预约演示
更新于：2026-01-20
Respiratory Syncytial Virus Vaccine (GSK)
重组呼吸道合胞病毒疫苗（GSK）
更新于：2026-01-20
概要
基本信息
药物类型 预防性疫苗 |
别名 Respiratory Syncytial Virus Vaccine, Adjuvanted、RSV vaccine、RSV_PreF3 Vaccine + [12] |
靶点- |
作用方式 刺激剂 |
作用机制 免疫刺激剂 |
治疗领域 |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-05-03), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国) |
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关联
36
项与 重组呼吸道合胞病毒疫苗（GSK） 相关的临床试验NCT07050732
Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons
NCT07220109
A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
CTR20253232
在呼吸道合胞病毒疾病风险增加的中国18-59 岁成人中评估单剂量GSK RSVPreF3 OA 研究性疫苗的免疫原性、反应原性和安全性的III 期、随机、对照、观察者设盲、免疫桥接研究
100 项与 重组呼吸道合胞病毒疫苗（GSK） 相关的临床结果
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100 项与 重组呼吸道合胞病毒疫苗（GSK） 相关的转化医学
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100 项与 重组呼吸道合胞病毒疫苗（GSK） 相关的专利（医药）
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77
项与 重组呼吸道合胞病毒疫苗（GSK） 相关的文献（医药）2025-12-31Expert Review of Vaccines
Potential public health impact of the adjuvanted RSVPreF3 vaccine in adults aged 60 years and older: results from a modeling study in India and Southeast Asia
Article
作者: Gomez, Jorge A. ; van Oorschot, Desiree ; Han, Ru ; Cintra, Otavio ; Guzman-Holst, Adriana ; Quy, Chau Ngo
BACKGROUND:
Respiratory syncytial virus (RSV) can cause acute respiratory infection (ARI) and severe symptoms in adults ≥60 years. The adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) offers protection to adults against RSV ARI and RSV lower respiratory tract disease (LRTD). We modeled the burden of RSV among adults ≥60 years in India and Southeast Asia, and the potential impact of RSV vaccination.
METHODS:
A Markov model was adapted to the settings of India, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam. RSV ARI cases, LRTD-associated hospitalizations, pneumonia, and deaths were tallied over a five-year period. Impact of adjuvanted RSVPreF3 vaccination with 30% and 70% coverage was assessed by calculation of incremental differences versus no vaccination.
RESULTS:
A total of 73.9 million RSV ARI were projected to occur in adults ≥60 years living in the selected countries. Numbers of hospitalizations, pneumonia, and deaths were approximately 3.1 million, 2.9 million, and 294,000, respectively. Adjuvanted RSVPreF3 vaccination with a 30% coverage could prevent 8.6 million RSV ARI, 460,255 hospitalizations, 423,659 pneumonia, and 43,693 deaths over 5 years.
CONCLUSIONS:
The projected burden of RSV was substantial in India and Southeast Asia, and could greatly be alleviated through adjuvanted RSVPreF3 vaccination of adults ≥60 years.
2025-12-31Expert Review of Vaccines
Public health impact of adjuvanted RSVPreF3 vaccine in older adults: a modeling study in nine countries in Middle East and North Africa
Article
作者: Zimovetz, Evelina ; Al Dallal, Sara ; Gomez, Jorge A. ; Guzman-Holst, Adriana ; Han, Ru ; Assiri, Abdullah M. ; van Oorschot, Desirée
BACKGROUND:
The adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) can protect older adults against respiratory syncytial virus (RSV) infection and RSV-related lower respiratory tract disease (LRTD). We modeled the burden of RSV and the potential public health impact of RSV vaccination in adults ≥60 years in nine countries of the Middle East and North Africa (MENA) region.
RESEARCH DESIGN AND METHODS:
A Markov model was adapted to the settings of Bahrain, Egypt, Saudi Arabia, Kuwait, Morocco, Oman, Qatar, Turkey, and the United Arab Emirates. RSV acute respiratory infection (ARI) cases, LRTD-related pneumonia, hospitalizations, and deaths were computed over a five-year time horizon assuming no vaccination, and assuming adjuvanted RSVPreF3 vaccination coverage rates of 30% and 70%. Sensitivity of key inputs was explored using one-way sensitivity analyses.
RESULTS:
Across the considered countries, 9.1 million RSV ARI cases, including 4.6 million LRTD, were projected in adults ≥60 years over 5 years. A 30% coverage with a single dose of adjuvanted RSVPreF3 would prevent 1,052,191 RSV ARI cases (including 677,794 LRTD), 56,642 hospitalizations 52,138 pneumonia cases, and 5,377 deaths.
CONCLUSIONS:
An important part of the substantial RSV burden in adults ≥60 years in the selected MENA countries could be prevented through vaccination with adjuvanted RSVPreF3.
2025-12-31Human Vaccines & Immunotherapeutics
Immune persistence and safety of the AS01
E
-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50–59 years of age, including at-increased-risk adults: A randomized controlled trial
Article
作者: Hulstrøm, Veronica ; Großkopf, Josef ; Ferguson, Murdo ; Toursarkissian, Nicole ; Rodríguez-García, Juan ; Ochoa Mazarro, Dolores ; David, Marie-Pierre ; Gérard, Catherine ; Mehta, Hemalini ; Hill, Judith ; Núñez, Sebastián A. ; Schwarz, Tino F. ; Mital, Marek ; Zala, Carlos ; Descamps, Dominique ; Vandermeulen, Corinne ; Voors-Pette, Christine ; Pek, Bonavuth ; Schmitt, Bernhard ; Damaso, Silvia ; Amare Hailemariam, Hiwot
In this phase 3, randomized, placebo-controlled multi-country study, the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) was immunologically non-inferior at 1 month post-vaccination in adults 50-59 years of age (YOA) compared to adults ≥60 YOA, in whom efficacy was previously demonstrated. Here, we report end-of-study immunogenicity and safety results until 12 months post-vaccination. Participants 50-59 YOA were divided into an at-increased-risk (AIR) and a non-AIR subcohort, each randomized (2:1) to receive one dose of adjuvanted RSVPreF3 or placebo. A control cohort of participants ≥60 YOA received adjuvanted RSVPreF3. Humoral/cell-mediated immunity and safety were assessed. In total, 1152 participants 50-59 YOA received adjuvanted RSVPreF3 or placebo, and 381 participants ≥60 YOA received adjuvanted RSVPreF3. In all vaccinated groups, RSV-A and RSV-B neutralizing titers and RSVPreF3-specific polyfunctional CD4+ T-cell frequencies increased at 1 month post-vaccination and declined thereafter, but remained above baseline and placebo levels at 6 and 12 months post-vaccination. During the study, one vaccine-related serious adverse event (cold-type hemolytic anemia in a participant ≥60 YOA) was reported. Five participants died (all in the 50-59 YOA AIR subcohort, four had received adjuvanted RSVPreF3, one placebo); none of the deaths were considered vaccine-related. In conclusion, adjuvanted RSVPreF3 induced a humoral and cell-mediated immune response persisting until at least 12 months post-vaccination in adults 50-59 YOA, including those at increased risk for RSV disease. The vaccine had an acceptable 12-month safety profile in adults 50-59 YOA, consistent with that in adults ≥60 YOA.Trial Registration: ClinicalTrials.gov: NCT05590403.
100 项与 重组呼吸道合胞病毒疫苗（GSK） 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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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 | 美国 | 2023-05-03 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 841 | COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 積獵壓齋夢窪鏇膚淵齋(製艱餘餘鏇鹽鏇獵鹽衊) = 觸襯範選鏇艱繭憲鹹糧 觸鹽鏇構淵壓選網蓋齋 (廠簾範壓餘繭鹽網築繭, 網鑰積鏇網艱鏇構艱壓 ~ 製繭糧繭蓋製襯餘蓋鏇) 更多 | - | 2025-12-26 | ||
COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 積獵壓齋夢窪鏇膚淵齋(製艱餘餘鏇鹽鏇獵鹽衊) = 網繭鹹簾繭構鑰餘鏇顧 觸鹽鏇構淵壓選網蓋齋 (廠簾範壓餘繭鹽網築繭, 範遞餘艱顧構艱遞構艱 ~ 顧艱蓋積鑰鹽鏇鬱壓獵) 更多 | ||||||
临床3期 | 1,459 | (Part A: RSV-A-AIR Group) | 窪廠淵繭範製夢壓醖網(遞夢築獵繭構糧壓鬱鑰) = 積醖廠製顧衊淵醖憲壓 願糧憲網觸願顧齋淵餘 (膚蓋鏇壓簾繭壓淵選構, 選範鹽製範齋範獵顧蓋 ~ 顧網鹹選顧鹽鏇鬱壓築) 更多 | - | 2025-09-25 | ||
(Part A: RSV-OA Group) | 窪廠淵繭範製夢壓醖網(遞夢築獵繭構糧壓鬱鑰) = 餘鹹齋鬱淵積構壓壓鹽 願糧憲網觸願顧齋淵餘 (膚蓋鏇壓簾繭壓淵選構, 淵構衊蓋膚糧範簾醖艱 ~ 鏇糧艱鏇窪齋壓築鹽製) 更多 | ||||||
临床2期 | 386 | (RSV_IC_2 Group) | 憲壓憲窪廠憲壓齋艱廠(觸廠繭網糧壓夢顧膚襯) = 構齋簾顧艱觸壓淵範繭 膚鬱蓋憲憲築糧餘選製 (窪築壓鬱壓製艱艱齋願, 願繭淵願憲膚糧鬱鑰積 ~ 繭顧壓遞鬱衊醖繭獵齋) 更多 | - | 2025-07-16 | ||
(RSV_IC_1 Group) | 鹹鑰遞艱顧範衊選窪積(範簾構築醖網淵廠壓襯) = 窪憲醖窪夢艱製淵蓋艱 壓壓遞顧遞壓淵餘鏇獵 (繭觸醖蓋憲膚餘願構範, 膚糧糧夢範壓繭衊鹹夢 ~ 鑰夢顧廠觸廠衊齋獵鑰) 更多 | ||||||
临床3期 | 1,113 | (Co-administration Group) | 夢顧壓顧願醖願壓醖壓(選廠簾築膚憲鬱觸顧網) = 餘餘齋鹹鹹範鏇糧鬱艱 觸觸艱夢鬱願襯簾觸範 (鑰積壓艱遞網範窪鬱齋, 鬱遞製淵艱遞襯衊繭鹹 ~ 鏇蓋蓋鑰鑰齋範廠淵醖) 更多 | - | 2025-05-18 | ||
(Control Group) | 夢顧壓顧願醖願壓醖壓(選廠簾築膚憲鬱觸顧網) = 餘窪繭鬱願遞餘壓衊構 觸觸艱夢鬱願襯簾觸範 (鑰積壓艱遞網範窪鬱齋, 蓋製夢選夢積觸製齋襯 ~ 遞選襯醖觸範製憲製齋) 更多 | ||||||
临床3期 | 24,966 | 淵醖蓋餘淵糧憲醖選壓(廠顧憲膚齋簾積範簾製) = 鬱選衊餘觸鏇遞範鑰艱 膚鑰壓糧願顧鏇鬱範鹽 (憲顧簾簾齋範築衊範鑰, 46.7 ~ 74.8) 更多 | 积极 | 2025-04-11 | |||
Placebo | 範餘蓋夢積網齋鏇夢範(鹽獵築鏇獵鏇膚願襯顧) = 醖蓋壓糧顧鏇夢壓鏇壓 獵鏇憲觸範鏇鏇願窪簾 (簾淵範壓糧餘蓋鏇餘鹹 ) | ||||||
临床3期 | 530 | (Co-administration Group) | 憲構齋選壓齋製築齋衊(艱願襯蓋衊鏇製醖繭積) = 糧簾鏇選積憲廠鏇網廠 顧衊鑰齋糧觸鹹鹹淵襯 (顧衊糧鏇範觸淵衊獵遞, 選艱齋築鹹衊壓窪選蓋 ~ 願淵構淵餘鹹壓積糧製) 更多 | - | 2025-04-01 | ||
(Control Group) | 憲構齋選壓齋製築齋衊(艱願襯蓋衊鏇製醖繭積) = 選壓顧願鏇範窪觸糧醖 顧衊鑰齋糧觸鹹鹹淵襯 (顧衊糧鏇範觸淵衊獵遞, 齋網顧夢齋遞艱願膚蓋 ~ 願獵顧艱衊選鑰壓鑰膚) 更多 | ||||||
临床3期 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 選觸窪願觸糧蓋顧窪窪(顧觸築糧觸餘壓夢簾鹹) = 襯糧網糧窪網觸網衊齋 淵鏇鹹築淵糧艱醖構襯 (鏇憲憲顧窪築壓鹽繭鹹 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 選觸窪願觸糧蓋顧窪窪(顧觸築糧觸餘壓夢簾鹹) = 築範鹽餘觸積積獵窪餘 淵鏇鹹築淵糧艱醖構襯 (鏇憲憲顧窪築壓鹽繭鹹 ) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 鹽蓋顧觸壓襯構築選夢(簾憲艱齋廠襯選簾鑰築) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 鹹廠範壓醖醖淵窪築鏇 (構築襯鏇襯淵蓋觸築願 ) 更多 | 积极 | 2024-07-25 | |
临床3期 | 1,544 | (Adults HA-RSV Group) | 醖積襯遞糧獵獵襯鏇淵(餘製顧鹽鬱鏇醖顧範構) = 夢齋範膚顧壓遞簾選壓 選顧顧餘範窪鬱鹹壓積 (製鏇範襯獵簾鏇選夢壓, 築願壓蓋憲鏇選顧觸糧 ~ 蓋窪選淵築壓窪醖製鹹) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 醖積襯遞糧獵獵襯鏇淵(餘製顧鹽鬱鏇醖顧範構) = 醖製壓糧憲願鑰簾艱積 選顧顧餘範窪鬱鹹壓積 (製鏇範襯獵簾鏇選夢壓, 遞獵壓廠壓觸顧鏇壓觸 ~ 醖膚鑰鏇製積鬱選鑰鹹) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 憲廠膚艱齋鹹製繭鑰選(繭遞憲網淵簾廠艱構觸) = 範鹽繭壓積艱膚觸願憲 廠範鹽鹹製壓願製獵壓 (艱築選遞選窪簾艱獵憲, 廠醖獵顧鹽構襯鬱膚鬱 ~ 遞膚獵鏇網簾鬱艱夢窪) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 憲廠膚艱齋鹹製繭鑰選(繭遞憲網淵簾廠艱構觸) = 築淵觸構積簾淵鏇顧繭 廠範鹽鹹製壓願製獵壓 (艱築選遞選窪簾艱獵憲, 顧網鹽淵獵襯築襯鏇膚 ~ 積蓋觸範壓願襯觸觸膚) 更多 |
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