A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

开始日期2023-12-14

申办/合作机构

GSK Plc

NCT05734040

/ Completed临床2期

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

开始日期2023-05-10

申办/合作机构

Osivax SAS

[+2]

CTRI/2022/12/048070

/ Completed临床4期

A single-arm, open-label, multi-center, phase IV trial to evaluate the reactogenicity, safety, and immunogenicity of quadrivalent seasonal influenza vaccine (Fluarix Tetra) in participants aged 65 years and older in India

开始日期2022-12-20

申办/合作机构

GlaxoSmithKline Biologicals SA

[+1]

100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的专利（医药）

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项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Influenza vaccine effectiveness against medically-attended influenza infection in 2023/24 season in Hangzhou, China

Article

作者: Zhao, Shi ; Zhang, Ke ; Yang, Shigui ; Niu, Beidi ; Sun, Zhou ; Liu, Yan ; Wang, Yaojing ; Che, Xinren ; Zhao, Gang ; Wang, Zhe ; Lei, Hao ; Du, Shengqiang

From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024. The VE was estimated using multivariate logistic regression models adjusted for sex, age, influenza detection methods, and influenza testing timing. Of the 157,291 medically-attended ILI participants enrolled 56,704 (36%) tested positive for influenza. Adjusted overall VE against any medically-attended influenza infection was 48% (95% Confidence interval [CI]: 46%-51%). The overall VE of the trivalent inactivated influenza vaccine (IIV3) was 59% (95% CI: 50%-66%), followed by the trivalent live attenuated vaccine (LAIV3) (VE = 53%, 95% CI: 42%-62%) and quadrivalent inactivated influenza vaccine (IIV4) (VE = 47%, 95% CI: 45%-50%). IIV3 provided even better protection against medically-attended influenza B infection than IIV4 (VE = 87%, 95% CI: 81%-92% for IIV3 versus VE = 53%, 95% CI: 50%-57% for IIV4). In the 2023/24 season in Hangzhou, China, the influenza vaccine offered moderate protection during a major epidemic. The results supported the World Health Organization recommendation to exclude the B/Yamagata lineage antigen in quadrivalent influenza vaccines in 2023.

2025-12-31·Human Vaccines & Immunotherapeutics

Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023–24 season

Article

作者: Välimaa, Hanna ; Schelling, Jörg ; Goldstein, Alexander ; Amaral de Avila Machado, Marina ; Vachhani, Parth ; Gallo, Sophie ; Kantele, Anu ; Byrareddy, Reddappa Maniganahally

Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023-24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.

2025-12-31·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3–8 years with or without previous influenza vaccination histories

Article

作者: Liu, Sheng ; Zhu, Fengcai ; Wei, Mingwei ; Wen, Feng ; Zhu, Yinbiao ; Jing, Pengfei ; Shuai, Qi ; Xu, Xinglong ; Zhou, Li ; Li, Jingxin ; Yu, Jun ; Liu, Yan ; Wang, Wenjuan

This study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3-8 years in Pizhou, Jiangsu Province, China. Children with ≥2 doses of prior influenza vaccination (Influenza Vaccination Group) and those with no prior vaccination (Influenza Vaccine-naïve Group) were given two doses of IIV4, 4 weeks apart. The primary immunogenicity endpoints were seroprotection rates (SPRs) of hemagglutination inhibition antibody 28 days after each dose against influenza A/H1N1, A/H3N2, B/Yamagata (BY), and B/Victoria (BV). Safety endpoints included adverse events (AEs) within 28 days and serious adverse events (SAEs) within 6 months. Between September 19-25, 2021, 278 participants were screened, and 240 were enrolled (120 per group). In the Influenza Vaccination Group, SPRs after the 2nd dose were 98.28%, 92.24%, 99.14%, and 87.93%, similar to those after the 1st dose (all p > .05). In the Influenza Vaccine-naïve Group, SPRs after the 2nd dose were 99.12%, 96.49%, 99.12%, and 92.11%, significantly higher than after the 1st dose (p < .001 for all strains except BY, p = .070). Most AEs were mild or moderate, with no serious AEs related to the vaccine. Children aged 3-8 years with prior influenza vaccination need only one dose of IIV4, while those without prior vaccination require two doses. ClinicalTrials.gov, the identifier is NCT05144464.

项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的新闻（医药）

2025-05-21

·BioSpace

Moderna Shares Fall as Combo Flu/COVID-19 Vaccine Application Pulled

iStock, Veronique D After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month. Just two weeks ago, Moderna announced that its combination flu/COVID-19 vaccine outperformed current shots for both diseases. But on Wednesday, the famed biotech withdrew the FDA application for the shot after consultation with the agency. Moderna had filed for a biological license application (BLA) for the vaccine, called mRNA-1083, in late 2024 with an eye toward a late 2025 approval. The company revealed Phase III results in adults 50 years and older in March, before pushing the expected approval date back to 2026 during its Q1 earnings call , citing an expectation for a request for additional data on flu shot efficacy from the FDA. The withdrawal is a setback for Moderna, which had already expected delays for mRNA-1083. In its first quarter earnings report, the company announced that the shot would be deprioritized given “an extended review timeline.” Following news of the withdrawal, Moderna’s shares dropped 4.5% when the markets opened Wednesday, to $26.79 apiece compared to $27.99 at Tuesday’s close. Moderna plans to resubmit the BLA for its combo vaccine, mRNA-1083, later this year when Phase III data from its investigational seasonal flu vaccine, mRNA-1010, become available. Interim data from that trial is expected this summer. mRNA-1083 contains components of mRNA-1010 and components of its second-generation COVID-19 shot, mRNA-1283. Phase III trial data announced earlier this month showed that mRNA-1083 generated as many or more antibodies against most flu strains and the Omicron XBB.1.5 COVID-19 variant in comparison to Moderna’s standalone COVID-19 shot and standard flu shots Fluarix (marketed by GSK for people aged 50 to 64) and Fluzone (from Sanofi for people aged 65 or older, a stronger dose than Fluarix). BioSpace has reached out to Moderna for further comment. The FDA’s regulation of vaccines is in flux. The agency earlier this year missed a deadline for a decision on Novavax’s protein-based COVID-19 vaccine. That vaccine ultimately won approval last week, but only for a subset of older patients and people with underlying conditions. This is largely reflective of new risk-based approval requirements for future COVID-19 candidates introduced Tuesday by FDA Commissioner Marty Makary and CBER Director Vinay Prasad in an editorial published in the New England Journal of Medicine and in an FDA Town Hall. This follows a new requirement announced by the Department of Health and Human Services that all new vaccine trials have a full placebo arm going forward. In a note to investors after the news of HHS’ new requirements, Leerink Partners wrote that “HHS’s judgment appears questionable and risky, in our view.” They added that “placebo-controlled trials are unnecessary and unethical for many populations,” and said “the world will look to other countries’ health authorities as the gold standards for vaccine testing.” Moderna’s main competitor, Pfizer , has submitted applications for two COVID-19 mRNA vaccines for children aged six months to four years and five to 11 years. Pfizer is also conducting a Phase III trial of a shot for children six months to 11 years, as well as a Phase II trial for its own combo flu/COVID-19

临床3期疫苗上市批准信使RNA临床2期

2025-05-08

·生物制品圈

Moderna公司颠覆性新王牌：新冠&流感联合疫苗III期临床结果发布！

由于每年需要分别接种1剂流感疫苗和新冠疫苗，这种接种程序的不便利导致美国两款疫苗的接种率日益下滑。为了解决这一难题、稳住新冠疫苗需求下降导致业绩持续滑坡的风险，mRNA疫苗巨头Moderna公司于昨日在美国医学会杂志（JAMA）上发表了其研发的新冠&流感病毒mRNA联合疫苗的III期临床结果。这项 3 期随机、观察者盲法试验于2023年10月、11 月在美国146个试验点开展，研究对象为≥50岁的成年人，数据提取于2024年4月9日完成。目的是评估在2023~2024年流感季下，研究性mRNA-1083疫苗针对季节性流感病毒和SARS-CoV-2病毒的免疫原性和安全性。为了与美国ACIP推荐的疫苗种类进行平行对照，研究设置了两个对照组：A对照组为50~64岁人群，接种Moderna公司生产的新冠疫苗和GSK生产的四价流感疫苗Fluarix（常规剂量）。B对照组为≥65岁人群，接种Moderna公司生产的新冠疫苗和巴斯德生产的四价流感疫苗Fluzone（高剂量）。主要观察结局目标是证明这款mRNA-1083联合疫苗接种后的体液免疫反应与对照组在第29天对疫苗匹配菌株的非劣效性，并评估mRNA-1083的反应原性和安全性。次要目标包括证明mRNA-1083在第29天相对于对照组引发的体液免疫反应的优越性。免疫反应结果喜人：与两个对照组接种现有疫苗的人群相比，接种联合疫苗的人中针对Covid和两款流感疫苗的3种流感毒株（H1N1/H3N2/BV，除BY型外）的抗体水平更高。简单来说，新疫苗产生的体液抗体水平比现有疫苗高20~40%。安全性可接受：在两个年龄组中，mRNA-1083 疫苗接种后引发的不良反应的频率和严重程度在数值上高于对照组（≥65岁：83.5%vs. 78.1%；50-64岁：85.2%vs. 81.8%）。大多数为严重程度为1级或2级，持续时间短，未发现严重安全问题。联合疫苗能够使人们更容易接种Covid和流感疫苗，特别是因为这两种疫苗通常在秋季接种。一些专家表示，需要一种能提供更好的保护的新疫苗，因为现有的疫苗在阻止感染方面效果不佳。这些数据预计将用于支持 Moderna 向 FDA 申请批准。上周Moderna 表示，预计其联合疫苗要到2026年才会获得监管部门的批准，此前该机构表示需要显示该疫苗对流感的疗效的后期数据。这项研究的价值和市场启发性还在于以下3点：1、当前疫苗犹豫情绪严重，两款疫苗1次注射有助于提高针对两种疾病的接种率。2、当前流感疫苗主要由生产效率较低、成本较高的鸡胚生产，mRNA技术有助于提高生产效率，将革新流感疫苗市场格局。3、如果可行，未来可以在其中加入RSV或人偏肺病毒等抗原，进一步提高针对呼吸道病毒的综合预防能力，彻底改变单一的流感疫苗市场格局。资料来源：Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years. JAMA. Published online May 7, 2025. doi:10.1001/jama.2025.5646

疫苗信使RNA临床3期临床结果

2025-03-01

·生物制品圈

综述|新冠病毒mRNA疫苗的设计与研究进展

导读：由SARS-CoV-2病毒引起的COVID-19疫情对人类健康构成严重威胁。疫苗接种是控制其传播最有效、最经济的干预措施，SARS-CoV-2疫苗现主要有灭活疫苗、重组蛋白亚单位疫苗、mRNA、DNA及VLP疫苗等。其中，mRNA疫苗因开发周期短、易于工业化、响应新变种的灵活性及诱导更好免疫反应的能力等优势而在控制疾病方面发挥重要作用。本期文章菌菌就mRNA疫苗的研究历程、作用机制、SARS-Cov-2病毒结构、新冠疫苗抗原设计及主要产品等总结如下，以期为各类mRNA疫苗的设计提供参考。 01 mRNA疫苗的发现和发展1.1 mRNA疫苗的发展历程随着mRNA递送系统和核酸修饰技术的出现，用于癌症治疗和预防多种传染病的mRNA技术的研究进展迅速。1961年，Brenner及其同事首次描述mRNA分子，由于其高度不稳定性，1969年才使分离的mRNA在体外首次合成蛋白。1984年Krieg及其同事使用SP6 RNA聚合酶在体外成功转录合成mRNA。1987年Malone及其同事利用阳离子脂质封装mRNA以注射到真核细胞，获得体外表达mRNA的高效系统。1990年Wolff及其同事首次将体外转录（IVT）产生的mRNA注射到小鼠股四头肌肌肉中并成功表达。用脂质体包裹的编码流感病毒核蛋白（NP）的mRNA对小鼠进行免疫接种后，在宿主体内诱导产生抗流感CTL，标志着首个mRNA疫苗开发的里程碑。2005年Karikó及其同事发现，使用修饰尿苷合成的mRNA可逃避免疫系统的识别和降解，提高mRNA体内稳定性和免疫原性，开创了mRNA疫苗的新时代。随后，多款mRNA疫苗进入临床开发阶段。在新冠疫情的管理预防中，mRNA疫苗是首批处于临床试验的SARS-CoV-2候选疫苗。截至2022年2月8日，世卫组织报告337种处于开发阶段的SARS-CoV-2候选疫苗，其中47种是mRNA疫苗（23种已进入临床试验）。 mRNA疫苗将编码目标抗原的核酸分子递送到宿主靶细胞中进行表达引发免疫反应。当携带抗原的病原体入侵时，宿主的免疫系统迅速触发体液和细胞免疫反应。1.2 mRNA疫苗的作用机制 Th1细胞反应 mRNA-1273、BNT162b2等mRNA疫苗及其他SARS-CoV-2疫苗可诱导Th1细胞反应。分布在外周淋巴器官的CD4+ T细胞在识别AP-MHC II类复合物和T细胞受体（TCR）后分化为Th1细胞，其可分泌白细胞介素2（IL-2）等多种细胞因子，同时上调相关受体（IL-2R）表达，IL-2与IL-2R结合后，促进T细胞增殖和CD8+ T细胞活化。活化的CD8+ T细胞分化成CTL，进一步诱导细胞免疫。当效应细胞（Th细胞和CTL）清除抗原时，T细胞反应减弱，免疫系统恢复稳态。此外，Th1细胞可分泌IFN-γ和TNF-α，前者诱导CD4+ T细胞分化并增强免疫反应强度。图1 疫苗诱导的Th1细胞反应生发中心反应和体液免疫调节除T细胞反应外，mRNA疫苗诱导的滤泡辅助性T细胞（Tfh细胞）还可触发有效的SARS-CoV-2抗原特异性生发中心B细胞（GC B细胞）反应。一些活化的Th细胞可移动到淋巴滤泡分化为Tfh细胞。活化的B细胞在淋巴滤泡中增殖、分裂，形成生发中心，在Tfh细胞帮助下，GC B细胞的抗体基因可变区发生高频点突变，抗体类别实现转化，最终形成记忆B细胞和浆细胞，产生高亲和力抗体。研究表明BALB/c小鼠的GC B细胞反应在注射基于全长S蛋白的mRNA疫苗后7-14天达到峰值。 GC B细胞的持续存在是诱导长寿命浆细胞的前提，持续性GC B细胞反应可分泌强效、持久的中和抗体，并引发强大的体液免疫。图2 疫苗诱导的生发中心反应记忆细胞反应疫苗诱导的记忆细胞反应可诱导Th1和持续的生发中心反应，从而触发强大的细胞和体液免疫。该过程形成的抗原特异性记忆T细胞和B细胞对长期保护具重要意义。与初始T细胞活化不同，记忆T细胞的激活不再依赖抗原呈递细胞，且可诱导更强的免疫反应。大多数记忆B细胞进入血液参与循环，遇到相同抗原时被迅速激活产生有效抗体。此外，在COVID-19康复患者和单剂接种mRNA疫苗的正常群体中都可检测到记忆细胞的存在。图3 疫苗诱导的记忆细胞反应 02 SARS-CoV-2病毒结构 SARS-CoV-2是一种单链正义RNA包膜病毒，属冠状病毒科β冠状病毒属。SARS-CoV-2分离株Wuhan-Hu-1全长基因组含29881个核苷酸，编码16种非结构蛋白（nsp）、9种辅助蛋白和4种结构蛋白，4种结构蛋白包括刺突蛋白(S)、包膜蛋白(E)、膜蛋白(M)和核衣壳蛋白(N)。 N蛋白位于衣壳内，通过将病毒RNA包裹成核糖核蛋白复合物来保护病毒RNA基因组，并执行包括病毒RNA复制和转录在内的多种功能。M蛋白在病毒表面大量存在，因其膜的弯曲特性负责病毒融合、组装和出芽功能。E蛋白负责病毒粒子组装、形态发生与致病。S蛋白是存在于病毒粒子外膜上的跨膜结构蛋白，通过与宿主细胞表面的特异性受体接触，促进病毒进入宿主细胞。图4 SARS-CoV-2病毒结构 03 SARS-CoV-2 mRNA疫苗的抗原设计 SARS-CoV-2表面的三聚体S蛋白在介导宿主细胞侵袭中起关键作用，被认为是疫苗设计的主要抗原。在病毒感染过程中，S蛋白被Furin酶和TMPRSS2裂解为S1和S2亚基。S1亚基含信号肽（SP）、RBD、N端结构域（NTD）、CTD1和CTD2，主要通过RBD与血管紧张素转化酶2（ACE2）受体相互作用。S2亚基包括融合肽（FP）、双七肽重复序列（HR）、中心螺旋区（CH）、连接结构域（CD）、跨膜结构域（TMD）和细胞质尾部（CT），负责介导病毒与宿主细胞膜间的融合。RBD和ACE2受体在宿主细胞膜上结合后，S蛋白发生结构重排，形成融合后构象。研究发现，S蛋白预融合构象具良好免疫原性，被认为是理想的目标抗原，大多数中和抗体是基于S蛋白在融合前构象的表位塑造的，一旦S蛋白获得融合后构象，该表位被覆盖并减少中和抗体的产生。图5 SARS-CoV-2 mRNA疫苗设计策略的基本原理设计SARS-CoV-2 S蛋白常采用两种策略：（1）2P突变策略：S2亚基中心螺旋位置顶部的两个氨基酸被脯氨酸（K986P和V987P）取代，可有效提高S蛋白在预融合构象中的稳定性。该策略适用于SARS-CoV-2和其他β冠状病毒，BioNTech、Moderna、CureVac等均采用该策略。（2）S1/S2切割位点策略：直接将野生型SARS-CoV-2蛋白S中的Q677TNSPRRARYSV687序列删除至Q677TILRYSV683或氨基酸突变（RRAR到GGSG），阻止S蛋白在宿主细胞中切割，保持其结构稳定性并诱导更强的免疫应答。某些研究机构已开发出优化S蛋白的独特策略，如删除S2亚基上的TMD、CT、FP并突变S2′切割位点（K814A、R815N），提高预融合S蛋白的构象稳定性。在某些情况下，可在ORF区域的前段插入额外的序列，增加抗原蛋白的表达。此外，由于S蛋白是三聚体，在S蛋白或RBD蛋白编码区3'端引入T4噬菌体纤维蛋白的三聚体基序可模拟S蛋白的天然结构并增强抗原免疫原性。研究表明当选择不同的信号肽时，目标抗原的蛋白质表达水平存在显着差异，其中S蛋白信号肽MFVFLVLLPLVSSQCV已被包括BioNTech和Moderna在内的多家开发商用于SARS-CoV-2 mRNA疫苗；RiboBio在SARS-CoV-2 mRNA疫苗中采用免疫球蛋白重链可变区（IGVH）信号肽序列（MDWIWRILFLVGAATGAHS）来增加目标蛋白表达。综上，由于mRNA疫苗涉及序列编辑，可对S蛋白的结构、稳定性和表达进行修饰改善空间构象，从而提高疫苗诱导的免疫应答。表1 SARS-CoV-2 mRNA疫苗抗原设计策略 04 上市/在研的新冠mRNA疫苗4.1 主要上市产品 BNT162b2：BioNTech和Pfizer合作开发的5种SARS-CoV-2 mRNA候选疫苗分别为基于核苷修饰的mRNA（BNT162b2、BNT162b1、BNT162b3）、未修饰的mRNA（BNT162a1）和自扩增mRNA（BNT162c2）。其中BNT162b2编码全长刺突糖蛋白，S2亚基中具两个脯氨酸突变以维持蛋白质的融合前构象；BNT162b1编码分泌形式的三聚体刺突蛋白RBD。BNT162b2于2020年12月11日获得美国政府的紧急使用授权（EUA），并于2021年8月获得FDA的生物制品许可证申请批准（BLA），成为全球首个上市的用于治疗COVID-19的mRNA疫苗。 mRNA-1273：Moderna开发的mRNA-1273编码SARS-CoV-2的全长预融合刺突蛋白，具良好耐受性，是美国政府于2020年12月18日获得EUA的第二种mRNA疫苗，2022年2月1日正式获FDA的生物制品许可证申请批准上市‌。Moderna成功推出的另外2款新冠疫苗为针对原始株及Omicron BA.1的二价疫苗（mRNA-1273.214）和针对Omicron BA.4/BA.5的二价疫苗（mRNA-1273.222）。 ARCT-154：由CSL与Arcturus therapeutics联合开发的首款上市的saRNA疫苗，已获日本厚生劳动省（PMDA）批准上市。ARCT-154抗原编码基因为SARS-Cov-2 S蛋白D614G突变序列，复制酶来自VEEV非结构蛋白编码序列nsp1-4。 SYS6006：石药集团于2023年3月22日宣告其研发的mRNA新冠疫苗（SYS6006）在中国纳入紧急使用，用于预防COVID-19，SYS6006是涵盖Omicron BA.5突变株核心突变位点的mRNA疫苗，于2022年4月获得国家药监局的应急批准进行临床试验，已在中国完成Ⅰ、Ⅱ期和序贯加强免疫临床研究，结果证明了其安全性、免疫原性和保护效力。4.2 其他上市/在研产品 PF-07252220：由Pfizer和BioNTech合作研发的主要用于预防流感和流感/COVID-19组合疫苗，已发布的III期试验结果表明在18-64岁患者中疗效优于已上市的流感疫苗。而针对流感/COVID-19的联合mRNA疫苗仅达到一项免疫原性治疗终点的结果。 mRNA-1083：由Moderna研发的COVID-19/流感疫苗（mRNA-1083）由流感疫苗mRNA-1010和下一代新冠疫苗mRNA-1283组成。mRNA-1083的III期研究在2个独立的年龄队列中评估免疫原性、安全性和反应原性：65岁及以上组，mRNA-1083与赛诺菲的高剂量流感疫苗Fluzone及Moderna的Spikevax进行比较；50-65岁组，与GSK的Fluarix及Moderna的Spikevax进行比较。结果mRNA-1283显示出对照组的非劣效性，并引发对3种流感病毒株（H1N1、H3N2和B/Victoria）及SARS-CoV-2更显著的免疫反应。且Moderna成为首家及唯一公布COVID-19/流感联合疫苗III期阳性结果的公司。 GSK4382276和GSK4388067：GSK购买了CureVac公司针对COVID-19（GSK4388067）和流感（GSK4382276）mRNA疫苗的全球开发权，并可选择开发针对禽流感的组合疫苗和附加疫苗。GSK4388067和GSK4382276目前都处于II期试验中。 ABO1020：继艾博生物与沃森生物、中国军科院共同研发的新冠mRNA疫苗ARCoVax（编码SARS-CoV-2的RBD）于2020年6月成为国内首个获批开展临床试验的新冠mRNA疫苗后。2024年7月，Cell出版社医学旗舰刊Med发表艾博生物新冠变异株（BA.4/5）mRNA疫苗（ABO1020）的III期保护力临床数据，采用随机、双盲、安慰剂对照设计，评价在既往接种2剂或3剂新冠灭活疫苗人群中接种2剂ABO1020的疫苗效力、免疫原性和安全性，并达到预期评价目的和标准。同时基于体液免疫评价结果和免疫机制，阐明针对国内主流的2剂新冠灭活疫苗建立的免疫保护相对弱的实际情况，通过首次接种2剂mRNA疫苗，可突破免疫印迹，面对新的突变株提供有效的交叉保护。 SW-BIC-213：由“国产mRNA疫苗三剑客”之一的斯微生物自主研发的新冠mRNA疫苗，在老挝完成Ⅲ期临床并达到主要研究终点，该疫苗在研发设计中包含了Delta、Omicron等多种新冠病毒变异株均有的D614G突变，对新冠病毒流行株具保护效力，有一定广谱性。‌‌ 05 结语与传统疫苗不同，mRNA疫苗可调整抗原设计，甚至允许组合来自多个变体的序列以响应病毒基因组中的新突变。目前mRNA疫苗所赋予的安全性和保护性是令人满意的，但长期保护作用需进一步临床研究确定。参考文献 [1] Fang E, Liu X, Li M, et al. Advances in COVID-19 mRNA vaccine development[J]. Signal transduction and targeted therapy, 2022, 7(1): 94. [2] Li M, Wang H, Tian L, et al. COVID-19 vaccine development: milestones, lessons and prospects[J]. Signal transduction and targeted therapy, 2022, 7(1): 146. 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不本站。

信使RNA疫苗免疫疗法

100 项与 Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
流感病毒感染	澳大利亚	GSK Plc	2013-08-28
甲型流感病毒感染	美国	GlaxoSmithKline LLC	2005-08-31
甲型流感病毒感染	美国	GlaxoSmithKline Biologicals SA	2005-08-31
乙型流感病毒感染	美国	GlaxoSmithKline Biologicals SA	2005-08-31
乙型流感病毒感染	美国	GlaxoSmithKline LLC	2005-08-31

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
新型冠状病毒感染	临床3期	美国	GSK Plc	2021-10-07
呼吸道合胞体病毒感染	临床3期	新西兰	GSK Plc	2021-04-27
呼吸道合胞体病毒感染	临床3期	巴拿马	GSK Plc	2021-04-27
呼吸道合胞体病毒感染	临床3期	南非	GSK Plc	2021-04-27
带状疱疹	临床3期	美国	GSK Plc	2013-10-03
带状疱疹	临床3期	加拿大	GSK Plc	2013-10-03
带状疱疹	临床3期	德国	GSK Plc	2013-10-03
白喉	临床3期	美国	GSK Plc	2006-10-23
破伤风	临床3期	美国	GSK Plc	2006-10-23
百日咳	临床3期	美国	GSK Plc	2006-10-23

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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


NCT05648357 (CTgov)	临床4期	流感病毒感染	250	Fluarix Tetra Vaccine	餘鑰選壓繭夢繭簾顧網 = 膚鏇糧獵夢範襯糧壓鏇簾選願膚糧鹽顧鹽選鹽 (糧壓鏇鹹壓構範鬱構積, 簾鹽憲糧鏇簾鏇鬱壓廠 ~ 鑰膚廠積網鬱廠淵網窪) 更多	-	2025-03-28
NCT05047770 (Pubmed) 人工标引	临床3期	带状疱疹	497	mRNA-1273quFlu D-QIVt influenza vaccine (QIV)	顧壓製積齋蓋觸廠繭網(膚願醖廠製網製鬱淵鬱) = The most frequently reported adverse events in both groups were pain at the injection site and myalgia. 艱積積衊膚簾積願憲憲 (範簾顧選憲糧鹹選顧繭 ) 更多	非劣	2024-12-31
				mRNA-1273 + Flu D-QIV(CoAd )
NCT03722589 (CTgov)	临床4期	流感病毒感染	944	Flublok (Flublok (Recombinant))	鹹襯艱願遞網醖糧襯蓋 = 構醖鏇糧醖繭選憲觸蓋窪壓網鹹網範鑰齋獵遞 (鑰願網觸鏇窪廠遞網繭, 繭窪願壓餘網築廠鑰膚 ~ 築顧壓選製齋膚鏇鑰製) 更多	-	2024-07-22
				Flucelvax (Flucelvax (Cell-based))	鹹襯艱願遞網醖糧襯蓋 = 壓選製繭鑰選築網糧鹹窪壓網鹹網範鑰齋獵遞 (鑰願網觸鏇窪廠遞網繭, 齋構憲衊壓獵夢製積網 ~ 衊壓製簾衊廠壓餘餘壓) 更多
NCT05047770 (CTgov)	临床3期	新型冠状病毒感染 \| 带状疱疹 \| 流感病毒感染	2,013	mRNA-1273+HZ/su (HZ/suSeq Group)	憲壓夢艱簾簾鹹觸積積(築積觸鹹蓋築繭夢蓋範) = 築遞簾觸遞築窪艱願築餘觸製鑰齋製鬱觸艱遞 (鹹壓淵憲觸襯遞膚繭壓, 衊壓夢範築願遞艱齋糧 ~ 鏇淵壓製鹽膚顧餘簾壓) 更多	-	2023-11-13
				mRNA-1273+HZ/su (HZ/suCoAd Group)	憲壓夢艱簾簾鹹觸積積(築積觸鹹蓋築繭夢蓋範) = 築範鬱築鹹鑰憲壓築餘餘觸製鑰齋製鬱觸艱遞 (鹹壓淵憲觸襯遞膚繭壓, 簾鹽憲顧選憲衊窪壓襯 ~ 蓋簾選網鏇範蓋製觸選) 更多
NCT04841577 (CTgov)	临床3期	呼吸道合胞体病毒感染 \| 流感病毒感染	976	FLU-QIV+RSVPreF3 OA investigational vaccine (Co-Ad Group)	顧餘夢獵繭襯膚鑰築糧(窪夢壓繭鏇簾獵築網醖) = 憲蓋選願壓鏇鏇糧蓋衊鹽淵齋構鏇鹹醖構淵構 (鬱糧窪顧醖糧願壓簾襯, 窪窪獵餘夢構鑰觸獵衊 ~ 醖夢鬱糧選膚淵鏇願簾) 更多	-	2022-10-18
				FLU-QIV+RSVPreF3 OA investigational vaccine (Control Group)	顧餘夢獵繭襯膚鑰築糧(窪夢壓繭鏇簾獵築網醖) = 衊壓鹽鬱廠選構獵壓選鹽淵齋構鏇鹹醖構淵構 (鬱糧窪顧醖糧願壓簾襯, 衊顧簾衊鹹築壓衊淵獵 ~ 艱壓壓顧獵遞範築夢築) 更多
NCT03686514 (FLU2, CTgov)	临床4期	流感病毒感染	39	seasonal influenza vaccine (H3N2 Birth Cohort, Born Between 1968 and 1977)	襯蓋鹹繭獵簾築範觸鏇 = 網艱鹹顧齋積憲鹽廠簾餘憲範繭衊窪觸獵遞網 (鏇鹹窪壓製選製壓齋鏇, 願選繭鬱獵築範簾鹽繭 ~ 築衊製蓋觸願鬱衊鏇繭) 更多	-	2022-07-13
				seasonal influenza vaccine (H1N1 Birth Cohort, Born Between 1948 and 1957)	襯蓋鹹繭獵簾築範觸鏇 = 憲簾繭遞積獵醖積獵衊餘憲範繭衊窪觸獵遞網 (鏇鹹窪壓製選製壓齋鏇, 窪艱構憲鬱製繭獵鏇衊 ~ 艱選積醖繭鬱夢衊齋壓) 更多
NCT03165981 (CTgov)	临床4期	热性惊厥 \| 发热 \| 接种疫苗	221	IIV+DTaP+PCV13 (Simultaneous Vaccination Arm)	襯築膚艱膚艱廠遞糧襯 = 膚艱鏇襯製網築襯糧窪襯鏇廠鹹鹹艱鏇艱鬱窪 (壓鹹構淵繭膚膚蓋蓋構, 鏇獵繭製膚糧壓選鹽淵 ~ 簾淵艱構窪鹹範窪顧構) 更多	-	2019-02-08
				IIV+DTaP+PCV13 (Sequential Vaccination Arm)	襯築膚艱膚艱廠遞糧襯 = 範襯淵艱廠網艱願築醖襯鏇廠鹹鹹艱鏇艱鬱窪 (壓鹹構淵繭膚膚蓋蓋構, 醖築獵鑰蓋鏇觸憲蓋鏇 ~ 鬱艱觸簾網夢獵衊醖繭) 更多
NCT00385255 (CTgov)	临床3期	白喉 \| 百日咳 \| 破伤风 ... 更多	1,726	Fluarix®+Boostrix® (Boostrix+Fluarix Group)	憲積構獵願製鹹壓築製(膚積選願鑰鑰餘齋選獵) = 顧鬱餘夢積壓鹹範鏇製蓋襯鹹繭願糧糧鏇網遞 (壓遞艱鹹糧構艱廠廠餘, 窪積艱顧齋夢窪蓋積鬱 ~ 憲顧遞醖鬱網鏇鑰艱製) 更多	-	2018-09-17
				Fluarix®+Boostrix® (Fluarix Boostrix Group)	憲積構獵願製鹹壓築製(膚積選願鑰鑰餘齋選獵) = 繭構顧選構構鹽醖鬱淵蓋襯鹹繭願糧糧鏇網遞 (壓遞艱鹹糧構艱廠廠餘, 築壓鬱齋鑰繭艱選築餘 ~ 範膚簾壓蓋範壓鹽衊鑰) 更多
NCT00318149 (CTgov)	临床2期	流感病毒感染	425	Fluarix (Fluarix 18-40 Y Group)	鹽艱遞鹽齋範衊齋築鬱(齋範獵艱窪膚鏇鹹觸醖) = 窪鑰廠夢鏇壓鏇憲艱鏇築範獵窪積鹹蓋襯憲鹹 (艱顧窪淵獵壓遞淵網繭, 1643.2) 更多	-	2018-08-08
				Fluarix (Fluarix ≥65 Y Group)	鹽艱遞鹽齋範衊齋築鬱(齋範獵艱窪膚鏇鹹觸醖) = 鹽鬱壓鬱廠簾積夢淵鬱築範獵窪積鹹蓋襯憲鹹 (艱顧窪淵獵壓遞淵網繭, 1557.22) 更多