A Phase I/IIa (Multi-center, Open-label, Phase I and Multi-center, Open-label, Phase IIa ) Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

This is Phase 1 and 2a, Multi-center, Open-label study designed to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo vaccine in Healthy Adult Volunteers

开始日期2022-03-22

申办/合作机构

EyeGene, Inc.

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100 项与 EG COVID vaccine (EyeGene) 相关的临床结果

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100 项与 EG COVID vaccine (EyeGene) 相关的转化医学

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100 项与 EG COVID vaccine (EyeGene) 相关的专利（医药）

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项与 EG COVID vaccine (EyeGene) 相关的文献（医药）

2024-12-01·Vaccine

Determinants of influenza and COVID vaccine uptake in healthcare workers: A cross-sectional survey during the post-pandemic era in a network of academic hospitals in France

Article

作者: Tattevin, Pierre ; Paris, Christophe ; Thibault, Vincent ; Saade, Anastasia ; Gaudouen, Hervé ; Ménard, Guillaume

OBJECTIVESAlthough influenza and COVID vaccines are recommended for healthcare workers (HCWs), vaccine coverage is sub-optimal for influenza in this population, and the situation did not improve during the COVID pandemic. We aimed to estimate influenza and COVID vaccine coverage among HCWs and their determinants after the COVID pandemic.METHODSWe performed a cross-sectional study between May and July 2023 among HCWs to estimate influenza and COVID vaccination coverage during the 2022-2023 season, and its determinants, using a web-based anonymous questionnaire. We performed a multivariable regression analysis to assess factors associated with vaccine uptake.RESULTSOf the 9158 HCWs invited to participate, 1587 (16 %) completed the questionnaire, primarily paramedics (n = 479, 30 %), medics (n = 310, 20 %), administrative staff (n = 249, 16 %), and nurse assistants (n = 237, 15 %). Vaccine coverage during the 2022-2023 season was estimated at 64 % [CI95 % 61-66] for influenza, and 42 % [CI95% 39-44] for COVID. Vaccinated HCWs reported adverse events rates of 8 % (n = 122) after influenza, and 37 % (n = 579) after COVID vaccines. On multivariable analysis, being a medic or over 40 years old was associated with both influenza and COVID vaccine uptake. Suggested interventions to boost vaccine uptake were primarily to facilitate access to vaccination in the workplace, and to better inform HCWs on the risks and benefits of these vaccines.CONCLUSIONSEasy access to COVID and influenza vaccines in the workplace, and better information about their benefits, may improve their uptake. Future vaccination campaigns should communicate more about potential adverse effects, and effectiveness.

2024-10-01·Drug Safety

What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study

Article

作者: Riefolo, Fabio ; Trifirò, Gianluca ; L'Abbate, Luca ; Sonderlichová, Simona ; Villalobos, Felipe ; Lieber, Thomas ; Raethke, Monika ; Ciccimarra, Francesco ; Morton, Kathryn ; van Hunsel, Florence ; O'Shaughnessy, Fergal ; Farcas, Andreea ; Thurin, Nicolas H ; Janneke, Giele-Eshuis ; Mulder, Erik ; Luxi, Nicoletta ; Bellitto, Chiara ; Sturkenboom, Miriam C ; Marques, Francisco B

BACKGROUNDThe safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.AIMTo measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.METHODSA prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project's web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.RESULTSA total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001).CONCLUSIONThe overall safety profile of COVID-19 vaccines in immunocompromised people was favourable, with minor differences as compared to non-immunocompromised vaccinees. Participants mostly experienced mild ADRs, mainly reported after the first dose of Vaxzevria and Jcovden vaccines. Serious ADRs and AESI were rare.

2024-10-01·Indian Journal of Hematology and Blood Transfusion

Naturally Occurring Anti-D in a Male Blood Donor, Unresolved Mystery

Article

作者: Basnotra, Ritika ; Mallhi, R S ; Mallhi, R. S. ; Shrotriya, Abhipsa ; Philip, Joseph

In accordance with numerous national and international criteria, screening donated blood for abnormal antibodies against red cell antigens is crucial for patient safety. Antibodies can be formed by three mechanisms: by immune responses, naturally occurring, or passively acquired. In accordance with departmental policy, ICT was performed on a 30-yearold male blood donor's sample in addition to ABO Rh grouping. He tested A Rh Dnegative and had a positive ICT (+ 2). Anti-D was identified by using the antibody screening and identification panel. Retesting revealed similar results, so we called the donor. We were unable to find a source for the Rh isoimmunization during the course of his history. On further work-up, we found that antibodies reacted only in the antiglobulin phase with no reaction in the saline phase, suggesting an IgG type of antibody. Also, the anti-D titers (IgG) of the donor were up to 1:32. All potential sources of Rh isoimmunization have been ruled out for a male donor. Therefore, we assume that this donor has naturally occurring anti-D, perhaps created by certain environmental factors, bacteria, or components of the COVID vaccine that have cross-reactivity with the D antigen. This instance emphasizes how crucial the ICT test on the donor blood is. In our case, all potential causes of alloimmunization were ruled out, leaving only exposure to antigens with antigenic similarity to D antigens as a viable explanation.

项与 EG COVID vaccine (EyeGene) 相关的新闻（医药）

2023-09-03

·生物制品圈

韩国首个新冠mRNA疫苗面临冰点，政府停止投入，临床试验难以继续。

2023 年 8 月 10 号，据 Bussiness Korea 报道，EYEGENE 公司正在计划一旦 EG-COVID-001—韩国首款新冠 mRNA 疫苗下个月在澳大利亚完成临床 2a 期试验就立即寻求外部投资进行联合开发或者技术转让。目前，EYEGENE 公司研发资金匮乏，仅澳大利亚进行的 2a 期试验就投入了 200 亿韩元的自有资金，三期临床还需要超过 1000 亿韩元的大窟窿填补，雪上加霜的是，韩国政府对 mRNA 疫苗的政策资金支持也已停止。随着新冠 mRNA 疫苗风口的过去，众多从事新冠 mRNA 疫苗研发的公司资金短缺，尤其是先前已进入临床试验的公司，更是面临进退维谷的窘境。遥想当初，韩国业内锣鼓喧天，人人撸起袖子准备大干一场。2021 年 9 月，Hanmi Pharmaceutical、GC Pharma 和 ST Pharm 三家韩国制药巨头成立 K-mRNA 联盟，其中 Hanmi 负责原料生产，GC 负责罐装，ST 负责 CDMO，旨在推进新冠 mRNA 疫苗的开发和大规模生产。同时，还有 3 家冉冉升起的 mRNA 疫苗研发初创企业也仅跟着成立 mRNA Bio 初创联盟，分别是 EYEGENE，GeneOne Life Science，Quratis。如今，聚义竖起的大旗已倒下，联盟里的成员只能各回各家，各找各妈。当初谁也不会想到，新冠 mRNA 疫苗的一片蓝海还就只容得下最早吃螃蟹的两家，对于后来者，你追的越紧，打水漂的银子越多。我们曾经介绍过 mRNA 疫苗在澳大利亚本土化的过程，本期内容主要回顾一下，从一片火热到遭遇冰点，两年多以来，mRNA 技术在韩国这片制造业发达的土地上经历了怎样的进程。2021 年 5 月 22 号，三星生物制品公司与 Moderna 公司达成协议，为其新冠 mRNA 疫苗提供大规模、商业化的灌装生产，但是，并不涉及 mRNA 疫苗本身的生产。同年 10 月，韩国卫生部批准三星生物制品公司生产的 Moderna 新冠 mRNA 疫苗用于国内紧急使用。韩国当然不会满足仅仅作为 Moderna 的初级代工，在政府资金的大力支持下，谋求短期内快速实现国产新冠 mRNA 疫苗的突破。2022 年 6 月 23 号，嘉泉大学主办并且发起新变种传染病 mRNA 疫苗项目（KmVAC），由医学院洪基钟教授任主任。该项目计划到 2025 年投资总计 900 亿韩元的研究资金，其中包括 688 亿韩元的政府捐款，宗旨是扶持韩国国内 mRNA 疫苗研发企业，完成国产 mRNA 疫苗平台的快速搭建，两年内产生进入临床试验的 mRNA 疫苗。在启动会上，多家韩国疫苗公司和研究机构对于未来 mRNA 疫苗的研究计划作了详细阐述。通过这些报告，我们能够对韩国 mRNA 疫苗行业的发展情况有一个大致的了解。👀 QuratisQuratis 成立于 2016 年，是韩国一家专门从事免疫相关疫苗开发的公司。目前，主要开发项目为适用于成人和青少年的结核病疫苗 QTP101 和自复制新冠 mRNA 疫苗 QTP104，公司正在全力加速这两款疫苗的商业化上市。QTP101 是一款针对成人和青少年的结核菌蛋白亚单位疫苗，由 ID93 和 GLA-SA 佐剂组成。ID93 是一种融合蛋白，由强毒抗原（Rv2608、Rv3619、Rv3620）和潜伏抗原（Rv1813）组成。GLA 是单磷酰脂质 A 的衍生物，是脂多糖 (LPS) 的解毒形式。它作为TLR4激动剂发挥作用，有效诱导 Th1 介导的免疫反应。QTP101 能增强人体由卡介苗形成的免疫反应，只需三剂即可预防结核病，显示出更高的安全性。QTP101 于 2021 年在韩国完成成人和青少年的 I 期临床试验，并于去年获准开展 2b/3 期临床试验。QTP104 目前正在韩国完成一期临床试验，是韩国开发的首个自复制 mRNA 疫苗。此外，Quratis 还在计划开发基于自复制 RNA 技术的下一代结核菌疫苗 QTP102。👀 国际疫苗研究所与 SK Bioscience国际疫苗研究所（Internation Vaccine Institute,IVI）是一个独立的非营利性国际组织，由联合国开发计划署 (UNDP) 倡议于 1997 年成立，其宗旨是为全球公共卫生发现、开发和提供安全、有效且负担得起的疫苗。IVI 总部位于首尔，由韩国及 39 个成员国和世界卫生组织共同主办。IVI 希望与嘉泉大学、SK Bioscience 共同来开发拉沙热 mRNA 疫苗项目。SK Bioscience 是韩国一家大型疫苗研发生产公司，于 2018 年从 SK 化学拆分出来。多年来，SK Bioscience 在疫苗领域取得众多成就，例如，于 2015 年推出韩国首个基于细胞培养的三价流感疫苗，世界上第一个基于细胞培养的四价流感疫苗，世界上第二个带状疱疹病毒疫苗和韩国第二个水痘疫苗。👀 Quad MedicineQuad Medicine 是一家拥有医疗微针平台技术的公司，该技术可用于多种用途，包括可透皮给药的疫苗、合成药物和诊断医疗设备。微针（MAP）免疫是一种通过皮肤传递抗原的方法，同时产生全身和局部免疫。Quad Medicine 希望与嘉泉大学、ST PHARM 共同协作来生产基于微针技术的新冠 mRNA 疫苗。👀 RNAGENERNAGENE 成立于 2018 年，是韩国首家从事 mRNA 疫苗/药物研发的生物公司，主要开发基于 mRNA 技术的预防性疫苗、癌症免疫疗法及蛋白替代疗法。在 2022 年，RNAGENE 与韩国国立卫生研究院签订 2 项服务合同，一个是生产编码结核分枝杆菌抗原的 mRNA，一个是开发增强适应性免疫，提升免疫持续时间的 RNA 疫苗技术。遗憾的是，迄今为止，这家公司在新冠 mRNA 疫苗研发方面并未取得任何值得引入注意的成绩，在其他管线也没有进入临床试验阶段的项目。👀 西江大学与 PhytoMabSeong-Ryong Kim (金成龍)教授是韩国首尔西江大学生命科学系植物分子生物实验室的领导者，研究方向主要集中在利用光合生物合成蛋白质，例如，利用植物表达系统生产日本脑炎病毒疫苗或者抗体药物等。2022 年，他开始主持研发寨卡病毒 mRNA 疫苗研发项目。比较特别的是，他意图将 RNA 聚合酶与加帽酶融合在一起，形成 ctDdRp，同时实现转录和加帽反应。PhytoMab 是韩国一家合成生物学公司，利用 Crispr/Cas9 技术开发了首个生产人源化生物制品的植物干细胞系。金成龍教授希望与 PhytoMab 展开合作，利用其无细胞表达体系来生产体外转录翻译所需的酶。👀 ST PHARMST PHARM 是一家成立于 1983 年的老牌韩国 CDMO 公司，为许多大型制药公司和生物公司提供 GMP 级别的活性药物成分、中间体的顶级定制化服务，拥有非常可靠的工艺开发及放大优化方面的经验。从 2020 年开始，随着新冠 mRNA 疫苗的崛起，ST PHARM 开始重点布局 mRNA 方向，主要包括 3 个方面：mRNA 疫苗的生产制造，帽类似物生产，LNP 脂质体成分生产。👀 逆水行舟尽管今年以来韩国 mRNA 行业逐渐进入冷静期，但是，依然有人逆水行舟，持续推进。新变种染病 mRNA 疫苗项目组（KmVAC）与韩国资深 CDMO 公司 BMI Korea 签订协议，双方计划共同推进 mRNA 疫苗相关的研究和基础设施建设，该公司在 2022 年建设了年产能超过 5000 万剂的新冠 mRNA 疫苗生产线。此外，今年 3 月份，KmVAC 还与 Moderna 建立合作伙伴关系，以便更加有效地开发新发传染病 mRNA 疫苗的研发。三养生物制药公司 (Samyang Biopharmaceuticals Corporation) 成立于 1995 年，前身是三养社的制药业务。今年 4 月份，三养生物制药公司将 NanoReady 药物递送技术授权给 LG 化学，负责向其提供关键原料，双方共同开发基于 mRNA 技术的癌症疗法。👀 结论新冠 mRNA 疫苗的成功使得韩国政府、制药巨头以及初创新秀意识到 mRNA 技术即将掀起的医药革新浪潮，因此，政府牵头成立专门的项目组，给予高校和企业资金政策支持，寄希望于搭建完全国产化的 mRNA 疫苗生产线，以应对将来可能出现的新变种传染病。早期，人们普遍觉得 mRNA 疫苗研发周期短，生产简单快速，所以全部扎进国产新冠 RNA 疫苗的研发赛道，野蛮扩张产能，自信短期内便能取得突破进行商业化生产。潮水褪去，韩国首个新冠 mRNA 疫苗的临床试验面临资金不足，难以维系的困境，那些扩张的生产线也是空等一场。很多时候人们充满激情的时候，经验是远远不足的，但是，至少这种蛮干开启了韩国 mRNA 技术国产化之路。相比澳大利亚来说，韩国自身拥有非常深厚的制造业基础，因此，整个 mRNA 技术产业化要走得更加成熟。比较遗憾的是，除了新冠 mRNA 疫苗，韩国企业并未在其他方向取得任何突破性的进展。对于 mRNA 技术来说，未来两三年如果不能有其他方向的产品上市，依然只有一朵新冠 mRNA 疫苗的过气红花，那么，不仅是韩国，其他各国的 mRNA 研发/生产企业都可能会面临更加严酷的寒冬。由生物制品圈&抗体圈主办的“2023生物制品工艺发展大会”将于9月22-23日在上海举办，本次大会将主要聚焦生物制品前沿技术、CMC、生产、工艺等热点话题进行探讨交流，涉及人用疫苗、兽用疫苗、抗体药、细胞治疗、基因治疗等生物制品领域。届时将邀请生物制品领域经验权威的专家进行报告，欢迎各界同仁参会学习交流。1.会议名称：2023生物制品工艺发展大会2.会议时间：2023年9月22-23日（周五、周六）3.会议地点：上海（酒店定向通知）4.主办单位：生物制品圈、抗体圈5.媒体支持：药时空、药创客、细胞基因研究圈6.报名方式及费用：扫描识别下方二维码进行报名登记。转发分享福利：生物医药研发企业、科研院校和监管机构人员，前100位报名人员转发分享本通知至朋友圈可免费参会（不含餐饮）报名后，加微信13585867695发截图给工作人员即可。组委会获得报名信息后，根据报名信息进行初筛，并进一步与报名者沟通确认，实现精准邀请，最终有机会进入大会微信群（严格审核通过）。各类商务合作咨询：13585867695（同微信）大会日程识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

信使RNA疫苗临床3期临床2期临床1期

2023-08-03

·FiercePharma

As sales crater, Moderna sees hope in private COVID vaccine market and RSV launch

Moderna's sales sank 93% year-over-year to $344 million during the second quarter. Even as Moderna chugs through another post-pandemic year, the biotech has raised its COVID-19 vaccine revenue projection in the expectation that it can deliver a strong showing in the private market. And it's touting potential launches as it looks toward the next chapter. After a severe second-quarter sales decline, the company raised its Spikevax sales guidance to a range of $6 billion to $8 billion, up from its previous forecast of $5 billion. The company generated $344 million during the second quarter of 2023, a 93% decline from $4.75 billion it pulled down in the same period last year. Its quarterly loss came in at $1.4 billion. While the total market size for COVID vaccines this fall remains unknown, Moderna said that new commercial contracts have enabled it to get a better grasp on expected sales for the rest of the year. Moderna expects around 100 million COVID vaccine doses to be administered in the U.S. this fall, below the average of 150 million doses for an average flu season. Moderna has described this year as "transitional" as it shifts some of its focus to other projects, including its respiratory syncytial virus (RSV) vaccine. As for that program, the company has initiated a rolling FDA submission. It expects to launch in 2024, behind rivals from GSK and Pfizer, which both won approvals this year. While Moderna knows its vaccine will launch well behind formidable rivals, the company is “very confident” in what it believes is the “best-in-class profile” of its product, chief commercial officer Arpa Garay said on a conference call. Moderna anticipates slower uptake at the start of the rollout, but it's hopeful a CDC recommendation could jumpstart the launch. Meanwhile, the company’s adjuvant melanoma vaccine is enrolling patients for a phase 3 trial. This one is tracking strongly with analysts, with Third Bridge’s Lee Brown flagging its “potential to profoundly change the treatment of melanoma,” the analyst wrote in a note to clients.

疫苗财报

2023-08-03

·Firstwordpharma

Moderna hikes full-year outlook for COVID vaccine despite Q2 sales dive

Moderna reported Thursday that revenues for the second quarter sank to $344 million, compared to $4.7 billion the same time last year, although it still came in ahead of the $308 million analysts had projected. According to Moderna, the weaker performance was largely due to a 94% decline in sales of its COVID-19 vaccine, which brought in $293 million over the course of the three-month period.Moderna also posted a narrower-than-expected net loss of $1.4 billion during the second quarter, compared to a profit of $2.2 billion in the corresponding 2022 period. Company shares rallied as much as 8.4% in premarket trade Thursday following the release of the earnings report."Second-quarter sales were on target, given the seasonal nature of COVID," stated CEO Stéphane Bancel. Looking ahead, Moderna said it now expects sales of its COVID-19 vaccine to be between $6 billion and $8 billion this year, up from guidance it provided in May of at least $5 billion.Eye on US vaccine uptake this fall"The US commercial team appears to be making strong progress to get new contracts in place for this fall," remarked Third Bridge analyst Lee Brown.During the company's earnings call, chief commercial officer Arpa Garay suggested the "biggest factor" that will determine whether sales fall within the new range is US vaccine uptake from September to December, as the shots enter the US commercial market for the first time. Garay noted that the company expects US demand of 50 million to 100 million doses in the autumn, but acknowledged that it is "difficult to accurately predict market volumes and…how many Americans will come in this fall for their shots."Moderna said it is in talks with purchasers in the US, EU and other parts of the world for additional possible orders, and noted that $1 billion in previously anticipated 2023 sales were pushed to 2024. The company also recently presented "potent neutralisation and cross-reactivity" data for its updated COVID vaccine mRNA-1273.815, which targets the XBB.1.5 Omicron subvariant, and has submitted it to regulatory bodies for approval as well, saying it "is ready for the fall vaccination season with ample and timely supply."Ramping up R&D effortsMeanwhile, Moderna's R&D spend during the second quarter jumped to $1.1 billion, up 62% versus the prior-year period, spurred by an increase in development activities for its respiratory syncytial virus (RSV), seasonal influenza and cytomegalovirus (CMV) programmes.Bancel said "our late-stage clinical pipeline is firing on all cylinders with four infectious disease vaccines in Phase III," including the RSV vaccine mRNA-1345, which was submitted to several global regulators last month for use in older adults. The company and partner Merck & Co. also recently announced the start of a Phase III trial testing the individualised neoantigen therapy mRNA-4157/V940 in resected high-risk melanoma, while Moderna's lead rare disease programme mRNA-3927 for propionic acidaemia is in the dose-confirmation stage of an ongoing Phase I/II trial. "We believe that all these products should launch in 2024, 2025 or 2026, and we are continuing to invest in scaling Moderna to bring forward an unprecedented number of innovative mRNA medicines for patients," Bancel said.Moderna has also completed enrolling a Phase III study testing an enhanced formulation of its influenza vaccine candidate mRNA-1010. Earlier this year, it said that while mRNA-1010 was superior against influenza A strains, it fell short against influenza B, although it hopes the updated formulation will generate a better immune response to these strains. An update on the trial dubbed P303 is due in the third quarter.

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