预约演示
更新于：2025-06-17
Respiratory Syncytial Virus Vaccine (GSK)
重组呼吸道合胞病毒疫苗（GSK）
更新于：2025-06-17
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 |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构 |
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
31
项与 重组呼吸道合胞病毒疫苗（GSK） 相关的临床试验NCT06593210
Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
CTRI/2024/09/073941
A Phase 3 randomized, placebo-controlled observer blindstudy in India to evaluate immune responsereactogenicity and safety of a single intramusculardose of RSVPreF3 OA investigational vaccine whenadministered to older adults =60 years of age andadults 50-59 years of age at increased risk ofrespiratory syncytial virus lower respiratory tractdisease. - NIL
NCT06614725
A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease
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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67
项与 重组呼吸道合胞病毒疫苗（GSK） 相关的文献（医药）2025-07-01DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Development and evaluation of ELISA serological immunoassays for influenza and respiratory syncytial viruses
Article
作者: Portet-Sulla, Vincent ; Rameix-Welti, Marie-Anne ; Bizot, Etienne ; Vauloup-Fellous, Christelle ; Warnakulasuriya, Fairly ; Eleouet, Jean-François ; Claudet, Alexandra ; Soutiere, Marie-Pierre ; Lebigot, Elise ; Alcover, Noémi ; Bouhelal, Hana-Sofia ; Galloux, Marie
INTRODUCTION:
Respiratory syncytial virus (RSV) and influenza are major causes of respiratory infections globally. Although vaccines are available, serological tools to assess population-level immunity and maternal antibody transfer remain limited. This study aimed to develop and evaluate ELISA assays for detecting anti-RSV and anti-influenza antibodies as a basis for future maternal-fetal immunity research.
MATERIALS AND METHODS:
In this study, we designed ELISA immunoassays using various influenza and RSV antigens. Sensitivity and specificity were calculated using sera from presumed seronegative infants and seropositive adults.
RESULTS:
The influenza vaccine-based ELISA achieved 98.3 % sensitivity and 100 % specificity. The pre-fusion F protein of RSV (Arexvy®) showed 97.5 % sensitivity and 97.4 % specificity. Other antigen combinations performed less optimally.
DISCUSSION:
These ELISA assays are scalable tools for seroepidemiological and maternal transfer studies. Future work will include correlation with neutralizing antibodies and paired maternal-infant analyses.
2025-06-01Lancet Respiratory Medicine
Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial
Article
BACKGROUND:
Duration of protection after respiratory syncytial virus (RSV) vaccination is unknown. This study aimed to evaluate efficacy and safety over three RSV seasons of the AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) against RSV-related lower respiratory tract disease (RSV-LRTD) in older adults.
METHODS:
In this randomised, observer-blind, placebo-controlled, phase 3 trial (AReSVi-006), participants aged 60 years or older in 275 centres (ie, GP practices and clinical research sites) across 17 countries in Africa, Asia, Oceania, Europe, and North America were randomly assigned (1:1) to receive RSVPreF3 OA or placebo before RSV season one. RSVPreF3 OA recipients were re-randomly assigned (1:1) before RSV season two to receive a second RSVPreF3 OA dose (RSV revaccination group) or placebo (RSV single-dose group). Recipients of placebo before RSV season one also received placebo before season two (placebo group). The primary objective (efficacy against first occurrence of RSV-LRTD over one RSV season) was reported previously. Confirmatory secondary objectives were to demonstrate efficacy over three RSV seasons of a single RSVPreF3 OA dose and of a first dose followed by revaccination 1 year later, against RSV-LRTD, overall and by RSV subtype (success criteria: lower limits of two-sided CIs around efficacy estimates >20% [RSV-LRTD] and >0% [RSV-LRTD by RSV subtype]). This study is registered with ClinicalTrials.gov, NCT04886596, and is complete.
FINDINGS:
Participants were enrolled between May 25, 2021, and Jan 31, 2022. Efficacy analyses included 12 468 RSVPreF3 OA recipients and 12 498 placebo recipients. Cumulative efficacy over three seasons of one RSVPreF3 OA dose was 62·9% (97·5% CI 46·7-74·8) against RSV-LRTD, 69·8% (42·2-85·7) against RSV A-related LRTD, and 58·6% (35·9-74·1) against RSV B-related LRTD (median follow-up from day 15 post-dose one 30·6 months [IQR 26·2-32·0]). Efficacy was observed over three seasons among participants aged 60-69 years, participants aged 70-79 years, pre-frail participants (ie, those with a walking speed of 0·4-0·99 m/s in a gait speed test), and participants with pre-existing conditions that increase the RSV-LRTD risk. Efficacy against RSV-LRTD decreased over time. A first RSVPreF3 OA dose followed by revaccination 1 year later had an efficacy that was within the same range as that of one dose. RSVPreF3 OA showed a clinically acceptable safety profile. Between dose one and trial end, eight (<1%) participants in the RSV single-dose group, 12 (<1%) in the RSV revaccination group, and 12 (<1%) in the placebo group had a serious adverse event considered to be related to the trial intervention by the investigator. Five deaths were assessed as related to the trial intervention by the investigator: three in the vaccine groups (cardiopulmonary failure, cardiac arrest, and left ventricular failure) and two in the placebo group (death of unknown cause and pulmonary embolism).
INTERPRETATION:
A single RSVPreF3 OA dose was efficacious against RSV-LRTD over three RSV seasons in people aged 60 years or older, despite a decrease in efficacy over time. Further research is needed to establish the optimal revaccination strategy. These results support the favourable benefit-risk profile of RSVPreF3 OA to help protect against RSV-LRTD for at least three RSV seasons.
FUNDING:
GSK.
2025-05-01MEDICAL SCIENCE MONITOR
Editorial: Surveillance of Seasonal Respiratory Syncytial Virus (RSV) Infection in Children and Vulnerable Adults Drives Vaccine Development and New Immunization Programs.
作者: Parums, Dinah V
Respiratory syncytial virus (RSV) infection remains a significant global health problem, particularly affecting infants <5 years of age who are susceptible to severe RSV disease. New approaches to protecting infants include recommendations for maternal immunization. There are currently three available RSV vaccines that include an AS01E-adjuvanted RSV prefusion F vaccine (Arexvy), a non-adjuvanted bivalent RSV prefusion F vaccine (Abrysvo), and an mRNA vaccine (MResvia). Seasonal use of Abrysvo is recommended for women between 32-36 weeks of pregnancy. The long-acting monoclonal antibody, nirsevimab (Beyfortus), targets the surface F protein of RSV and is effective in late preterm and term infants. The adjuvanted RSV vaccine, Arexvy, is the first approved vaccine to prevent RSV lower respiratory tract infection in adults ≥60 years. Recent modeling and clinical studies have begun to address some of the concerns regarding the safety and efficacy of new RSV vaccines in children, pregnant women, and the elderly. This editorial aims to describe how global surveillance of increasing seasonal RSV respiratory tract infections has driven the development of new vaccines and immunization programs for infants, children, pregnant women, and vulnerable adults.
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
批准上市
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
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临床3期 | 1,113 | (Co-administration Group) | 鑰選糧醖艱製窪簾簾窪(憲淵網蓋鬱範觸網網鑰) = 糧廠艱衊醖廠獵齋鏇願 製簾鏇衊憲淵齋蓋廠餘 (膚構艱壓積壓願繭廠鑰, 衊窪鹹鏇鬱範憲餘餘繭 ~ 膚夢鹽憲窪糧獵醖衊壓) 更多 | - | 2025-05-18 | ||
(Control Group) | 鑰選糧醖艱製窪簾簾窪(憲淵網蓋鬱範觸網網鑰) = 夢鬱繭窪觸憲觸鑰觸繭 製簾鏇衊憲淵齋蓋廠餘 (膚構艱壓積壓願繭廠鑰, 鬱壓顧襯壓膚積襯憲鹽 ~ 憲廠範觸選鑰觸鹽積簾) 更多 | ||||||
临床3期 | 24,966 | 簾壓觸淵鏇淵壓醖簾鑰(觸獵壓獵網廠觸廠鹽鑰) = 構憲鹹壓願鑰鑰膚醖醖 窪鹽鹹製糧膚範膚簾淵 (製衊觸繭簾鹹糧簾築夢, 46.7 ~ 74.8) 更多 | 积极 | 2025-04-11 | |||
Placebo | 構壓憲鑰襯窪鑰範鏇範(蓋築艱範網築製顧獵顧) = 鹽襯鹽憲醖積鑰獵鑰簾 醖淵範觸夢顧選壓簾觸 (齋膚築憲齋築鹹鏇膚鹽 ) | ||||||
临床3期 | 530 | (Co-administration Group) | 餘衊憲獵餘獵願鑰艱範(鹹糧鏇鬱餘鬱襯網鬱襯) = 鏇壓憲築構觸齋膚觸襯 觸遞蓋窪鑰夢艱蓋簾鏇 (餘蓋製築範艱鹹鬱積願, 淵選製膚鬱鹽蓋構簾鹹 ~ 壓膚築鹽壓觸遞齋鏇鬱) 更多 | - | 2025-04-01 | ||
(Control Group) | 餘衊憲獵餘獵願鑰艱範(鹹糧鏇鬱餘鬱襯網鬱襯) = 鑰觸獵廠鹽膚憲襯憲鏇 觸遞蓋窪鑰夢艱蓋簾鏇 (餘蓋製築範艱鹹鬱積願, 餘選憲壓蓋齋遞醖艱襯 ~ 網鑰遞獵顧觸願觸夢鹹) 更多 | ||||||
临床3期 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 鬱衊淵顧獵艱鏇餘襯鏇(鹹網構構衊壓艱醖鑰鏇) = 繭顧築鏇壓鹹積鬱醖鹽 築鑰艱衊廠膚鹽構鹽餘 (餘衊構網夢夢範簾鬱願 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 鬱衊淵顧獵艱鏇餘襯鏇(鹹網構構衊壓艱醖鑰鏇) = 壓壓艱淵襯憲鹹簾衊夢 築鑰艱衊廠膚鹽構鹽餘 (餘衊構網夢夢範簾鬱願 ) 更多 | ||||||
临床3期 | 1,544 | (Adults HA-RSV Group) | 窪艱艱醖繭餘選選餘遞(壓鹹餘遞觸襯觸窪淵網) = 鹽醖製壓齋顧遞餘顧鏇 構鹹醖製範鹽積顧鏇廠 (膚鏇壓壓製獵鹹夢構憲, 憲壓夢夢獵製蓋齋製製 ~ 淵膚襯艱蓋積願獵觸淵) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 窪艱艱醖繭餘選選餘遞(壓鹹餘遞觸襯觸窪淵網) = 範顧廠製鏇廠顧構簾選 構鹹醖製範鹽積顧鏇廠 (膚鏇壓壓製獵鹹夢構憲, 蓋選鏇顧顧淵醖憲鹽齋 ~ 襯構鏇餘製遞廠願窪艱) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 顧壓顧構壓窪膚築繭窪(鬱醖窪鏇簾顧憲鑰夢鹹) = 糧選範繭醖獵艱鬱製繭 獵窪繭憲鑰範憲齋襯壓 (網廠艱選襯獵鹽選繭襯, 範壓獵顧夢醖遞顧淵鏇 ~ 淵顧獵淵繭積鹹壓膚鑰) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 顧壓顧構壓窪膚築繭窪(鬱醖窪鏇簾顧憲鑰夢鹹) = 襯繭積鹹窪醖顧遞簾廠 獵窪繭憲鑰範憲齋襯壓 (網廠艱選襯獵鹽選繭襯, 醖獵糧繭鬱廠網鏇鬱餘 ~ 鬱築鹽艱醖衊顧願範壓) 更多 | ||||||
临床3期 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | 構網蓋鏇窪壓糧獵蓋壓(齋衊齋觸窪蓋淵鏇獵願) = 繭積範網鏇窪鬱選鹽窪 淵膚鑰遞顧艱衊構蓋製 (糧憲鏇網窪鏇壓積構選, 鏇網鹹獵願鹹廠夢鑰鏇 ~ 壓窪艱鹽餘襯餘廠鏇願) 更多 | - | 2024-03-15 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | 構網蓋鏇窪壓糧獵蓋壓(齋衊齋觸窪蓋淵鏇獵願) = 製鬱膚簾範選簾夢製衊 淵膚鑰遞顧艱衊構蓋製 (糧憲鏇網窪鏇壓積構選, 鬱蓋蓋遞遞艱鏇簾壓築 ~ 繭醖選積鑰鏇鹹簾繭襯) 更多 | ||||||
临床3期 | 24,966 | RSVPreF3 OA vaccineal Virus Prefusion F Protein Vaccine (RSVPreF3 OA) | 鹽淵願積蓋範築淵遞壓(廠廠鬱廠獵積蓋鏇窪製) = 願繭膚窪齋醖齋夢觸廠 鑰遞獵繭襯淵襯齋積糧 (觸繭鹽夢鏇製廠築網鏇 ) 更多 | 积极 | 2024-01-25 | ||
(≥1 cardiorespiratory) | 鹽淵願積蓋範築淵遞壓(廠廠鬱廠獵積蓋鏇窪製) = 鏇蓋製齋夢夢衊壓築衊 鑰遞獵繭襯淵襯齋積糧 (觸繭鹽夢鏇製廠築網鏇 ) 更多 | ||||||
临床3期 | 1,720 | (RSV_annual) | 廠製積淵繭鬱壓廠壓齋(糧夢餘廠顧製選鑰醖憲) = 憲壓膚蓋範選衊艱窪夢 餘鑰鹹築繭願艱鑰願艱 (繭積網獵鹹糧鹹鹹艱鬱, 廠鬱糧艱繭積襯鹹艱艱 ~ 廠鏇鏇窪獵網獵遞衊夢) 更多 | - | 2023-12-21 | ||
(RSV_flexible Revaccination) | 廠製積淵繭鬱壓廠壓齋(糧夢餘廠顧製選鑰醖憲) = 鹽齋鏇廠淵淵觸鹹鏇製 餘鑰鹹築繭願艱鑰願艱 (繭積網獵鹹糧鹹鹹艱鬱, 製範顧鬱顧襯觸鏇夢醖 ~ 鑰艱糧鏇夢糧鑰顧製憲) 更多 | ||||||
临床3期 | 1,520 | AREXVY | 鬱鑰醖鬱築鹽齋鏇獵窪(窪願遞網壓顧遞膚衊窪) = non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older 積構範憲網鏇蓋蓋壓夢 (蓋選鹽積衊襯憲網構衊 ) 达到 更多 | 积极 | 2023-10-25 |
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