GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV.

葛兰素史克股份有限公司（LSE/NYSE:GSK）今天宣布了Arexvy（呼吸道合胞病毒疫苗，重组佐剂）在18-49岁成年人中的新初步数据，这些成年人由于某些潜在的医疗条件和免疫功能低下而患RSV-LRTD的风险增加。这些数据表明，该疫苗有可能帮助保护更广泛的成年人免受RSV潜在的严重后果的影响。

In the US alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million.1.

仅在美国，18-49岁的成年人中至少有一种危险因素可能使他们面临RSV疾病的风险，其人数可能超过2100万。

The vaccine is currently approved for use in adults aged 60 and above in over 50 countries, and in adults aged 50-59 at increased risk in a number of countries including the US and Europe*. There are currently no RSV vaccines recommended for adults younger than 60 years of age who are at increased risk for RSV disease, despite the burden of disease in this population..

该疫苗目前已被批准用于50多个国家60岁及以上的成年人，以及包括美国和欧洲在内的许多国家50-59岁风险增加的成年人*。尽管该人群有疾病负担，但目前尚无针对60岁以下RSV疾病风险增加的成年人推荐的RSV疫苗。。

Tony Wood, Chief Scientific Officer, GSK, said: “These promising data add to the evidence supporting GSK’s RSV vaccine and could help expand protection to more adults at risk from RSV disease. They also provide valuable insights into the potential impact of a second dose for certain populations. We’re committed to working with health authorities and regulators to help adults at increased risk of RSV disease benefit from vaccination.”.

葛兰素史克首席科学官托尼·伍德（TonyWood）说：“这些有希望的数据增加了支持葛兰素史克RSV疫苗的证据，有助于扩大对更多有RSV疾病风险的成年人的保护。它们还为第二剂对某些人群的潜在影响提供了宝贵的见解。我们致力于与卫生当局和监管机构合作，帮助RSV疾病风险增加的成年人从疫苗接种中受益。”。

In the phase IIIb trial (NCT063894872) a single dose of the vaccine elicited robust immune responses in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions (n=395). The immune response was non-inferior to that observed in adults aged 60 and above (n=417), meeting the trial’s co-primary endpoints..

在IIIb期试验（NCT063894872）中，由于某些潜在的医疗条件（n=395），单剂量的疫苗在18-49岁的成年人中引发了强烈的免疫反应，RSV-LRTD的风险增加。免疫反应不逊于60岁及以上的成年人（n=417），符合试验的共同主要终点。。

In the phase IIb trial (NCT059219033) a single dose of the vaccine showed a robust immune response in adults aged 18 and above who are immunocompromised due to kidney or lung transplant (n=131), with a second dose (n=130) eliciting responses similar to those of healthy adults aged 50 and older who received one dose (n=125).

在IIb期试验（NCT059219033）中，单剂疫苗在18岁及以上因肾或肺移植（n=131）而免疫功能低下的成年人中显示出强烈的免疫反应，第二剂（n=130）引发的反应类似于接受一剂（n=125）的50岁及以上健康成年人的反应。

These immune responses were consistent for RSV-A and RSV-B subtypes in all groups (those who received 1 or 2 doses). These data will be presented today at the meeting of the CDC’s Advisory Committee on Immunization Practices..

这些免疫反应对于所有组（接受1或2剂量的组）中的RSV-A和RSV-B亚型是一致的。这些数据将于今天在CDC免疫实践咨询委员会会议上公布。。

In both studies, the safety and reactogenicity data were consistent with results from the phase III programme that have supported the initial approval of the vaccine. The most common local adverse event was pain, and most common systematic adverse events were fatigue, myalgia, arthralgia and headache, most of which were transient and mild in intensity..

在这两项研究中，安全性和反应原性数据与支持疫苗初步批准的III期计划的结果一致。最常见的局部不良事件是疼痛，最常见的系统不良事件是疲劳，肌痛，关节痛和头痛，其中大多数是短暂的，强度较轻。。

RSV is a common, contagious virus that can cause severe respiratory illness and impacts an estimated 64 million people of all ages globally every year.4 Immunocompromised people and those with certain underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions,5,6 including having a higher risk of mortality.7.

RSV是一种常见的传染性病毒，可引起严重的呼吸系统疾病，每年影响全球约6400万人。免疫功能低下的人和患有某些潜在疾病的人，如慢性阻塞性肺病（COPD），哮喘，心力衰竭和糖尿病，与没有这些疾病的人相比，RSV感染导致严重后果的风险增加[5,6]，包括死亡风险更高[7]。

Final results from these trials will be presented at upcoming medical conferences and submitted for peer-reviewed publication. The final data will also be submitted to the US Food and Drug Administration (FDA) and other regulators to support potential label updates.

这些试验的最终结果将在即将举行的医学会议上提交，并提交同行评审出版物。最终数据也将提交给美国食品和药物管理局（FDA）和其他监管机构，以支持潜在的标签更新。

About the trial designs

关于试验设计

NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the GSK’s RSV vaccine in adults aged 18-49 at increased risk for RSV disease (n=395) compared to adults aged 60 and older (n=417). 1,457 participants were enrolled across 52 locations in 6 countries..

NCT06389487是一项IIIb期开放标签研究，旨在评估免疫反应的非劣效性，并评估18-49岁成年人与60岁及以上成年人相比，RSV疾病风险增加（n=395）的GSK RSV疫苗的安全性（n=417）。1457名参与者在6个国家的52个地点注册。。

The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titers expressed as mean geometric titer ratio (relative to older adults over adults at increased risk) and sero-response in RSV-A and RSV-B neutralising titers one month post vaccine administration. There were also safety and immunogenicity secondary endpoints.

该试验的共同主要终点是RSV-A和RSV-B中和滴度，表示为平均几何滴度比（相对于风险增加的成年人），以及疫苗给药后一个月RSV-A和RSV-B中和滴度的血清反应。还有安全性和免疫原性次要终点。

An additional cohort of 601 participants aged 18-49 were followed up for adverse events separate to safety follow up of the initial cohort. The study is ongoing to collect further safety and immunogenicity data up to 6 months post vaccination and is expected to finish in 2025..

另外对601名年龄在18-49岁的参与者进行了随访，以了解与初始队列安全性随访无关的不良事件。该研究正在进行中，以收集疫苗接种后6个月内的进一步安全性和免疫原性数据，预计将于2025年完成。。

NCT05921903 is a phase IIb, randomized, controlled, open-label, multi-country study to evaluate 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 1 versus 2 doses (1 dose, n=131, 2 doses, n=130) one month (30-42 days) 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 (n=125 non-immunocompromised adults aged 50 and above).

NCT05921903是一项IIb期，随机，对照，开放标签，多国研究，用于评估因肺和肾移植而免疫功能低下的成年人（≥18岁）中GSK RSV疫苗的免疫反应和安全性，比较第二次疫苗接种后一个月（30-42天）1剂与2剂（1剂，n=131,2剂，n=130）与接受单剂GSK RSV疫苗的50岁及以上非免疫功能低下成年人（n=125名50岁及以上非免疫功能低下成年人）的对照组相比。

386 participants were enrolled across 48 locations in 8 countries..

386名参与者在8个国家的48个地点注册。。

The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titers following a first and a second dose of GSK’s RSV vaccine expressed as mean geometric increase post dose 2 relative to post dose 1 at approximatively one month. There were also safety and immunogenicity secondary endpoints. The study is ongoing to collect further safety and immunogenicity data up to 12 months post last dose and is expected to finish in 2025..

该试验的共同主要终点是第一剂和第二剂GSK RSV疫苗后的RSV-A和RSV-B中和滴度，表示为剂量2后相对于剂量1后大约一个月的平均几何增加。还有安全性和免疫原性次要终点。该研究正在进行中，以收集最后一次给药后12个月内的进一步安全性和免疫原性数据，预计将于2025年完成。。

About GSK’s RSV vaccine

关于葛兰素史克的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 AS01E adjuvant.

呼吸道合胞病毒疫苗（佐剂）含有稳定在融合前构象（RSVPreF3）中的重组RSV糖蛋白F。该抗原与GSK专有的AS01E佐剂结合。

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.

这种疫苗的使用应符合官方建议。与任何疫苗一样，可能不会在所有接种者中引发保护性免疫反应。

The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in more than 50 countries, including Europe, Japan and US. In addition, it is approved in the US and EU/EEA countries for use in individuals aged 50-59 who are at increased risk due to certain underlying medical conditions.

该疫苗已在包括欧洲、日本和美国在内的50多个国家被批准用于预防60岁及以上人群的RSV-LRTD。此外，该疫苗已在美国和欧盟/欧洲经济区国家被批准用于50-59岁因某些潜在疾病而风险增加的人。

Regulatory reviews for this extended indication are also undergoing review in other countries – including Japan. The proposed trade name remains subject to regulatory approval in other markets..

包括日本在内的其他国家也正在对这种扩展适应症进行监管审查。。。

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

GSK专有的AS01佐剂系统包含从Agenus Inc的全资子公司Antigenics Inc.许可的STIMULON QS-21佐剂。STIMULON是Agenus的子公司SasioQX Inc.的商标。

About GSK

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.

葛兰素史克是一家全球性的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。更多信息请访问gsk.com。