Anti-RSV MAb-YTE、Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897 .gamma.1-chain), disulfide with monoclonal med18897 .kappa.-chain, dimer、Immunoglobulin g1-kappa, anti-(human respiratory syncytial virus fusion glycoprotein f0 (protein f))human monoclonal antibody.gamma.1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03

+ [13]

靶点

RSV F protein

作用方式

抑制剂

作用机制

呼吸道合胞病毒F蛋白抑制剂

治疗领域

感染呼吸系统疾病

在研适应症

呼吸道合胞体病毒感染呼吸道合胞病毒肺炎下呼吸道感染

非在研适应症-

原研机构

AstraZeneca AB

在研机构

Sanofi Pasteur SA

AstraZeneca PLC

Sanofi Winthrop Industrie SA

+ [5]

非在研机构

MedImmune LLC

最高研发阶段批准上市

首次获批日期

欧盟 (2022-10-31),

呼吸道合胞病毒肺炎

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先药物（PRIME） (欧盟)、优先审评 (中国)、加速审评 (欧盟)、潜力创新药 (英国)、突破性疗法 (中国)

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结构/序列

Sequence Code 64418264L

来源: *****

Sequence Code 315645337H

来源: *****

关联

项与尼塞韦单抗相关的临床试验

NCT06856967

/ RecruitingN/AIIT

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: a Case-Control Study

This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.

开始日期2024-12-04

申办/合作机构-

NCT06172660

/ RecruitingN/AIIT

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?

开始日期2024-10-01

申办/合作机构

Yale University

[+1]

NCT06551506

/ Recruiting临床4期IIT

A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.

开始日期2024-09-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与尼塞韦单抗相关的临床结果

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100 项与尼塞韦单抗相关的转化医学

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100 项与尼塞韦单抗相关的专利（医药）

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240

项与尼塞韦单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Respiratory syncytial virus immunization with nirsevimab: Acceptance and satisfaction assessment in infants and risk groups in the region of Murcia (Spain)

Article

作者: Sánchez Manresa, Susana ; del Pilar Ros Abellán, María ; Jesús Pérez Martín, Jaime ; de la Cruz Gómez Moreno, María ; Zornoza-Moreno, Matilde

Respiratory syncytial virus (RSV) is a leading cause of respiratory infections in infants under two years of age, often resulting in bronchiolitis and pneumonia, which contribute to high hospitalization rates. The recent approval of nirsevimab, a long-acting monoclonal antibody, has provided an immunization alternative for infants, addressing the substantial burden of RSV. This study aimed to evaluate acceptance and satisfaction among parents or legal guardians of infants who were candidates for immunization with nirsevimab in the Region of Murcia (Spain) during the 2023-2024 campaign. A cross-sectional survey, encompassing 1692 parents of immunized infants and 219 of non-immunized infants, revealed a high acceptance rate for nirsevimab, with 87% of parents indicating willingness to immunize a future child and 86.6% willing to recommend it. Concerns about safety and side effects were the primary reasons for hesitation among parents who did not immunize their infants. These findings underscore the importance of enhancing educational efforts in future campaigns to address safety concerns, thereby supporting broader RSV immunization coverage in the pediatric population.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of wastewater and environmental monitoring of respiratory syncytial virus to guide universal infant immunoprophylaxis in Canada

Article

作者: Paes, Bosco A. ; Rodgers-Gray, Barry S. ; Thampi, Nisha ; Delatolla, Robert ; Keary, Ian P. ; Mercier, Élisabeth ; Fullarton, John R.

AIMS:

To compare the cost-effectiveness of wastewater and environmental monitoring (WEM) versus clinical surveillance (CS)-guided respiratory syncytial virus (RSV) prophylaxis programs in Canada.

MATERIALS AND METHODS:

A cost-utility model was developed comprising two identical decision trees for RSV-WEM and RSV-CS. Within each tree, children could conservatively receive nirsevimab prophylaxis (71% coverage) or not at the start of the RSV season and subsequently experience an RSV-related hospitalization, medically-attended, non-hospitalized RSV-infection, or be uninfected/non-medically attended. All children could experience respiratory morbidity up to age 18 years, with higher rates following RSV-related hospitalization. All prophylaxis and RSV-related costs were identical for RSV-WEM and RSV-CS. No costs were assumed for RSV-CS; whereas a cost of CAD$12.31 per infant (infrastructure: CAD$4.07 plus sampling: CAD$8.24) was assumed if a new RSV-WEM system was initiated, with all infrastructure costs included in year 1. Predicated on data from the 2022-23 Ontario RSV season, RSV-WEM was assumed to provide a 15.1% benefit for earlier initiation of the prophylaxis program versus RSV-CS. Outcomes were modelled over an 18-year time horizon (1.5% discounting).

RESULTS:

RSV-WEM dominated (lower costs and higher utilities) RSV-CS and remained unaltered in all scenario analyses. Scenarios included: amortization of RSV-WEM infrastructure costs over 5 years; using existing WEM infrastructure for RSV detection; 25% reduction in extra cases identified by RSV-WEM; 50%-90% prophylaxis coverage based on real-world data; and 25% increase in the cost of RSV-WEM.

CONCLUSIONS:

The integration of RSV-WEM appears a highly cost-effective strategy (vs RSV-CS exclusively) to guide the earlier launch of RSV seasonal prophylaxis in Canada.

2025-12-31·Human Vaccines & Immunotherapeutics

Health economic evaluation of implementing a universal immunization program with nirsevimab compared to standard of care for the prevention of respiratory syncytial virus disease in Canadian infants

Article

作者: Wu, Jianhong ; Kieffer, Alexia ; Shin, Thomas ; Greenberg, Michael ; Lee, Jason Kh

Respiratory syncytial virus (RSV) is a highly contagious pathogen and a leading cause of severe lower respiratory tract illness (LRTI) in infants and young children, irrespective of risk factors. Nirsevimab, an extended half-life monoclonal antibody, was approved in Canada in 2023 as a passive immunizing agent for the prevention of RSV LRTI. This study evaluated the optimal price per dose (PPD) at commonly accepted willingness-to-pay (WTP) thresholds among Canadian infants compared to the current standard of care (i.e. palivizumab for preterm infants and those with specific medical conditions). A static decision tree model was developed to assess the impact of nirsevimab on RSV-related health and economic outcomes among Canadian infants - including outpatient physician and emergency department visits, inpatient hospitalizations including intensive care unit (ICU) admissions and mechanical ventilation, and the associated healthcare costs of these outcomes. The model utilized Canadian epidemiological and cost inputs where possible, adopting a societal perspective. Compared to the standard of care, nirsevimab was expected to prevent 47,609 RSV-related health events, including 2,296 hospitalizations and a reduction of approximately $45 million in direct healthcare costs. At a WTP threshold of $50,000 per quality-adjusted life-year (QALY), the estimated base case PPD was $536, based on average cost assumptions across several costing scenarios. These findings suggest that universal immunization with nirsevimab could significantly reduce the health and economic burden of RSV among Canadian Infants.

496

项与尼塞韦单抗相关的新闻（医药）

2025-04-08

·astrazeneca.com

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025

AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) in Vienna, Austria, from 11-15 April 2025. With 13 abstracts, including two oral presentations and two late-breaking poster presentations, the Company will highlight progress in advancing novel immunisations against bacterial and viral infectious diseases and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection. Benjamin Moutier, Senior Vice President, Vaccines & Immune Therapies, AstraZeneca said: “AstraZeneca is building an innovative portfolio of antibodies and vaccines to tackle two of the top global public health threats – serious bacterial infections and respiratory viral infections. At ESCMID, we’ll share data on three novel monoclonal antibodies targeting high-priority pathogens, highlighting our ambition to redefine care for serious bacterial infections. In addition, we will present 20 years of effectiveness data for Fluenz/FluMist, as well as real-world data highlighting the ongoing burden of RSV and hMPV, two leading causes of respiratory illnesses.” Advancing potential new options for serious bacterial infection prevention and treatment Serious bacterial infections pose significant and growing threats to global health, linked to an estimated 7.7 million deaths a year globally, leading to increasing morbidity and mortality for patients and a substantial burden on health systems.1 At ESCMID, the Company will share preclinical data on investigational monoclonal antibodies (mAbs) targeting three of the top five pathogens identified as urgent risks by the Centers for Disease Control and Prevention: Staphylococcus aureus (S. aureus): Oral presentation on in vivo expression of an mRNA-encoded multi-mechanistic mAb combination against S. aureus. There are millions of methicillin-resistant S. aureus (MRSA) infections annually worldwide, and MRSA is resistant to many types of antibiotics, making treatment highly complex. A pathogen-specific treatment strategy with mAbs targeting some S. aureus virulence factors represents an alternative to broad spectrum antibiotics.2 Pseudomonas aeruginosa (P. aeruginosa): Preclinical data showing that gremubamab, an anti-P. aeruginosa bispecific human mAb, may enhance neutrophil-mediated killing of P. aeruginosa in bronchiectasis patients. P. aeruginosa is a pathogen that colonizes one-third of patients with bronchiectasis, a chronic lung condition impacting about one million people globally and drives significant disease morbidity and mortality.3 Klebsiella pneumoniae (K. pneumoniae): Research on the development and characterisation of bispecific antibodies that protect against bacteraemia and pneumonia from the major serotypes of antibiotic-resistant K. pneumoniae in mouse models. Infections caused by K. pneumoniae are responsible for more than 700,000 yearly deaths worldwide.4 Real-world data examining the impact of respiratory infections AstraZeneca is presenting 20 years of real-world data on Fluenz/FluMist (live attenuated influenza vaccines, LAIV), recently approved in the U.S. as the only vaccine for self- or caregiver administration for the prevention of influenza, demonstrating long-term effectiveness comparable to that of inactivated (IIV) influenza vaccines in children.5 The Company will also present two late-breaking posters featuring real-world studies in patients with haematological malignancies who are highly susceptible to severe respiratory infections. The studies show that outcomes from human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) were similar to those from influenza and COVID-19, highlighting the need for development of novel options for preventing disease caused by hMPV and RSV.6,7 Retrospective analyses from Valencia, Spain, where there is systematic testing for multiple respiratory viruses, highlight the impact of RSV and influenza on severe disease and mortality in older adults throughout the COVID-19 pandemic, and suggest a potentially greater proportion of mechanical ventilation use and in-hospital death from RSV than influenza in adolescents and adults.8,9 Additional real-world data from France highlight the extensive healthcare resource utilisation due to hMPV and RSV and underline the need for routine testing for hMPV to accurately assess its true burden.10 Additionally, data being presented by our partner, Sanofi, confirm the significant public health impact and real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants.11 Furthering Research in COVID-19 Prevention Data on AZD6563, an investigational novel COVID-19 mRNA vaccine-like particle (VLP) vaccine, demonstrating that a low dose may elicit equivalent cell-mediated immunity to a licensed mRNA vaccine will also be shared.12 Additionally, data will be presented increasing confidence in a SARS-CoV-2 variant-agnostic threshold which could be used as a surrogate endpoint for benchmarking expected efficacy of novel mAbs for the prevention of COVID-19 against emerging variants.13 Key AstraZeneca presentations during ESCMID 2025 Abstract Title Presentation Details Abstract Title Early Science: Serious Bacterial Infections and Respiratory Viral Infections Abstract Title In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model Presentation Details Oral Presentation Session Title: Around the Lab in 80 Ways: A Journey Through Innovative Therapeutics Date: Saturday 12 April 2025 Time: 11 AM – 12 PM CEST Location: Hall 13 Abstract Title Low dose of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title A Bispecific Monoclonal Antibody Targeting Psl and PcrV Enhances Bronchiectasis Patient Neutrophil-Mediated Killing Of Pseudomonas aeruginosa Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-World Evidence: Respiratory Infections Abstract Title Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: A matched cohort analysis Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematological malignancies Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Similar proportions and temporal patterns of influenza, RSV, and hMPV among ESKD patients tested between 2020-2023 Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Characterization of hMPV and RSV cases in the French national hospital claims database during the 2022-2023 season Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Shifting viral landscapes: the impact of SARS-CoV-2 on hospitalization, ICU admission, and mortality in respiratory infections among older adults in Valencia, Spain Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Respiratory syncytial virus (RSV)-associated hospitalised influenza-like illness (ILI) and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015-2019/2020: the VALSARI study Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA) Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title COVID-19 mAbs Abstract Title Pharmacokinetics and immunogenicity of AZD7442 (Tixagevimab/Cilgavimab) in hospitalised COVID-19 patients: results from the DisCoVeRy trial Presentation Details Oral Presentation Session Title: New developments in prophylaxis and treatment of COVID-19 Date: Saturday 12 April 2025 Time: 11:00 Location: Hall 6 Abstract Title A threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Notes AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. GBD 2019 Antimicrobial Resistance Collaborators. Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2022 Dec 17;400(10369):2221-2248. 2. Tkaczyk C, Newton M et al. In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model. Oral Presentation. ESCMID Global 2025; Vienna, Austria. 2025. 3. Long MB, Gilmour A et al. A bispecific monoclonal antibody targeting Psl and PcrV enhances bronchiectasis patient neutrophil-mediated killing of Pseudomonas aeruginosa. Poster Presentation #P3642. ESCMID Global 2025; Vienna, Austria. 2025. 4. Doyle M, Smith A et al. Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen. Poster Presentation #P2377. ESCMID Global 2025; Vienna, Austria. 2025. 5. Stuurman AL, Enxing J et al. Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA). Poster Presentation #P0120. ESCMID Global 2025; Vienna, Austria. 2025. 6. Salmanton-Garcia J, Marchesi F et al. Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: a matched cohort analysis. Poster Presentation #P5067. ESCMID Global 2025; Vienna, Austria. 2025. 7. Marchesi F, Salmanton-Garcia J et al. Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematologic malignancies. Poster Presentation #P5066. ESCMID Global 2025; Vienna, Austria. 2025. 8. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0131. ESCMID Global 2025; Vienna, Austria. 2025. 9. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0132. ESCMID Global 2025; Vienna, Austria. 2025. 10. Binh Luong Nguyen L, et al. Characterisation of hMPV and RSV hospitalisations in the French national hospital claims database during the 2022-2023 season. Poster Presentation #P0183. ESCMID Global 2025; Vienna, Austria. 2025. 11. Mallah N, Pardo-Seco J, et al. Effectiveness of universal prophylaxis with nirsevimab for prevention of infant hospitalisations due to respiratory syncytial virus : full 2023-24 season analysis of the NIRSE-GAL study. Poster Presentation #P0124. ESCMID Global 2025; Vienna, Austria. 2025. 12. Swanson PA II, Padilla M et al. Low dosage of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine. Poster Presentation # P0482. ESCMID Global 2025; Vienna, Austria. 2025. 13. Edge R, Matthews S et al. A validated threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants. Poster Presentation #P0448. ESCMID Global 2025; Vienna, Austria. 2025. Corporate and financial

疫苗上市批准免疫疗法临床研究信使RNA

2025-02-20

·药时空

国内首部母婴RSV感染预防指南来了！重点包括……

*仅供医学专业人士阅读参考内附本指南的15条意见汇总呼吸道合胞病毒（RSV）是儿童群体中极为关键的病原体，其感染引发的组织病理学改变主要表现为急性细支气管炎、黏膜及黏膜下组织水肿。此外，上皮细胞的脱落、巨噬细胞的浸润以及纤维蛋白链与黏液性细胞碎片的混合物共同作用，会导致呼吸道管腔的阻塞[1]。在过去多数时期，关于RSV的指导方针和共识主要集中在儿童的预防措施和药物治疗上。当前，RSV在婴幼儿群体中的感染率呈现上升趋势，由此引发的并发症亦日益加剧[2]。基于此，我国出台了《母婴呼吸道合胞病毒感染预防指南（2025版）》[3]，旨在全面提升此类高风险群体的RSV感染防控水平。鉴于防范内容较多，笔者针对指南中提及的一些重要诊治内容，进行一文梳理。单克隆抗体在预防RSV中的运用推荐当前，我国市场仅批准了一种用于预防RSV感染的单克隆抗体药物，即尼塞韦单克隆抗体。在药理学机制上，尼塞韦单克隆抗体属于重组人源IgG1kappa型长效单克隆抗体，其作用机制在于能够与RSV融合蛋白（F蛋白）的F1和F2亚基特异性地高度结合，并将F蛋白稳定在前融合状态，从而有效阻断病毒对宿主细胞的侵入。 1、此类新生儿及婴儿推荐使用单克隆抗体（强推荐，GPS）： 1）即将出生或出生后即将进入RSV流行季节； 2）早产儿、低体重儿、未母乳喂养、有过敏史、母亲有吸烟史、6月龄以下等； 3）有唐氏综合征、合并支气管肺发育不良、血流动力学障碍先心病等。 2、针对0至1岁年龄段的新生儿及婴儿，单次应用RSV单克隆抗体注射可显著降低RSV感染风险（强推荐，中等质量证据）。 3、针对0至1岁年龄段的新生儿及婴儿，单次注射RSV单克隆抗体具有良好的安全性特征（强推荐，中等质量证据）。 4、RSV单克隆抗体的应用不会对其他疫苗接种产生干扰效应，因此新生儿及婴儿群体可按常规免疫计划进行其他疫苗的接种，无需进行接种计划的调整。目前关于RSV单克隆抗体与其他疫苗联合应用的经验有限，因此在临床实践中需要累积更多的监测数据以进行验证（强推荐，GPS）。 5、在我国，针对新生儿及婴儿群体采用单克隆抗体进行RSV感染预防的经济性尚未得到明确界定，因此无法提出相应的推荐性意见。亟待迅速开展针对该领域的药物经济学研究，并结合临床实践进行综合评价（弱推荐，GPS）。孕妇预防RSV，疫苗接种是重点在本次指南的更新内容中，亦涵盖了孕妇针对RSV的预防策略，其中疫苗接种是最为主要的预防手段。其次如果孕妇的分娩预期时间处于RSV流行季，建议孕妇在围产期采取积极措施预防RSV感染（弱推荐，GPS）。孕妇接种RSV疫苗或可作为一种被动免疫策略预防新生儿RSV感染。通过接种疫苗，孕妇体内抗体水平得以提升，这些抗体能够通过胎盘传递给胎儿，为新生儿在出生后的最初六个月提供必要的被动免疫保护。然而，截至目前，我国尚未有RSV疫苗获批上市，其在我国孕妇群体中的有效性与安全性仍需进一步的科学评估。目前孕妇接种疫苗预防RSV感染后，对胎儿的潜在影响主要包括两方面： 1、孕妇接种RSV疫苗可降低新生儿RSV感染的风险（弱推荐，高质量证据）。 2、孕妇接种RSV疫苗对胎儿宫内发育的潜在影响尚未明确，而其对早产风险的影响仍处于不确定状态（弱推荐，低质量证据）。居家和医疗机构均应注意防范RSV感染在家庭环境或医疗机构中，个体均面临RSV感染的风险。针对这两种不同场合，该指南提出了相应的预防策略。一居家：除疫苗接种外，亦应重视非药物预防策略。在RSV流行季节，建议家庭成员严格执行手部卫生和环境消毒程序、增强室内通风、限制不必要的外出活动、外出时正确佩戴口罩以及维持适当的社交距离，以降低母婴感染RSV的风险（强推荐，低质量证据）。具体包括：a.母乳喂养至少6个月；b.做好手卫生（乙醇类消毒剂、肥皂水）；c.养成良好的咳嗽卫生习惯；d.佩戴外科口罩；e.避免暴露于烟草和其他烟雾；f.参考《医疗机构消毒技术规范》[4]做好物体表面消毒；g.减少外出次数及保持社交距离等；h.加强健康教育、倡导合理膳食、适当锻炼与活动以及参与RSV防治宣教等措施。二医疗机构医疗机构不仅易成为交叉感染的媒介，且可能存在多重耐药菌株。因此对医疗机构的防护更为严格。具体包括： 1、儿科及妇产科医护人员需定期接受RSV感染防控的培训，内容涵盖母婴RSV感染的临床表征、预防策略以及治疗方案（强推荐，GPS）。 2、在RSV流行季节，医疗工作者应采取严格的防护措施，严格执行手部卫生规程。在进行可能产生气溶胶的高风险医疗操作时，应尽可能在隔离的独立空间内进行，并在操作完成后执行彻底的消毒程序（强推荐，GPS）。 3、针对新生儿或婴儿疑似或确诊感染RSV的情况，建议依据医疗资源的可用性实施隔离措施，以降低院内传播该病毒的风险（强推荐，GPS）。 4、在RSV流行季节，建议母婴在医院就诊过程中采取严格的防护措施，具体包括执行手部卫生规范和佩戴医用外科口罩等防护措施（强推荐，GPS）最后，笔者根据指南原文对本指南的15条意见进行汇总（表2）。在全球范围内，RSV对母婴健康构成了显著威胁，其防控工作遭遇了严峻挑战。随着疫苗研发、引进、评估及监测工作的不断推进，进一步探讨RSV感染预防措施对儿童远期并发症的潜在益处，积累我国人群的高质量研究数据和临床实践经验，持续提高我国母婴RSV感染的防控能力，显得尤为关键。表2 指南中的15条汇总意见及等级、质量等（源自指南） *GPS：良好实践声明参考文献： [1]Borchers, A. T., Chang, C., Gershwin, M. E., & Gershwin, L. J. (2013). Respiratory syncytial virus--a comprehensive review. Clinical reviews in allergy & immunology, 45(3), 331–379. [2]Griffiths, C., Drews, S. J., & Marchant, D. J. (2017). Respiratory Syncytial Virus: Infection, Detection, and New Options for Prevention and Treatment. Clinical microbiology reviews, 30(1), 277–319. [3]中华医学会围产医学分会.母婴呼吸道合胞病毒感染预防指南（2025年版）[J].中华围产医学杂志,2025,28(1):3-11. [4]中华人民共和国卫生部.WS/T367-2012医疗机构消毒技术规范[S].北京:中国标准出版社,2012. 识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗临床研究

2025-02-14

·同写意

赛诺菲挥别强生：50亿美元的黄粱一梦

本次直播免费参加，点击上方链接马上报名！坏结果似乎总是比预期来得更早。 2月13日，赛诺菲与强生宣布，将终止一项针对备受期待的实验性产品III期临床。而按照此前设想，该试验会在今年5月完成，有望诞生首款大肠杆菌疫苗ExPEC9V。结果，根据独立监测委员会的评审，ExPEC9V未能在预定的中期分析中显示出相较于安慰剂的显著益处。赛诺菲不无遗憾地在公告中表示，研究未发现安全性方面的担忧，但该疫苗在预防侵袭性大肠杆菌疾病方面“效果不足”。 ExPEC9V相关详细结果尚未对外发布，两家公司透露，后续会适时分享。 2021年，强生率先启动了这项研究，计划在全球数百个地点，对近20000名60岁及以上的成年人进行疫苗测试。ExPEC9V旨在对抗肠外致病性大肠杆菌（ExPEC），这是一种导致老年人败血症的主要病原，也可能引发脑膜炎和肺炎。 “ExPEC引起的菌血症和败血症是老年人十大死因之一，随着人口老龄化，病例数也在上升。”Jan Poolman分析说。他是强生旗下杨森细菌疫苗发现和早期开发负责人，20世纪70年代末进入疫苗开发领域。 Poolman认为，预防由细菌引起的严重疾病对于高危人群来说越来越紧迫，而大肠杆菌是罪魁祸首之一。在可见的将来，“老年人疫苗接种将像儿童免疫接种一样普及”，而强生将占有一席之地。不到四年，ExPEC9V被猝然抛弃，强生与赛诺菲的合作也画上句号。赛诺菲是在2023年10月“上车”的。根据最初的合作协议，赛诺菲向强生预付了1.75亿美元，并同意根据开发和商业化里程碑进行未来付款。2月13日的公告称，合作期间，赛诺菲向强生支付的款项总额为2.5亿美元。为此，这家疫苗巨头在第四季度计提2.5亿美元的税前减值费用，并将调整1月30日报告的收益。赛诺菲称，这项研究结果不会影响其2025年全年业绩预期。不过ExPEC9V要是成功获批，赛诺菲或许就另当别论了。它曾对该疫苗寄予厚望，一度告诉投资者，产品峰值销售额可达到20亿至50亿欧元——换言之，这是款最高一年创收52亿美元的重磅单品。 1月30日，赛诺菲发布2024年财报。在疫苗板块，赛诺菲的销售额约为90亿美元。与ExPEC9V相比起来，已经商业化的Beyfortus，或许才更有机会成为“全村希望”。Beyfortus目前RSV领域唯一一款婴幼儿用中和抗体，2022年在欧盟获得首批，2023年进入美国市场。在最新的财年里，Beyfortus销售额约18.29亿美元，同比增长214.4%。但需要看到，赛诺菲仍未走出核心产品，尤其是自身免疫疾病产品专利悬崖的危机。事实上，作为疫苗巨头，COVID-19期间，赛诺菲就错失了不少机会。转向流感mRNA疫苗后，开发进展也颇为不顺，最终叫停。赛诺菲选择合作的强生，虽然在COVID-19疫苗方面成功撞线，却不及辉瑞、Moderna等公司开发的第一梯队产品。 2023年3月，考虑到时间差和竞争压力，强生宣布退出RSV疫苗研发领域，关闭III期临床试验，哪怕其RSV疫苗在II期临床中显示出80%的预防效力。而这只是强生对传染病和疫苗部门进行大规模调整的一部分。公开信息显示，这次调整掀起全球大裁员，多款候选疫苗——HIV、COVID-19以及RSV——都被取消。 ExPEC9V的失败还有待具体数据分析，但赛诺菲与强生只维持短短一年多的联姻表明，钱并非新药开发的唯一决定因素。参考资料： Sanofi to take $250M charge on study failure for E. coli vaccine A vaccine for E. coli? Meet a researcher hot on the trail 同写意媒体矩阵，欢迎关注↓↓↓

疫苗财报临床3期引进/卖出

100 项与尼塞韦单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11380	-	-	DB16258

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	加拿大	AstraZeneca Canada, Inc.	2023-04-19
呼吸道合胞病毒肺炎	欧盟	Sanofi Winthrop Industrie SA	2022-10-31
呼吸道合胞病毒肺炎	冰岛	Sanofi Winthrop Industrie SA	2022-10-31
呼吸道合胞病毒肺炎	列支敦士登	Sanofi Winthrop Industrie SA	2022-10-31
呼吸道合胞病毒肺炎	挪威	Sanofi Winthrop Industrie SA	2022-10-31

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
下呼吸道感染	临床3期	美国	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	日本	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	阿根廷	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	澳大利亚	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	奥地利	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	比利时	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	保加利亚	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	加拿大	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	智利	AstraZeneca PLC	2019-07-23
下呼吸道感染	临床3期	哥伦比亚	AstraZeneca PLC	2019-07-23

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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


NCT06180993 (NIRSE-GAL, Pubmed) 人工标引	N/A	呼吸道合胞体病毒感染	10,259	nirsevimab	遞壓壓範繭衊齋築簾選(淵鹽鹹顧膚遞憲衊觸醖) = 糧選餘壓廠範觸襯鑰獵淵築齋網鑰網顧餘顧壓 (觸齋憲廠選膚簾鏇鬱鬱, 65.6 ~ 90.2) 更多	积极	2024-04-30
NCT03979313 (MELODY \| D5290C00004, CTgov)	临床3期	下呼吸道感染 \| 呼吸道合胞体病毒感染	3,012	Placebo (Placebo)	齋願淵範廠獵廠鏇積鏇: Relative Risk Reduction (RRR) = 74.53 (95% CI, 49.63 ~ 87.12), P-Value = <0.0001 更多	-	2024-02-28
				MEDI8897 (Medi8897)
NCT04484935 (MUSIC, CTgov)	临床2期	呼吸道合胞体病毒感染	100	Nirsevimab (Nirsevimab 50 mg/100 mg)	鹽糧遞淵顧廠願齋窪夢 = 鹹窪醖窪觸簾淵夢淵廠膚艱壓衊齋築網襯醖憲 (願製遞夢鹹憲繭艱鑰選, 醖鑰壓製蓋範網齋觸衊 ~ 遞遞鬱鏇窪醖憲獵獵獵) 更多	-	2023-11-15
				Nirsevimab (Nirsevimab 200 mg)	鹽糧遞淵顧廠願齋窪夢 = 艱壓築製壓製衊構積醖膚艱壓衊齋築網襯醖憲 (願製遞夢鹹憲繭艱鑰選, 膚鹹構糧構蓋獵膚範艱 ~ 淵淵築鏇遞範餘選憲遞) 更多
NCT04840849 (PK/ADA, CTgov)	临床1期	-	24	nirsevimab (Nirsevimab)	膚蓋襯範糧壓夢網廠積(廠鑰觸膚餘簾構齋簾鏇) = 壓窪鬱襯鏇顧窪遞築繭衊糧膚艱淵壓選積衊餘 (糧鹽壓鹽餘淵繭壓艱壓, NA) 更多	-	2023-11-02
				Placebo (Placebo)	襯鹽蓋製艱餘鏇築廠醖(蓋製鏇簾醖憲夢選餘獵) = 齋製網窪窪獵壓餘鏇糧膚鏇醖憲鑰願遞膚鹽壓 (遞繭醖範構餘壓鑰廠鬱, 簾淵蓋窪築願積窪襯衊 ~ 選夢壓窪鹽鹽鏇簾選簾) 更多
NCT03959488 (CTgov)	临床2/3期	呼吸道合胞体病毒感染	925	MEDI8897 (MEDI8897)	範範鑰構網選淵鹹鏇餘 = 鏇淵鑰餘齋憲製壓觸範餘範鬱糧選鏇願願願範 (顧簾獵憲網襯醖窪壓顧, 顧製獵顧齋構衊夢鹹艱 ~ 簾獵窪鹹鏇鹹觸範顧築) 更多	-	2023-09-21
				Palivizumab (Palivizumab)	範範鑰構網選淵鹹鏇餘 = 選餘獵夢憲簾衊蓋廠範餘範鬱糧選鏇願願願範 (顧簾獵憲網襯醖窪壓顧, 夢網遞築鏇簾築壓廠齋 ~ 襯鹹膚廠鏇範範網衊積) 更多
NCT02878330 (D5290C00003, FDA) 人工标引	临床2期	呼吸道合胞体病毒感染	1,453	BEYFORTUS	憲糧窪選構鏇範繭觸糧(襯願餘獵遞遞窪鬱築鹽) = 構夢製醖淵衊窪憲艱鹹築構鏇簾夢鏇構鹹壓襯 (獵願鹹糧範窪繭繭憲繭 )	积极	2023-07-17
				Placebo	憲糧窪選構鏇範繭觸糧(襯願餘獵遞遞窪鬱築鹽) = 鹽構選顧廠糧積廠積衊築構鏇簾夢鏇構鹹壓襯 (獵願鹹糧範窪繭繭憲繭 )
NCT03979313 (D5290C00004, FDA) 人工标引	临床3期	呼吸道合胞体病毒感染	1,490	BEYFORTUS	壓遞夢構鏇夢夢夢鏇齋(壓網遞衊鬱衊膚鬱蓋夢) = 顧鏇壓鏇獵顧繭窪醖願齋廠廠築艱膚醖積夢選 (淵鹽醖簾窪艱憲選鏇繭 )	积极	2023-07-17
				Placebo	壓遞夢構鏇夢夢夢鏇齋(壓網遞衊鬱衊膚鬱蓋夢) = 製糧鏇獵廠顧積願繭膚齋廠廠築艱膚醖積夢選 (淵鹽醖簾窪艱憲選鏇繭 )
NCT03979313 (Pubmed \| N Engl J Med) 人工标引	临床3期	呼吸道合胞体病毒感染	1,490	nirsevimab	構餘鏇衊鹹窪鑰廠顧醖(醖繭醖鹽顧網範鏇顧繭) = 壓範艱壓構製範糧廠蓋網壓繭蓋憲鏇糧獵網夢 (淵壓獵壓窪憲夢網淵淵 ) 更多	积极	2022-03-03
				Placebo	構餘鏇衊鹹窪鑰廠顧醖(醖繭醖鹽顧網範鏇顧繭) = 窪淵壓壓醖鹹憲憲窪網網壓繭蓋憲鏇糧獵網夢 (淵壓獵壓窪憲夢網淵淵 ) 更多
NCT02878330 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2期	呼吸道合胞体病毒感染	1,453	Nirsevimab	鹽遞憲衊網獵醖鑰鹽糧(築鏇蓋膚鏇顧膚廠網醖) = 遞選網憲衊衊簾醖糧構窪醖膚獵選餘築鬱鏇壓 (衊醖膚淵膚襯鏇鑰淵製 ) 更多	积极	2020-07-30
				Placebo	鹽遞憲衊網獵醖鑰鹽糧(築鏇蓋膚鏇顧膚廠網醖) = 壓顧糧窪夢壓製鏇鏇齋窪醖膚獵選餘築鬱鏇壓 (衊醖膚淵膚襯鏇鑰淵製 ) 更多
NCT02878330 (MEDI8897 Ph2b \| D5290C00003, CTgov)	临床2期	下呼吸道感染 \| 呼吸道合胞体病毒感染	1,453	Placebo (Placebo)	鏇淵選鹹膚鬱願獵範觸 = 積艱蓋壓窪範鏇壓鹽遞衊膚鏇觸膚繭鹽醖範鑰 (觸鏇願顧憲築襯鹽構膚, 積鏇積壓網鏇願艱鏇鏇 ~ 簾淵淵繭鑰繭衊顧淵壓) 更多	-	2019-10-14
				MEDI8897 (MEDI8897 50 mg)	鏇淵選鹹膚鬱願獵範觸 = 願構觸壓齋築艱壓夢鏇衊膚鏇觸膚繭鹽醖範鑰 (觸鏇願顧憲築襯鹽構膚, 製獵鹽範遞積壓淵蓋網 ~ 繭繭齋艱鑰築獵遞餘蓋) 更多