccination and more robust responses were found 4 weeks after two vaccinations (ten out of twelve participants). T-cells were mainly directed against the three large structural proteins C, E2 and E1. Next, we sorted and expanded CHIKV-specific T cell clones (TCC) and identified human CHIKV T-cell epitopes by deconvolution. Interestingly, eight out of nine CD4⁺ TCC recognized an epitope in accordance with the in silico prediction. CHIKV-specific CD8⁺ T-cells induced by MV-CHIK vaccination were inconsistently detected. Our data show that the MV-CHIK vector vaccine induced a functional transgene-specific CD4⁺ T cell response which, together with the evidence of neutralizing antibodies as correlate of protection for CHIKV, makes MV-CHIK a promising vaccine candidate in the prevention of chikungunya.

项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 相关的新闻（医药）

2024-02-21

·BioSpace

Bavarian Nordic Puts Kibosh on Cancer Vaccine, Focuses on Infectious Diseases

Pictured: Syringe drawing from a series of vials/i Danish biotech Bavarian Nordic announced Wednesday it is discontinuing its immuno-oncology program and will focus its R&D efforts on infectious diseases. Pictured: Syringe drawing from a series of vials/iStock, NikiLitov Danish biotech Bavarian Nordic announced on Wednesday, as part of its preliminary 2023 financial results, that it would halt any future work on its cancer vaccine program. According to Bavarian Nordic, its cancer vaccine TAEK-VAC has reached a stage where more investments are required. The company would also have faced stiff competition in the cancer vaccine space as big names such as BioNTech, Merck and Moderna are making progress on their respective cancer vaccines. The TAEK-VAC program will stop with no plans to invest in an immune-oncology vaccine. The company’s website details the TAEK-VAC vaccine , which sought to use the body’s immune system to find and eliminate cancer cells. A Phase I trial of the vaccine was ongoing with the first stage of the study completed while stage two was open for enrollment. Bavarian Nordic said it will instead focus on infectious diseases through “product improvements” and new vaccine development to stay competitive. The company is working on a vaccine for the chikungunya virus and equine encephalitis, a rare mosquito-borne disease. For its chikungunya vaccine, Bavarian Nordic is currently conducting a Phase III trial. The results , which were posted in August 2023, showed that 98% of patients who took the vaccine had a strong induction of chikungunya-inducing antibodies. In addition, 97% of patients in the study had antibodies induced within two weeks of vaccination. Separately, an equine encephalitis vaccine has finished a Phase I trial and is being developed via a contract with the U.S. government. Bavarian Nordic disclosed that the development costs were DKK 850 million ($149 million) in 2023, with nearly half of those costs related to its chickungunya program. Bavarian Nordic’s preliminary 2023 results show the company secured revenue of over DKK 7 billion ($1 billion) compared to 3.1 billion ($449 million) in 2022. The biotech said that the spike in revenue was caused by a rise in sales of smallpox/mpox vaccines following an outbreak in 2022 and growth in the travel health business after an acquisition last year. Tyler Patchen is a staff writer at BioSpace . You can reach him at tyler.patchen@biospace.com . Follow him on LinkedIn .

临床结果疫苗临床1期财报临床3期

2024-02-21

·BioSpace

Bavarian Nordic Puts Kibosh on Cancer Vaccine, Focuses on Infectious Diseases

Pictured: Syringe drawing from a series of vials/iStock, NikiLitov Danish biotech Bavarian Nordic announced on Wednesday, as part of its preliminary 2023 financial results, that it would halt any future work on its cancer vaccine program. According to Bavarian Nordic, its cancer vaccine TAEK-VAC has reached a stage where more investments are required. The company would also have faced stiff competition in the cancer vaccine space as big names such as BioNTech, Merck and Moderna are making progress on their respective cancer vaccines. The TAEK-VAC program will stop with no plans to invest in an immune-oncology vaccine. The company’s website details the TAEK-VAC vaccine, which sought to use the body’s immune system to find and eliminate cancer cells. A Phase I trial of the vaccine was ongoing with the first stage of the study completed while stage two was open for enrollment. Bavarian Nordic said it will instead focus on infectious diseases through “product improvements” and new vaccine development to stay competitive. The company is working on a vaccine for the chikungunya virus and equine encephalitis, a rare mosquito-borne disease. For its chikungunya vaccine, Bavarian Nordic is currently conducting a Phase III trial. The results, which were posted in August 2023, showed that 98% of patients who took the vaccine had a strong induction of chikungunya-inducing antibodies. In addition, 97% of patients in the study had antibodies induced within two weeks of vaccination. Separately, an equine encephalitis vaccine has finished a Phase I trial and is being developed via a contract with the U.S. government. Bavarian Nordic disclosed that the development costs were DKK 850 million ($149 million) in 2023, with nearly half of those costs related to its chickungunya program. Bavarian Nordic’s preliminary 2023 results show the company secured revenue of over DKK 7 billion ($1 billion) compared to 3.1 billion ($449 million) in 2022. The biotech said that the spike in revenue was caused by a rise in sales of smallpox/mpox vaccines following an outbreak in 2022 and growth in the travel health business after an acquisition last year. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

临床1期疫苗临床3期财报临床结果

2023-11-15

·药智网

一场针对蚊子的新「疫苗研发」竞赛

蚊子轻轻一咬，一场大病跑不了，说的就是蚊子所携带的基孔肯雅热病毒。或许你对这个病毒名字感到陌生，但过去长久的时间里，基孔肯雅病毒一直无药可用。幸运的是，近日全球首款基孔肯雅病毒疫苗已获批上市，为该病的防治注入了一剂强心针。近日，FDA加速批准Valneva公司所研发的基孔肯雅热疫苗Ixchiq上市，用于18岁或更大年龄接触基孔肯雅病毒风险较高的人群使用，这是全球首款基孔肯雅热疫苗。随着Ixchiq的获批，一场针对蚊子的新「疫苗研发」竞赛正式拉开帷幕。01有效性高达98.9%，全球首款疫苗诞生基孔肯雅病毒属于披膜病毒科的甲病毒属，是一种主要由蚊虫传播的球形包膜单股正链RNA病毒，基孔肯雅病毒主要通过受感染的蚊子叮咬人类，从而将病毒传播。感染者的临床表现通常为突发高热和关节痛等症状，在Ixchiq获批上市之前，全球无一款特异性药物和疫苗，一般采用对症下药的治疗方式。由于该疾病主要通过蚊子传播，可称之为“蚊祸”。从区域来看，感染人数最多的区域当属非洲、东南亚的热带和亚热带地区以及美洲部分地区，但却一直无特异性药物可用。近日，全球首款基孔肯雅病毒疫苗已经问世，为该病的防治注入了一剂强心针。基孔肯雅活疫苗Ixchiq由Valneva公司所研发，在获批之前，Ixchiq已被FDA授予快速通道和突破性疗法称号，其上市申请也得到了优先审评。该疫苗的临床3期试验终点为接种疫苗后的28天受试者体内具有血清保护性基孔肯雅病毒抗体的群体占比。临床3期结果显示，98.9%接受Ixchiq的受试者在接种该疫苗28天后，体内基孔肯雅病毒中和抗体达到了保护水平。接种疫苗6个月时间以后，有96.3%的受试者仍有足够的基孔肯雅病毒抗体。安全性方面，最常见的不良反应为注射部位疼痛、头痛、疲劳、肌痛、关节痛、发烧和恶心。基于不良反应的发生，FDA要求该公司对该疫苗进行上市后研究，以评估Ixchiq给药后发生严重不良反应的风险。有效性方面，Ixchiq的效果毋庸置疑，高达98.9%的有效性，可确保有效的对抗基孔肯雅病毒。但Ixchiq目前所面临的某些安全问题比如不良反应，恐怕还需要真实世界的数据来证明。022款即将撞线，在研药物及疫苗分析除了Ixchiq外，全球基孔肯雅病毒药物或疫苗进展如何？笔者通过药智数据查询到，在研的药物及疫苗有以下几款处于临床阶段，详见下表1。表1 在研基孔肯雅病毒药物/疫苗数据来源：药智数据除Ixchiq已获批上市外，当前全球还有两款药物及疫苗处于临床3期阶段，一款处于临床2期阶段，两款处于临床1期阶段，国内目前无基孔肯雅病毒药物或疫苗在研。PXVX-0317为一款基于VLP的佐剂疫苗，同样用于预防基孔肯雅病毒。该疫苗目前已获得FDA的突破性疗法认定以及快速通道资格。此外，在欧洲该疫苗也获得了PRIME资格。该疫苗预计明年申请上市。临床方面，早在今年八月份，Bavarian公司就公布了其在研基孔肯雅病毒疫苗PXVX0317的临床3期试验结果。结果显示，受试者注射该疫苗22天后，接种后第22天的结果显示，PXVX0317在受试者中具有高度免疫原性，98%的受试者可诱导强烈的基孔肯雅中和抗体，该临床3期试验达主要终点。在接种后2周，PXVX0317在97%的受试者中诱导产生了显著的中和抗体，该数据进一步证明了PXVX0317可快速引发保护性的免疫水平。除此以外，PXVX0317所产生的免疫应答较为持久，有86%的受试者在接种疫苗6个月以后仍具有达血清保护性的中和抗体浓度。安全性方面，PXVX0317在受试者中表现出了较好的耐受性，不良事件主要为轻度或中度。CHIKUNGUNYA为Bharat所研发的一款疫苗，是Bharat的9条临床管线之一，当前处于临床3期阶段，未查询到相关临床数据。除了以上几款，MV-CHIK也处于临床2期阶段。该管线是默沙东收购Themis所得，虽然当时Themis已完成二期临床试验，但由于试验数据未达到预计终点，加之Ixchiq进展较快，所以默沙东于今年2月暂停了该疫苗的开发。以上几款即目前全球所有的基孔肯雅病毒在研药物及疫苗，除已上市的Ixchiq外，目前进展最快的当属Bavarian的PXVX-0317，预计2024年进行注册申请。受患者群体以及区域性的影响，当前全球研发基孔肯雅病毒药物及疫苗的热情并不是很高。但目前基孔肯雅病毒传播速度越来越快，传播的国家以及地区也愈加广泛，这一现象应引起大家的关注。尤其是我国，当前无一款基孔肯雅病毒疫苗在研。相信未来，将掀起一场针对蚊子的新「疫苗研发」竞赛。03小结基孔肯雅病毒已影响全球多个国家和地区，多次爆发和流行，我国也经常有境外输入病例，已成为重要的全球性公共卫生问题之一。如今随着Ixchiq获批上市，“蚊祸”能否成为过去时？此外，基孔肯雅热虽然主要在国外流行，但是东南亚各国的疫情对我国的威胁依旧较大，不知国内对于基孔肯雅病毒疫苗以及药物的研发是否会提上日程？敬请期待。参考文献[1]https://www.prnewswire.com/news-releases/la-fda-aprueba-la-primera-vacuna-para-prevenir-la-enfermedad-causada-por-el-virus-del-chikungunya-859325668.html[2]李佳,张晓敏,万成松,等.基孔肯雅病毒的流行概况[J].热带医学杂志,2019(10):5.DOI:CNKI:SUN:RDYZ.0.2019-10-030.[3]https://www.bavarian-nordic.com/investor/news/news.aspx?news=6816[4]https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine-ixchiq/#_ftn2声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八斤转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

疫苗突破性疗法优先审批临床3期临床2期

100 项与 Chikungunya virus vaccine(Themis Bioscience GmbH) 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
基孔肯雅热	临床2期	奥地利	Themis Bioscience GmbH	2016-08-17
基孔肯雅热	临床2期	德国	Themis Bioscience GmbH	2016-08-17

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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


NCT03807843 (V184-006, CTgov)	临床2期	基孔肯雅热	41	V184 (V184)	淵鏇願選衊糧網鬱糧窪(鬱艱遞願淵蓋網選鬱鏇) = 積艱簾繭構鏇鹹鏇範糧糧蓋構糧廠膚築鏇襯顧 (壓餘鬱醖夢鬱夢製襯淵, 製築餘觸鑰膚餘顧鹽醖 ~ 鬱選蓋築網構構襯遞鬱) 更多	-	2022-05-16
				Placebo (Placebo)	淵鏇願選衊糧網鬱糧窪(鬱艱遞願淵蓋網選鬱鏇) = 獵鹹製簾鹹醖繭鏇選糧糧蓋構糧廠膚築鏇襯顧 (壓餘鬱醖夢鬱夢製襯淵, 衊壓鑰鏇憲鹽鬱鑰鬱憲 ~ 襯襯繭淵衊選鬱遞顧膚) 更多
NCT03635086 (V184-005, CTgov)	临床2期	基孔肯雅热	60	MV-CHIK lyophilised formulation, low dose (Group A: Two MV-CHIK Lyophilized Low Dose)	遞繭顧餘積蓋簾鹽鑰簾(網鹽鑰糧壓簾網壓簾夢) = 願鬱鑰範積膚簾膚憲鬱觸壓餘簾顧壓襯願淵顧 (淵糧襯顧鏇壓壓餘鏇鬱, 憲範襯網醖淵構淵壓觸 ~ 觸鑰鹹築顧選醖夢窪觸) 更多	-	2021-10-20
				MV-CHIK liquid frozen formulation, low dose (Group B: Two MV-CHIK Liquid Frozen Low Dose)	遞繭顧餘積蓋簾鹽鑰簾(網鹽鑰糧壓簾網壓簾夢) = 憲鏇鹽蓋淵齋艱繭襯積觸壓餘簾顧壓襯願淵顧 (淵糧襯顧鏇壓壓餘鏇鬱, 憲鬱顧膚淵鬱窪構遞鬱 ~ 築顧廠鏇獵繭觸鹽廠獵) 更多