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GSK将在国际RSV研讨会上展示最新研究成果,以推进成人RSV预防工作

GSK to showcase latest research at the International RSV Symposium to advance RSV prevention in adults

葛兰素史克 等信源发布 2025-03-06 20:09

可切换为仅中文


World-leading experts to focus on RSV, a significant public health challenge with an estimated 64 million people of all ages impacted every year

世界领先的专家将聚焦于RSV,这是一个重大的公共卫生挑战,据估计每年有6400万各年龄段的人受到影响。

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17 abstracts to evaluate unmet medical need and approaches to RSV prevention in adults

评估成人未满足的医疗需求和RSV预防方法的17篇摘要

Results include immunogenicity and safety data for GSK’s RSV vaccine

结果包括GSK的RSV疫苗的免疫原性和安全性数据

GSK plc (LSE/NYSE: GSK) will share its latest research findings on the respiratory syncytial virus (RSV) at the 13

葛兰素史克(GSK plc,伦敦证交所/纽约证交所代码:GSK)将在第13届会议上分享其关于呼吸道合胞病毒(RSV)的最新研究发现。

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International RSV Symposium in Iguazu, Brazil (12-15 March).

国际RSV研讨会在巴西伊瓜苏举行(3月12日至15日)。

This symposium brings together the world's leading experts in the field to discuss the latest advancements in RSV research, prevention, and treatment.

本次研讨会汇集了该领域世界领先的专家,讨论RSV研究、预防和治疗的最新进展。

During the conference, GSK and collaborating experts will present a total of 17 abstracts covering a range of topics, including the epidemiology and burden of RSV, several late-stage clinical read outs on

在会议期间,GSK及合作专家将展示共计17篇摘要,涵盖多个主题,包括呼吸道合胞病毒(RSV)的流行病学与疾病负担,以及若干后期临床研究结果。

Arexvy

阿雷克斯维

(respiratory syncytial virus vaccine, recombinant adjuvanted), GSK’s RSV vaccine, cost-effectiveness modelling, and analysis of the potential impact of different circulating RSV strains on the efficacy of GSK’s RSV vaccine.

(呼吸道合胞病毒疫苗,重组佐剂),GSK的RSV疫苗,成本效益模型,以及不同流行RSV毒株对GSK的RSV疫苗效力潜在影响的分析。

Susie Barnes, SVP, Head of Global Medical Affairs, Vaccines said

苏西·巴恩斯,高级副总裁,全球医疗事务主管,疫苗部门表示

: “As a leader in innovation and prevention, we are committed to collaborating with the global scientific community to better understand the challenge of RSV in adults. To date, more than 11 million adults globally have received our RSV vaccine, generating robust data on the impact of immunisation to help improve public health and protect those at risk.”.

“作为创新和预防领域的领导者,我们致力于与全球科学界合作,以更好地了解成人RSV的挑战。迄今为止,全球已有超过1100万成年人接种了我们的RSV疫苗,产生了关于免疫影响的有力数据,有助于改善公共健康并保护高风险人群。”

An estimated 64 million people globally of all ages are impacted by RSV every year, including older adults and those with certain underlying medical conditions.

据估计,全球每年有6400万人受到RSV的影响,包括老年人和某些基础疾病患者。

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Despite RSV vaccines, including GSK’s vaccine, being available in over 60 markets, only a minority of eligible adults have been immunised so far. In the US, about 24% of eligible adults had received a RSV vaccine by the end of the 2023–24 season.

尽管包括葛兰素史克疫苗在内的呼吸道合胞病毒疫苗已经在超过60个市场上市,但迄今为止,只有少数符合条件的成年人接种了疫苗。在美国,截至2023-24季节末,约有24%的符合条件的成年人接种了呼吸道合胞病毒疫苗。

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The International RSV Symposium is an opportunity to present data to strengthen understanding of the risks of RSV in adults and the potential benefits of RSV vaccination amongst healthcare professionals and the scientific community.

国际RSV研讨会是一个展示数据的机会,以加强对成年人RSV风险的认识,并让医疗专业人员和科学界了解RSV疫苗接种的潜在益处。

Key abstracts to be presented at International RSV Symposium

将在国际RSV研讨会上展示的关键摘要

New data to advance understanding of and improve RSV prevention in adults:

用于增进对成人RSV预防的理解和改进的新数据:

AReSVi 004 – 36-month immunogenicity:

AReSVi 004 – 36个月免疫原性:

data from a phase 3 study evaluating immunogenicity and safety following administration of a second dose of GSK’s RSV vaccine 36 months after initial vaccination in adults aged 60 years and older.

一项三期研究的数据,评估了在60岁及以上成人中,初次接种GSK的RSV疫苗36个月后,接种第二剂疫苗后的免疫原性和安全性。

AReSVi 006 – strains sequencing:

AReSVi 006 – 菌株测序:

using GSK’s AReSVi-006 phase 3 efficacy study, this analysis focuses on the genetic variations of the virus over three RSV seasons and the potential breadth of efficacy of GSK’s RSV vaccine against these variations.

利用GSK的AReSVi-006第三阶段有效性研究,本分析重点关注病毒在三个RSV季节中的基因变异以及GSK的RSV疫苗对这些变异的潜在广泛有效性。

AReSVi 006 – patient reported outcomes:

AReSVi 006 – 患者报告的结果:

results from the analysis of patient-reported data evaluating the impact of RSV infection in vaccinated and non-vaccinated people enrolled over three RSV seasons in the phase 3 efficacy study.

来自对患者报告数据的分析结果,评估了在三期效力研究中,三个RSV季节期间注册的接种疫苗和未接种疫苗人群中RSV感染的影响。

NCT05921903 – vaccine dosing in immunocompromised patients

NCT05921903 - 免疫功能低下患者的疫苗剂量

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data from a phase 2b study evaluating the immune response and safety of GSK’s RSV vaccine in adults (≥18 years of age) who are immunocompromised due to lung and renal transplant, comparing one versus two doses one month after the second vaccine administration compared to a control group of non-immunocompromised adults aged 50 and above receiving a single dose of GSK’s RSV vaccine..

来自一项2b期研究的数据,评估了GSK的RSV疫苗在因肺和肾移植而免疫功能低下的成人(≥18岁)中的免疫反应和安全性,比较了在第二剂疫苗接种一个月后一剂与两剂的效果,并与接受单剂GSK RSV疫苗的50岁及以上非免疫功能低下成人对照组进行了对比。

NCT06389487 – vaccine response in immunocompromised patients:

NCT06389487 - 免疫功能低下患者的疫苗反应:

data from a phase 2b study evaluating the non-inferiority of the immune response and safety of GSK’s RSV vaccine in adults aged 18-49 at increased risk for RSV disease compared to adults aged 60 and older.

评估GSK的RSV疫苗在18-49岁高风险RSV疾病成人中的免疫反应和安全性是否不劣于60岁及以上成人的2b期研究数据。

Full list of GSK presentations at RSV Symposium

GSK在RSV研讨会上的完整演讲列表

Abstract name

抽象名称

Presenter

主持人

Presentation details

演示详情

The AS01

AS01

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-adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) attenuates the severity of RSV-associated disease in breakthrough infections in adults aged 60 years and above: analysis at the end of 3 RSV seasons

-佐剂RSV预融合F蛋白疫苗(佐剂RSVPreF3)在60岁及以上成人中减轻了突破性感染相关的RSV疾病严重程度:在3个RSV季节末的分析

Eliazar Sabater Cabrera (GSK)

埃利亚扎尔·萨巴特·卡布雷拉(GSK)

Oral presentation

口头报告

Immunogenicity and safety of the AS01

AS01的免疫原性和安全性

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-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) after different revaccination schedules up to 3 years post-first dose in adults aged 60 years and above

-在60岁及以上的成年人中,首次接种后长达3年内的不同再接种计划后的辅助型呼吸道合胞病毒预融合F蛋白疫苗(辅助型RSVPreF3)

Tino Schwartz

蒂诺·施瓦茨

Poster session

海报会议

Characterization of the antigenic specificity of the humoral response following primary versus repeated vaccination(s) with AS01E-adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3)

初次与重复接种AS01E佐剂RSV前融合F蛋白疫苗(佐剂RSVPreF3)后体液反应的抗原特异性特征对比

Lucile Warter (GSK)

吕西尔·瓦尔特(GSK)

Poster session

海报展示环节

Immune response and safety of the AS01

AS01的免疫反应和安全性

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-adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) in immunocompromised adults: Evaluating one vs two doses in lung and kidney transplant recipients, and compared to non-immunocompromised adults

免疫功能受损成人中的佐剂RSV预融合F蛋白疫苗(佐剂RSVPreF3):评估肺和肾移植受者中一剂与两剂的差异,并与非免疫功能受损成人进行比较

Veronica Hulstrom (GSK)

维罗尼卡·霍尔斯特罗姆(GSK)

Poster session

海报展示环节

The AS01

AS01

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-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) has a non-inferior immunogenicity profile in adults 18–49 years of age (YOA) at increased risk of RSV disease compared to adults 60 YOA and above, and a clinically acceptable safety profile

-adjuvanted呼吸道合胞病毒预融合F蛋白疫苗(adjuvanted RSVPreF3)在18-49岁(YOA)有较高RSV疾病风险的成年人中,与60岁及以上成年人相比,具有非劣效的免疫原性特征,并且安全性在临床上可接受。

Essack Mitha

埃萨克·米萨

Poster session

海报展示环节

The AS01

AS01

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E

-adjuvanted RSVPreF3 vaccine exhibits broad efficacy against diverse RSV strains

-adjuvanted RSVPreF3疫苗对多种RSV毒株表现出广泛的有效性

Lucile Warter (GSK)

吕西尔·瓦尔特(GSK)

Poster session

海报展示环节

Epidemiology of respiratory syncytial virus in adults in low, lower-middle, and upper-middle income countries: An artificial intelligence-enabled systematic literature review

成人呼吸道合胞病毒在低收入、中低收入和中高收入国家的流行病学:一项人工智能辅助的系统文献综述

Otavio Cintra (GSK)

奥塔维奥·辛特拉(GSK)

Poster session

海报展示环节

Modelled Public Health Impact of Adjuvanted RSVPreF3 Vaccination in Adults Aged 60 Years and Older in the United States over 5 Years

美国60岁及以上成人接种佐剂RSVPreF3疫苗的5年公共卫生影响模型

David Singer (GSK)

大卫·辛格(GSK)

Poster session

海报展示环节

Modelled public health impact of respiratory syncytial virus (RSV) vaccination among United States (US) adults aged 60 years and older during the first season of vaccine availability

在美国(US)60岁及以上成年人中,呼吸道合胞病毒(RSV)疫苗在首个接种季节的公共卫生影响模型

Eliana Biundo (GSK)

艾莉安娜·比翁多(GSK)

Poster session

海报展示环节

An overview of evolving recommendations for RSV active immunization in adults and their supporting clinical data

成人RSV主动免疫接种的不断发展的建议及其支持的临床数据概述

Nicolas Lecrenier (GSK)

尼古拉斯·勒克勒尼尔(GSK)

Poster session

海报展示环节

Modeled Public Health Impact of Adjuvanted RSVPreF3 Vaccination in Adults Aged 50-59 years at Increased Risk for Severe RSV Disease in the United States over 5 Years

在美国,50-59岁有严重RSV疾病风险的成人中,使用佐剂RSVPreF3疫苗接种的公共卫生影响模型预测:5年研究

David Singer (GSK)

大卫·辛格(GSK)

Poster session

海报展示环节

Characteristics Associated with Likelihood of RSV Testing in Adults Aged ≥50 Years in the United States

与美国50岁及以上成人RSV检测可能性相关的特征

David Singer (GSK)

大卫·辛格(GSK)

Poster session

海报展示环节

Clinical and economic burden of respiratory syncytial virus among adults hospitalized with acute respiratory infections in Portugal

葡萄牙成人急性呼吸道感染住院患者中呼吸道合胞病毒的临床与经济负担

Maria João Fonseca (GSK)

玛丽亚·若昂·丰塞卡(GSK)

Poster session

海报展示环节

Respiratory syncytial virus (RSV) vaccine recommendations for adults: a review of available global, regional, and country level recommendations.

成人呼吸道合胞病毒(RSV)疫苗建议:对全球、区域和国家层面可用建议的综述。

Otavio Cintra (GSK)

奥塔维奥·辛特拉(GSK)

Poster session

海报展示环节

Respiratory syncytial virus Disease Burden in Older Adults with and without comorbidities: a decade of hospitalization data in Brazil (2013-2023)

具有和不具有合并症的老年人呼吸道合胞病毒疾病负担:巴西十年住院数据(2013-2023)

Lessandra Michelin (GSK)

莱桑德拉·米其林(GSK)

Poster session

海报展示环节

Combining European Efforts: A Methodological Framework to Assess RSV Hospitalization Burden pre- and post-COVID-19 in Children through RESCEU and PROMISE Collaboration

结合欧洲的努力:通过RESCEU和PROMISE合作评估儿童在COVID-19前后RSV住院负担的方法学框架

Kocfa Chung-Delgado

高斯法·钟-德尔加多

Poster session

海报展示环节

RSV incidence estimates in primary care among adults aged 50 years and older in the Netherlands; 2011-2019

荷兰2011年至2019年间50岁及以上成人基层医疗中的RSV发病率估计

Claudia Laarman

克劳迪娅·拉尔曼

Poster session

海报展示环节

About RSV in adults

关于成人中的RSV

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death..

RSV是一种常见的传染性病毒,影响肺部和呼吸道。由于某些共病、免疫功能受损或高龄,成年人患RSV疾病的风险可能增加。RSV可能加重慢性阻塞性肺病(COPD)、哮喘和慢性心力衰竭等病情,并可能导致严重后果,如肺炎、住院甚至死亡。

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Each year RSV causes over 465,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.

每年,在高收入国家,RSV 导致 60 岁及以上成年人超过 465,000 例住院和 33,000 例死亡。

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About GSK’s RSV vaccine

关于GSK的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01

呼吸道合胞病毒疫苗(含佐剂)包含稳定在融合前构象的重组RSV糖蛋白F(RSVPreF3)。该抗原与GSK专有的AS01佐剂结合。

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adjuvant.

辅助剂。

The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

该疫苗的使用应遵循官方建议。与任何疫苗一样,并非所有接种者都会产生保护性免疫反应。

The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

GSK专有的AS01佐剂系统包含从Antigenics Inc(Agenus Inc的全资子公司)授权的QS-21 STIMULON佐剂。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司,致力于联合科学、技术和人才,共同战胜疾病。欲了解更多信息,请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性陈述的谨慎声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2024..

GSK提醒投资者,GSK所做的任何前瞻性声明或预测,包括本公告中所做的声明或预测,均受可能导致实际结果与预测结果存在重大差异的风险和不确定性的影响。这些因素包括但不限于GSK 2024年Form 20-F年度报告中第3.D项“风险因素”下所述的内容。

References

参考文献

National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at:

国立过敏与传染病研究所,呼吸道合胞病毒 (RSV)。可用资源:

https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

– last accessed: February 2025

– 最后访问时间:2025年2月

National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at:

国立过敏与传染病研究所,呼吸道合胞病毒 (RSV)。可用资源:

https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

– last accessed: February 2025

– 最后访问时间:2025年2月

K. Bajema et al., “Respiratory syncytial virus vaccine effectiveness among US veterans, September 2023 to March, 2024: a target trial emulation study” in

K. Bajema 等人,《2023年9月至2024年3月美国退伍军人中呼吸道合胞病毒疫苗有效性:一项目标试验模拟研究》

The Lancet Infectious Disease

柳叶刀传染病

, Published Online January 20, 2025

,发布于2025年1月20日在线

https://doi.org/10.1016/S1473-3099(24)00796-5

https://doi.org/10.1016/S1473-3099(24)00796-5

Centers for Disease Control and Prevention (CDC), RSV in Older Adults, 2024. Available at:

疾病控制与预防中心 (CDC),老年人中的RSV,2024。引用日期:

https://www.cdc.gov/rsv/older-adults/index.html

https://www.cdc.gov/rsv/older-adults/index.html

- Last accessed: September 2024

- 最后访问时间:2024年9月

Savic M, et al., “Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis”, in Influenza Other Respir Viruses, 2023, 17(1):e13031,

Savic M等人,“高收入国家60岁及以上成人呼吸道合胞病毒疾病负担:系统文献综述与荟萃分析”,《流感与其他呼吸道病毒》,2023年,17(1):e13031。

DOI: 10.1111/irv.13031

数字对象标识符:10.1111/irv.13031