A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age

The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.

开始日期2025-08-05

申办/合作机构

ModernaTX, Inc.

NCT06143046

/ Active, not recruiting临床2期

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

开始日期2023-11-15

申办/合作机构

ModernaTX, Inc.

NCT06097299

/ Completed临床2期

A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Disease

Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3).
Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.

开始日期2023-10-24

申办/合作机构

ModernaTX, Inc.

100 项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的临床结果

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100 项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的转化医学

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100 项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的专利（医药）

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项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Post-marketing safety monitoring of RSV vaccines: A real-world study based on the Vaccine Adverse Event Reporting System (VAERS)

Article

作者: Gao, Weixi ; Chai, Liqing ; Liu, Yuxiang ; Bao, Zhuocheng ; Yu, Xiao

Two protein subunit vaccines - RSVPreF3 (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer) - and one mRNA RSV vaccine, mRNA-1345 (mRESVIA, Moderna), have been approved. Post-marketing surveillance is crucial for evaluating the safety of RSV vaccines. We reviewed VAERS reports on RSV vaccines, using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) to identify safety signals. Our analysis incorporated severity, time-to-onset, subgroup, and sensitivity analyses to enhance key findings. After analyzing 5,147 RSVPreF3, 2,734 RSVpreF, and 35 mRNA-1345 reports, 91, 103, and 8 positive PT signals were found, respectively. Among serious reports, both RSVPreF3 and RSVpreF were associated with 9 important medical events (IMEs), including immune thrombocytopenia, which was also classified as a designated medical event (DME). Three pregnancy-related IME signals-hemorrhage in pregnancy, fetal death, and fetal hypokinesia - were reported for RSVpreF. Descriptive analysis of time-to-onset complemented the overall safety profiling, and sensitivity analysis offered further support for the observed disproportional reporting trends in certain adverse events (AEs). Our study utilized real-world data from large-scale spontaneous reporting systems to detect AEs that were disproportionately reported following RSV vaccination, thereby generating early safety signals to inform hypothesis development and support clinical awareness.

2025-12-31·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12–59 months

Article

作者: Guo, Ruiting ; Morsy, Louie ; Fanning, Sue ; Stoszek, Sonia K. ; Dhar, Rakesh ; El Asmar, Laila ; Snape, Matthew D. ; Eder, Frank ; Essink, Brandon ; Schnyder Ghamloush, Sabine ; Shaw, Christine A. ; Kapoor, Archana ; Righi, Vinicius

Respiratory syncytial virus (RSV) is a common respiratory pathogen in children. After demonstrating safety and immunogenicity in adults, mRNA-1345 encoding the RSV prefusion (preF) stabilized F glycoprotein was investigated in children. This phase 1, randomized, observer-blind study assessed the safety and immunogenicity of mRNA-1345 (NCT04528719) in RSV-seropositive children (per microneutralization assay) aged 12-59 months and is part of a larger study in multiple populations. Participants received three doses of mRNA-1345 (15 μg or 30 μg) or placebo 56 days apart, with 12-month safety follow-up. Forty-six participants were randomized to receive mRNA-1345 15 μg (n = 15), mRNA-1345 30 μg (n = 16), or placebo (n = 15). mRNA-1345 was well tolerated at both dose levels. The most frequently reported solicited local adverse reaction (AR) was injection site tenderness (15 μg, 27.3%-50.0%; 30 μg, 53.3%-71.4%; placebo, 26.7%-33.3%). Most solicited systemic ARs were grade 1/2, with irritability/crying, loss of appetite, and sleepiness most frequently reported; reactogenicity did not increase with additional doses. Throughout the 12-month follow-up, no serious adverse events (AEs), deaths, AEs of special interest, or AEs leading to study discontinuation were reported. Three medically attended RSV infections were reported among placebo recipients. A single injection increased RSV-A and RSV-B neutralizing antibody titers (geometric mean fold rise [GMFR] over baseline: 15 μg, RSV-A = 18.9, RSV-B = 7.2; 30 μg, RSV-A = 34.9, RSV-B = 14.3) and RSV preF and postF binding antibody concentrations (GMFR: 15 μg, preF = 13.9, postF = 9.3; 30 μg, preF = 26.5, postF = 16.0); binding antibody responses were preF-biased. Subsequent doses did not further increase antibody levels. In conclusion, mRNA-1345 was well tolerated and boosted antibody levels in seropositive children aged 12-59 months.

2025-09-01·VACCINE

Design and preclinical assessment of mRNA-1345 prefusion F glycoprotein-encoding mRNA vaccine for respiratory syncytial virus

Article

作者: Jorquera, Patricia ; Hunter, Naila ; Reid, David W ; Hanahoe, Erin ; Presnyak, Vlad ; Ma, LingZhi ; Carfi, Andrea ; Elbashir, Sayda ; Shaw, Christine A ; Ong, Edison ; Rabideau, Amy E ; Stewart-Jones, Guillaume B E ; Ketova, Tatiana ; Woods, Angela ; Narayanan, Elisabeth ; Mani, Sachin ; Mihai, Cosmin ; Kaplonek, Paulina

Respiratory syncytial virus (RSV) is a significant cause of lower respiratory tract disease in young children and older adults. We designed a codon-optimized mRNA vaccine, mRNA-1345, encoding the RSV F-glycoprotein stabilized in the prefusion (preF) conformation and with a deletion at the cytoplasmic tail. mRNA-1345 cell surface protein expression was higher and detected for longer versus previous mRNA-based RSV vaccine candidates evaluated clinically. In rodent models, mRNA-1345 induced a robust neutralizing and preF-biased antibody response, a T helper 1-biased cellular response, and demonstrated dose-dependent protection against RSV challenge with no evidence of enhanced respiratory disease. These results supported initial clinical evaluation of mRNA-1345 in adults, children, and RSV-naïve infants; mRNA-1345 was recently demonstrated to be efficacious against RSV disease in older adults in a pivotal efficacy study.

351

项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的新闻（医药）

2025-09-02

·细胞基因治疗前沿

中美双报双批，嘉译生物RSV mRNA疫苗国内获批临床

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 2025年8月28日，嘉译生物医药（杭州）有限公司自主研发和申报的呼吸道合胞病毒（RSV） mRNA疫苗(NT-INF-001)正式获得国家药品监督管理局药品审评中心（CDE）核准签发的《药物临床试验批准通知书》。值得注意的是，该疫苗已于2024年12月获得美国FDA的临床试验许可，且在美国FDA疫苗与相关生物制品咨询委员会（VRBPAC）专门针对婴幼儿RSV疫苗安全性召开公开会议后一周内，以"零技术问询"的优异表现快速获得批准。图源：CDE官网此次NT-INF-001在中国获批临床，标志着该产品成功实现"中美双报双批"的重要里程碑，不仅证明了疫苗本身卓越的产品质量、可靠的安全性和良好的有效性，更充分展现了嘉译生物在mRNA药物设计、工艺开发和注册申报等方面的综合实力与国际水准。这一成就也为公司后续推进下一代mRNA产品管线、加速布局差异化创新疫苗奠定了坚实基础。关于呼吸道合胞病毒（RSV）和 NT-INF-001疫苗 RSV是一种具有多个亚型和高传染性的呼吸道病原体，对老年人、婴幼儿和免疫功能低下人群的危害尤为显著。接种预防性疫苗进行主动免疫，是预防RSV重症感染和减少死亡的关键手段。在经历了数十年研发探索后，2023至2024年间，终于迎来了全球三款RSV疫苗获批上市，包括GSK的AREXVY、Pfizer的ABRYSVO和Moderna的mRESVIA。其中GSK和Pfizer的疫苗在2024年销售收入已达15.1亿美元，显示出巨大的市场需求和临床价值。随着全球人口老龄化加剧和婴幼儿健康重视度提升，RSV疫苗领域仍存在广阔的未满足医疗需求和发展空间。 NT-INF-001是嘉译生物基于自主知识产权的mRNA平台技术开发的一款创新型RSV mRNA疫苗。该疫苗采用当前流行病毒株构建核心抗原，并结合AI赋能的密码子优化技术，显著提升了抗原蛋白的表达效率与免疫原性。非临床研究数据显示，NT-INF-001展现出优异的融合前构象稳定性，可诱导广泛而持久的交叉免疫保护，并表现出良好的安全性特征。在与已上市疫苗AREXVY和ABRYSVO的头对头对比研究中，NT-INF-001在诱导中和抗体水平和细胞免疫应答方面均显示出显著优势，且未观察到免疫失衡风险。进一步的系统评估证实，NT-INF-001在体液免疫和细胞免疫反应特征及肺组织病理学变化方面，均表明其诱发疫苗相关增强性呼吸道疾病（VAERD）的潜在风险极低，展现出全面竞争优势。文章来源：嘉译生物

疫苗信使RNA上市批准临床研究

2025-08-30

·药时空

中美双报双批：嘉译生物RSV mRNA疫苗成功获得CDE药物临床试验批准

2025年8月28日，嘉译生物医药（杭州）有限公司自主研发和申报的呼吸道合胞病毒（RSV） mRNA疫苗(NT-INF-001)正式获得国家药品监督管理局药品审评中心（CDE）核准签发的《药物临床试验批准通知书》。值得注意的是，该疫苗已于2024年12月获得美国FDA的临床试验许可，且在美国FDA疫苗与相关生物制品咨询委员会（VRBPAC）专门针对婴幼儿RSV疫苗安全性召开公开会议后一周内，以"零技术问询"的优异表现快速获得批准。图源：CDE官网此次NT-INF-001在中国获批临床，标志着该产品成功实现"中美双报双批"的重要里程碑，不仅证明了疫苗本身卓越的产品质量、可靠的安全性和良好的有效性，更充分展现了嘉译生物在mRNA药物设计、工艺开发和注册申报等方面的综合实力与国际水准。这一成就也为公司后续推进下一代mRNA产品管线、加速布局差异化创新疫苗奠定了坚实基础。关于呼吸道合胞病毒（RSV）和 NT-INF-001疫苗 RSV是一种具有多个亚型和高传染性的呼吸道病原体，对老年人、婴幼儿和免疫功能低下人群的危害尤为显著。接种预防性疫苗进行主动免疫，是预防RSV重症感染和减少死亡的关键手段。在经历了数十年研发探索后，2023至2024年间，终于迎来了全球三款RSV疫苗获批上市，包括GSK的AREXVY、Pfizer的ABRYSVO和Moderna的mRESVIA。其中GSK和Pfizer的疫苗在2024年销售收入已达15.1亿美元，显示出巨大的市场需求和临床价值。随着全球人口老龄化加剧和婴幼儿健康重视度提升，RSV疫苗领域仍存在广阔的未满足医疗需求和发展空间。 NT-INF-001是嘉译生物基于自主知识产权的mRNA平台技术开发的一款创新型RSV mRNA疫苗。该疫苗采用当前流行病毒株构建核心抗原，并结合AI赋能的密码子优化技术，显著提升了抗原蛋白的表达效率与免疫原性。非临床研究数据显示，NT-INF-001展现出优异的融合前构象稳定性，可诱导广泛而持久的交叉免疫保护，并表现出良好的安全性特征。在与已上市疫苗AREXVY和ABRYSVO的头对头对比研究中，NT-INF-001在诱导中和抗体水平和细胞免疫应答方面均显示出显著优势，且未观察到免疫失衡风险。进一步的系统评估证实，NT-INF-001在体液免疫和细胞免疫反应特征及肺组织病理学变化方面，均表明其诱发疫苗相关增强性呼吸道疾病（VAERD）的潜在风险极低，展现出全面竞争优势。关于嘉译生物嘉译生物成立于2021年11月，总部位于杭州市滨江区。公司专注于利用前沿mRNA和抗体技术平台，开发针对感染免疫性疾病和肿瘤等领域的创新生物药物，致力于为全球患者提供优质的治疗选择。公司核心团队成员均拥有20年以上在国际知名大学、科研机构和跨国制药企业的工作经验，曾成功主导多个生物医药产品的研发、生产、IND和BLA申报。目前，公司多条mRNA药物和抗体管线已完成概念验证，相关开发、生产及国内外申报工作正在有序推进。与此同时，公司已与国内外多家生物制药企业和科研机构建立战略合作关系，共同探索mRNA和抗体技术在更广泛预防和治疗领域的应用潜力。在追求产品创新和市场成功的同时，嘉译生物高度重视企业文化建设，积极倡导开拓创新、团结协作和持续进步的发展理念。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

信使RNA疫苗上市批准临床申请

2025-08-29

·同写意

双报双批！楷拓助力嘉译RSV mRNA疫苗获CDE临床批件丨会员动态

信使RNA疫苗临床申请上市批准核酸药物

100 项与 Respiratory Syncytial Virus Vaccine(Moderna) 相关的药物交易

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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
呼吸道合胞体病毒感染	美国	ModernaTX, Inc.	2024-05-31

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
流感病毒感染	临床3期	美国	ModernaTX, Inc.	2022-04-01
严重急性呼吸综合征	临床3期	美国	ModernaTX, Inc.	2022-04-01
人类偏肺病毒感染	临床1期	美国	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	澳大利亚	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	加拿大	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	巴拿马	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	波兰	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	南非	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	西班牙	ModernaTX, Inc.	2023-02-15
人类偏肺病毒感染	临床1期	英国	ModernaTX, Inc.	2023-02-15

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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


NCT06060457 (CTgov)	临床3期	呼吸道合胞体病毒感染 \| 流感病毒感染	1,900	Fluzone HD+mRNA-1345 (Fluzone HD + mRNA-1345 Followed by Placebo)	選窪遞襯蓋顧鏇衊膚獵 = 範觸蓋遞餘獵獵艱獵蓋憲築獵衊繭憲膚壓構蓋 (廠繭積製廠選廠膚憲鑰, 艱顧選廠淵衊顧艱鏇構 ~ 鑰艱繭鑰鏇衊窪築遞膚) 更多	-	2025-07-30
				Fluzone HD+mRNA-1345 (Fluzone HD + Placebo Followed by mRNA-1345)	選窪遞襯蓋顧鏇衊膚獵 = 顧窪醖遞繭顧獵築繭鏇憲築獵衊繭憲膚壓構蓋 (廠繭積製廠選廠膚憲鑰, 醖窪鬱築憲繭網鏇壓繭 ~ 淵淵蓋淵鬱醖鹽網願遞) 更多
NCT05127434 (ConquerRSV, Pubmed \| J Infect Dis)	临床2/3期	-	-	mRNA-1345 RSV Vaccine (mRNA-1345 50-µg)	積壓衊壓構鹹蓋選願築(壓選廠淵願繭繭繭夢衊) = 艱艱廠網鏇鬱鬱網衊鑰淵觸遞糧醖廠蓋淵網襯 (構夢膚構顧蓋鑰鹹夢遞 ) 更多	积极	2024-11-15
NCT04528719 (Pubmed)	临床1期	呼吸道合胞体病毒感染	25	mRNA-1345	積簾襯壓築壓築選繭獵(憲簾醖醖鹽憲壓網顧獵) = 鬱鬱製糧壓鹽蓋餘顧範齋膚繭糧遞夢窪製餘獵 (膚壓獵積鹽窪壓糧壓憲 ) 更多	积极	2024-09-09
				安慰剂	-
NCT05127434 (Pubmed 1 \| Pubmed 2 \| N Engl J Med) 人工标引	临床2/3期	呼吸道合胞体病毒感染	35,541	mRNA-1345	鏇蓋憲簾糧窪網餘製構(鏇窪鹽網餘獵積蓋網繭) = 築構膚構餘顧顧獵獵廠鬱網範觸獵醖餘衊積顧 (壓構廠壓蓋醖鏇構鬱襯, 66.0 ~ 92.2) 更多	积极	2023-12-14
				Placebo	選膚憲鏇鑰願積築獵夢(夢網壓憲夢餘壓構膚淵) = 衊獵膚鹽繭鑰顧鏇遞簾膚鏇糧蓋壓鹽襯鏇鬱醖 (範鬱夢願願齋醖衊觸鹹 )
NCT05127434 (ConquerRSV, Biospace) 人工标引	临床3期	呼吸道合胞体病毒感染	37,000	mRNA-1345	鏇範製構鑰製憲製衊選(蓋鏇製淵淵繭窪獵鏇廠) = 製廠鑰觸築艱範觸觸範製廠選鹽鏇艱醖獵選簾 (遞襯窪齋願壓廠構餘蓋, 66.1 ~ 92.2) 更多	积极	2023-08-03
NCT05127434 (Accesswire) 人工标引	临床3期	呼吸道合胞体病毒感染	37,000	mRNA-1345	簾窪餘鑰鬱鹽餘選鹹選(選獵窪膚壓顧構夢築蓋) = 獵顧築壓廠鑰範遞膚憲廠艱願廠範餘憲構糧餘 (繭艱構網糧製製積獵艱 ) 达到更多	积极	2023-01-17
				Placebo	簾窪餘鑰鬱鹽餘選鹹選(選獵窪膚壓顧構夢築蓋) = 淵網構膚築遞選鬱繭選廠艱願廠範餘憲構糧餘 (繭艱構網糧製製積獵艱 ) 达到更多