PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced positive topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) when co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), both AS01-adjuvanted vaccines (NCT05966090).1,2 The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress in Valencia, Spain (September 18-20th, 2024).2 SHINGRIX is approved for the prevention of shingles (herpes zoster) in adults aged 50 years and older.

费城--（商业新闻短讯）--葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，在50岁及以上的成年人中进行的第三阶段试验的阳性topline数据，评估了阿瑞克维（呼吸道合胞病毒疫苗，佐剂）与SHINGRIX（带状疱疹重组疫苗，佐剂）共同给药时的免疫原性，反应原性和安全性，这两种AS01佐剂疫苗（NCT05966090）。1,2这些数据作为最新摘要提交给了西班牙巴伦西亚欧洲老年医学会（EuGMS）大会（2024年9月18日至20日）。2 SHINGRIX被批准用于预防带状疱疹（2024年9月18日）带状疱疹）在50岁及以上的成年人中。

AREXVY is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV..

AREXVY被批准用于预防由呼吸道合胞病毒（RSV）引起的60岁及以上个体以及50至59岁由RSV引起的LRTD风险增加的个体的下呼吸道疾病（LRTD）。

The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits.2 Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles.2 In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.2 The duration of solicited adverse events was comparable across the two groups.2.

数据显示，与单独就诊时相比，共同接种疫苗时的免疫反应并不差[2]。共同接种也具有良好的耐受性，具有可接受的反应原性和安全性[2]。在两组中，最常报告的不良事件是注射部位疼痛，疲劳和肌痛[2]。两组不良事件的持续时间相当。

Len Friedland, MD, Vice President of Scientific Affairs and Public Health, GSK, said: “We are excited to share data on the co‑administration of our RSV and shingles vaccines. Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate.

葛兰素史克（GSK）科学事务和公共卫生副总裁伦弗里德兰（LenFriedland）医学博士表示：“我们很高兴分享我们的RSV和带状疱疹疫苗共同管理的数据。成人免疫提供了巨大的个人和社会效益，但成人的疫苗接种率往往不足。

With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles.”.

通过我们的共同管理研究，葛兰素史克正在利用其科学技术来帮助消除成人免疫的障碍，可能会减少前往医疗保健办公室和药店的次数，并最终有助于超越RSV和带状疱疹。”。

Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulators.

该试验的结果将提交同行评审的科学出版物，并将用于支持向美国食品和药物管理局（FDA），欧洲药品管理局（EMA）和其他监管机构提交的监管报告。

Both RSV and shingles pose significant health risks to older adults, and these risks only increase with age as the immune system declines. Immunocompromised individuals and those with certain underlying medical conditions—for example, asthma and COPD—may also be at increased risk for these diseases.3,4,5 RSV is a common, contagious respiratory virus that can lead to potentially serious respiratory illness.3 Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV and an estimated 14,000 of those cases result in death.6 Shingles is a painful, blistering rash that can last for weeks.

呼吸道合胞病毒和带状疱疹都对老年人构成严重的健康风险，随着免疫系统的下降，这些风险只会随着年龄的增长而增加。免疫功能低下的个体和患有某些潜在疾病的个体（例如哮喘和COPD）也可能患上这些疾病的风险增加[3,4,5]。RSV是一种常见的传染性呼吸道病毒，可导致潜在的严重呼吸道疾病[3]。每年，美国约有177000名65岁及以上的成年人因RSV住院，估计其中14000例导致死亡[6]。带状疱疹是一种疼痛的水疱性皮疹，可持续数周。

Because it is caused by the reactivation of the varicella zoster virus (VZV)—the same virus that causes chickenpox—99% of US adults have the virus that causes shingles inside their body, although not everyone will develop shingles.7 An estimated one million people develop shingles annually in the US.8.

因为它是由水痘带状疱疹病毒（VZV）的重新激活引起的，而水痘带状疱疹病毒（VZV）是引起水痘的同一种病毒。99%的美国成年人患有引起体内带状疱疹的病毒，尽管并非每个人都会患带状疱疹。7据估计，美国每年有100万人患带状疱疹。

About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

关于AREXVY（呼吸道合胞病毒疫苗，佐剂）

AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe, Japan and US.

AREXVY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。该疫苗已被批准用于预防欧洲、日本和美国等50个国家60岁及以上人群的RSV-LRTD。

It is also approved in several countries for use in adults aged 50–59 at increased risk for RSV-LRTD, including European Union/European Economic Area and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets..

一些国家（包括欧盟/欧洲经济区和美国）也批准将其用于RSV-LRTD风险增加的50-59岁成年人。多个国家的监管审查正在进行中。拟议的商品名仍需在其他市场获得监管部门的批准。。

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QS-21刺激素佐剂，该佐剂由Agenus Inc.的全资子公司Antigenics Inc.许可。

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

AREXVY是一种主动免疫疫苗，用于预防呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）：

Individuals 60 years of age and older;

60岁及以上的个人；

Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

。

Important Safety Information for AREXVY

AREXVY的重要安全信息

AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY.

对于任何对AREXVY的任何成分有严重过敏反应（例如过敏反应）史的人，AREXVY是禁忌的。

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY.

服用AREXVY后，必须立即进行适当的治疗，以控制潜在的过敏反应。

Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting.

晕厥（晕厥）可能与注射疫苗（包括阿瑞克维）有关。应制定程序以避免晕厥造成伤害。

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

免疫功能低下的人，包括那些接受免疫抑制治疗的人，可能对阿瑞克维的免疫反应减弱。

In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).

在60岁及以上的成年人中，最常见的不良反应（≥10%）是注射部位疼痛（60.9%），疲劳（33.6%），肌痛（28.9%），头痛（27.2%）和关节痛（18.1%）。

In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%).

在50至59岁的成年人中，最常见的不良反应（≥10%）是注射部位疼痛（75.8%），疲劳（39.8%），肌痛（35.6%），头痛（31.7%），关节痛（23.4%），红斑（13.2%）和肿胀（10.4%）。

There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age.

没有关于孕妇或母乳喂养者使用AREXVY的数据。AREXVY不被批准用于50岁以下的人群。

Vaccination with AREXVY may not result in protection of all vaccine recipients.

接种AREXVY疫苗可能不会保护所有疫苗接种者。

Please see full Prescribing Information for AREXVY.

请参阅AREXVY的完整处方信息。

About SHINGRIX (Recombinant Zoster Vaccine or RZV)

关于SHINGRIX（重组带状疱疹疫苗或RZV）

SHINGRIX is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 and over from shingles.9,10 RZV is not indicated to prevent primary varicella infection (chickenpox).

SHINGRIX是一种非活的重组亚单位疫苗，用于预防50岁及以上成年人的带状疱疹。它将抗原糖蛋白E与佐剂系统AS01B结合在一起，可能有助于克服免疫反应的自然年龄相关下降，这有助于保护50岁及以上的成年人免受带状疱疹的挑战[9,10]。RZV不适用于预防原发性水痘感染（水痘）。

In several countries, it is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label..

在一些国家，它也被批准用于18岁或以上带状疱疹风险增加的成年人。RZV的使用应符合官方建议和当地产品标签。。

About the NCT05966090 trial

关于NCT05966090试用版

The co-administration study is a phase 3, open-label, multi-country study to assess non-inferiority of immune responses in co-administration of GSK’s RSV and Recombinant Zoster Vaccine (RZV) compared to separate administration in adults aged 50 and over.2

共同给药研究是一项第三阶段，开放标签，多国研究，旨在评估与50岁及以上成年人单独给药相比，共同给药葛兰素史克RSV和重组带状疱疹疫苗（RZV）的免疫反应的非劣效性

530 participants were randomized 1:1 to receive either GSK’s Recombinant Zoster Virus vaccine first dose and GSK’s Respiratory Syncytial Virus, Adjuvanted at visit one (Co-ad), or GSK’s Recombinant Zoster Virus vaccine first dose alone at visit one (Control). The Control group received GSK’s RSV vaccine at day 31.1,2 RZV second dose was administered at day 61 for both groups.1,2 The primary endpoint was the non-inferiority of the humoral immune responses to GSK’s RSV vaccine and RZV when co-administered compared to when administered at separate visits.1,2 Key secondary endpoints included reactogenicity and safety following co-administration versus sequential administration of GSK’s RSV vaccine and RZV.1,2.

530名参与者以1:1的比例随机接受GSK重组带状疱疹病毒疫苗第一剂和GSK呼吸道合胞病毒，在第一次就诊时佐剂（Co ad），或在第一次就诊时单独接受GSK重组带状疱疹病毒疫苗第一剂（对照）。对照组在第31.1,2天接受GSK的RSV疫苗。两组在第61天给予RZV第二剂。1,2主要终点是共同给药时对GSK的RSV疫苗和RZV的体液免疫应答的非劣效性。1,2关键的次要终点包括共同给药与顺序给药GSK的RSV疫苗和RZV后的反应原性和安全性。

Anti-gE antibody concentrations and RSV-A and RSV-B neutralization titers increased from pre- to post-vaccination and met the non-inferiority criteria in the primary endpoint for the humoral immune responses to GSK’s RSV and shingles vaccines.2 In both groups, the duration of solicited adverse events was short and comparable, and the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.2 Unsolicited adverse events reporting rates were balanced between the co-administration and control groups.2.

抗gE抗体浓度和RSV-A和RSV-B中和滴度从接种前到接种后增加，并且在对GSK的RSV和带状疱疹疫苗的体液免疫应答的主要终点中符合非劣效性标准。在两组中，请求不良事件的持续时间短且可比，最常报告的不良事件是注射部位的疼痛，疲劳和肌痛。共同给药组和对照组之间的未经请求的不良事件报告率是平衡的。

About RSV in Adults

关于成年人的RSV

RSV is a common, contagious respiratory virus affecting the lungs and breathing passages.3 Adults can be at increased risk for RSV disease due to certain underlying medical conditions, immune compromised status, or advanced age.3 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.3.

RSV 是一种常见的传染性呼吸道病毒，会影响肺部和呼吸通道。3 由于某些潜在的疾病、免疫功能低下状态或高龄，成人患 RSV 疾病的风险可能会增加。3 RSV 会加剧病情，包括 COPD、哮喘和慢性心力衰竭，并可能导致严重的后果，例如肺炎、住院和死亡。

About Shingles

关于Shingles

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.11 By age 50, VZV is present in most adults12 and may reactivate with advancing age.13 As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.11 Shingles typically presents as a rash, with painful blisters across the chest, abdomen, or face.11 The pain is often described as aching, burning, stabbing or shock-like.14 Following the rash, a person may experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and occasionally persists for several years.14 PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.15.

带状疱疹是由水痘带状疱疹病毒（VZV）的再激活引起的，这种病毒与引起水痘的病毒相同.11到50岁时，大多数成年人中都存在VZV 12，并可能随着年龄的增长而重新激活.13随着年龄的增长，免疫系统对感染的反应减弱，增加了发生带状疱疹的风险.11带状疱疹通常表现为皮疹，胸部，腹部或面部有疼痛的水泡.11疼痛通常被描述为疼痛，灼烧，刺痛或休克样.14皮疹后，一个人可能会经历带状疱疹后神经痛（PHN），这是一种持续数周或更长时间的神经痛几个月，偶尔会持续数年.14 PHN是带状疱疹最常见的并发症，根据各种研究的结果，在所有带状疱疹病例中有5-30%发生。

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生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。