share_log

New Data for Arexvy, GSK's Respiratory Syncytial Virus Vaccine, Show Potential to Help Protect a Broader Group of Adults at Increased Risk for RSV Disease

New Data for Arexvy, GSK's Respiratory Syncytial Virus Vaccine, Show Potential to Help Protect a Broader Group of Adults at Increased Risk for RSV Disease

關於GSK呼吸道合胞病毒疫苗Arexvy的新數據顯示,有潛力幫助保護更廣泛的成年人群,減少罹患RSV疾病風險。
葛蘭素史克 ·  10/24 12:00
  • Single dose of vaccine elicited robust immune response with acceptable safety profile in adults aged 18-49 at increased risk for RSV-LRTD
  • Two doses of vaccine in immunocompromised adults aged 18 and above elicited immune responses similar to one dose in healthy adults aged 50+ and with an acceptable safety profile
  • In the US alone, adults aged 18-49 with at least one risk factor for RSV disease could exceed 21 million1
  • 接種單劑疫苗可在年齡在18-49歲的患有RSV-LRTD增加風險的成年人中引發強大的免疫反應,並具有可接受的安全性。
  • 免疫功能受損的18歲及以上成年人接種兩劑疫苗引起的免疫反應類似於健康50歲以上成年人接種一劑疫苗,並具有可接受的安全性。
  • 僅在美國,年齡在18-49歲且至少有一種RSV疾病風險因素的成年人可能超過2100萬1。

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. 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

GSk plc (LSE/紐交所: GSK)今日宣佈了Arexvy(經重組佐劑化的呼吸道合胞病毒-疫苗)針對年齡在18-49歲的因特定基礎疾病增加RSV-LRTD風險的成年人和免疫受損成年人的新初步數據。這些數據顯示該疫苗有潛力幫助保護更廣泛的有RSV潛在嚴重後果風險的成年人。僅在美國,年齡在18-49歲且至少有一種風險因素可能使他們面臨RSV疾病風險的成年人可能超過2100萬1。

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.

該疫苗目前已獲批用於50多個國家的60歲及以上成年人,並已獲批用於一些國家,包括美國和歐洲的有風險的50-59歲成年人。目前沒有推薦給年齡小於60歲且有RSV疾病風險增高的成年人接種RSV疫苗,儘管這一人群中的疾病負擔很重。

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."

GSK首席科學官託尼·伍德表示:「這些有希望的數據進一步證實GSK的RSV疫苗,並可能幫助更多有RSV疾病風險的成年人獲得保護。它們也爲某些人群接種第二劑疫苗的潛在影響提供了寶貴的見解。我們致力於與衛生當局和監管機構合作,幫助有RSV疾病風險增加的成年人從接種中受益。」

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.

在第三期b試驗(NCT063894872)中,由於特定的基礎醫療狀況(n=395),單劑疫苗在年齡在18-49歲且有RSV-LRTD風險增加的成年人中引發了強大的免疫反應。免疫反應不亞於60歲及以上成年人(n=417),達到了試驗的共同主要終點。

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). 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.

在IIb期試驗(NCT059219033)中,該疫苗的單劑在18歲及以上因腎移植或肺移植而免疫受損的成年人(n=131)中展現出強有力的免疫反應,第二劑疫苗(n=130)引發的反應與接種一劑疫苗的50歲及以上健康成年人(n=125)類似。這些免疫反應對所有群體(接種1劑或2劑的人)的RSV-A和RSV-b亞型保持一致。這些數據將於今日在美國疾病控制與預防中心諮詢委員會的會議上發佈。

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.

在兩項研究中,安全性和反應原性數據與支持該疫苗獲得初步批准的III期項目結果一致。最常見的局部不良事件是疼痛,最常見的系統性不良事件是疲勞、肌肉疼痛、關節疼痛和頭痛,其中大多數是暫時且輕微的。

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是一種常見的傳染性病毒,可引起嚴重的呼吸道疾病,每年全球各年齡段約有6400萬人受影響。免疫受損的人群和某些患有慢性阻塞性肺病(COPD)、哮喘、心力衰竭和糖尿病等特定基礎疾病的人,比起沒有這些疾病的人,感染RSV後有更嚴重的後果,包括更高的死亡風險。

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.

這些試驗的最終結果將在即將舉行的醫學會議上發佈,並提交給同行評審出版。最終數據還將提交給美國食品藥品監督管理局(FDA)和其他監管機構,以支持潛在的標籤更新。

About the trial designs

關於試驗設計

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是一項IIIb期開放標籤研究,評估GSK的RSV疫苗在18-49歲處於RSV疾病高風險群體(n=395)中的免疫反應的非劣效性,並與60歲及以上的成年人(n=417)進行比較的安全性。在6個國家的52個地點招募了1,457名參與者。

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. 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.

該試驗的共同主要終點是RSV-A和RSV-b的中和抗體滴定比例(相對於年長者相對於處於高風險群體成年人),以及疫苗接種後一個月內RSV-A和RSV-b中和抗體的血清應答。還有安全性和免疫原性的次要終點。另外跟蹤了601名年齡爲18-49歲的參與者,進行了額外的不良事件隨訪,而最初隊列的安全跟進是分開的。該研究正在進行中,以收集接種後長達6個月的安全性和免疫原性數據,並預計於2025年結束。

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

NCT05921903是一項IIb期、隨機、對照、開放標籤、多國研究,旨在評估輝瑞公司RSV疫苗在免疫受損的成年人(年齡≥18歲)中的免疫反應和安全性,其中包括肺部和腎臟移植術後免疫受損的個體,比較單劑和雙劑(1劑,n=131,2劑,n=130),在第二次接種疫苗後一個月(30-42天),與一個對照組進行比較,該對照組是50歲及以上的非免疫受損成年人,接受輝瑞公司RSV疫苗單劑接種(n=125名50歲及以上的非免疫受損成年人)。在8個國家的48個地點招募了386名參與者。

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.

試驗的聯合主要終點是輝瑞公司RSV疫苗第一劑和第二劑後RSV-A和RSV-b中和滴定抗體滴度,表示爲第一劑後與第二劑後約一個月的均幾何增加比值。還有安全性和免疫原性的次要終點。該研究正在進行中,以收集更多安全性和免疫原性數據,直至最後一劑後12個月,並預計於2025年結束。

About GSK's RSV vaccine

關於輝瑞公司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,含有穩定的重組RSV F糖蛋白的前沿構象(RSVPreF3)。該抗原與輝瑞公司專有的AS01E佐劑結合。

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.

使用這種疫苗應遵循官方建議。與任何疫苗一樣,並非所有接種者都能產生免疫保護性反應。

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. 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.

這種疫苗已經獲得批准,在50多個國家,包括歐洲、日本和美國,用於預防60歲及以上人群中的RSV下呼吸道疾病。此外,已經在美國和歐盟/歐洲經濟區國家獲得批准,可用於處於特定潛在醫療條件導致的增加風險的50-59歲個體。其他國家,包括日本,也正在進行擴展適應症的監管審查。擬議的商標名稱仍需在其他市場獲得監管批准。

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專有的AS01佐劑系統含有從Agenus公司全資子公司Antigenics公司獲得許可的STIMULON QS-21佐劑。STIMULON是Agenus公司的子公司SaponiQx公司的商標。

About GSK

關於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是一家全球生物醫藥公司,其目的是通過聯合科學、技術和才華於疾病之前獲得優勢。詳情請訪問gsk.com。

Cautionary statement regarding forward-looking statements

關於前瞻性聲明的警示性聲明

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 2023, and GSK's Q2 Results for 2024.

GSk 提示投資者,GSk 在本公告中發表的任何前瞻性聲明或預測都存在風險和不確定性,可能導致實際結果與預期結果有所不同。 這些因素包括但不限於 GSK 的 2023 年年度報告表格 20-F 的第 3.D 條「風險因素」和 2024 年第二季度業績。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論