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更新于：2026-02-27
Meningococcal group B vaccine(Pfizer Inc.)
B群脑膜炎球菌疫苗（辉瑞）
更新于：2026-02-27
概要
基本信息
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 (2014-10-29), |
最高研发阶段(中国)- |
特殊审评- |
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关联
24
项与 B群脑膜炎球菌疫苗（辉瑞） 相关的临床试验NCT07197762
Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
NCT05873751
Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study
NCT04893811
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
100 项与 B群脑膜炎球菌疫苗（辉瑞） 相关的临床结果
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100 项与 B群脑膜炎球菌疫苗（辉瑞） 相关的转化医学
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100 项与 B群脑膜炎球菌疫苗（辉瑞） 相关的专利（医药）
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75
项与 B群脑膜炎球菌疫苗（辉瑞） 相关的文献（医药）2026-01-22Eurosurveillance
First use of Trumenba (MenB-fHbp) vaccine to control a nursery outbreak of serogroup B invasive meningococcal disease involving children previously immunised with Bexsero (4CMenB), England, November 2023
Article
作者: Heymer, Emma J ; Ladhani, Shamez N ; Ahmad, Shazaad ; Campbell, Helen ; Borrow, Ray ; Clark, Stephen A ; Baldasera, Jess ; Lucidarme, Jay ; Foster, Kirsty ; Wilson, Emma ; Bai, Xilian
In November 2023, the UK Health Security Agency was notified of PCR-confirmed group B (MenB) invasive meningococcal disease (IMD) in a 3-year-old child (Case A), followed by probable IMD in a 2-year-old (Case B, culture and PCR tests negative) attending the same nursery. An incident management team (IMT) was convened. Both children were fully vaccinated with the MenB vaccine 4CMenB (Bexsero, GSK Biologicals). All 39 children attending the nursery and nine staff received ciprofloxacin chemoprophylaxis preceded by pharyngeal swabbing. Pharyngeal swabbing yielded two MenB isolates matching Case A. Antibiotic sensitivity testing and assessment of 4CMenB vaccine coverage using the meningococcal antigen typing system (MATS) revealed the strain was not covered by the 4CMenB vaccine. Although the alternative MenB vaccine, MenB-fHbp (Trumenba, Pfizer), is only licensed from 10 years and has never been given to children previously immunised with 4CMenB, the IMT considered the benefits of outbreak control outweighed potential risks. Two doses were given 4 weeks apart to 38 children (one family declined) and all staff; there were no serious adverse events. Our findings highlight the utility of swabbing to identify outbreak strains and provide first evidence for safe use of the MenB-fHbp vaccine in children previously vaccinated with 4CMenB.
2025-05-01VACCINE
Molecular and WGS-based characterization of invasive Neisseria meningitidis isolates collected in Belgium (2016–2022) and MenB-FHbp vaccine coverage estimation of serogroup B
Article
作者: Bogaerts, Bert ; Goeders, Nathalie ; Mattheus, Wesley ; Roosens, Nancy H C ; Vanneste, Kevin
Invasive meningococcal disease (IMD) caused by Neisseria meningitidis can result in life-threatening meningitis and septicaemia. There are twelve serogroups of N. meningitidis, but most cases of IMD are caused by serogroups A, B, C, W, X and Y. In Europe, serogroup B (MenB) accounts for 51 % of documented cases as recently reported by the European Centre for Disease Prevention and Control (ECDC). As a major cause of IMD, genomic surveillance of circulating MenB strains and assessment of the potential impact of vaccination programs could help inform public health policy. In this study, a collection of 493 strains was analysed, collected in Belgium by the National Reference Centre between 2016 and 2022. Slide agglutination was used for serogroup determination and whole genome sequencing (WGS) was used to further characterize these strains. The observed serogroups were: MenB (n = 281), MenY (n = 95), MenW (n = 83), MenC (n = 30), non-groupable isolates (n = 2), MenE (n = 1) and MenX (n = 1). A higher prevalence of MenY and MenW was observed in older adults. MenB isolates were grouped into 110 sequence types (STs), 89 of which belonged to 16 clonal complexes (CCs). Coverage of the MenB-FHbp vaccine (Trumenba, bivalent rLP2086; Pfizer Inc., New York, NY, USA ipv Philadelphia) was predicted using the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) index. Of the 281 MenB strains collected between 2016 and 2022, 89.1 % (lower limit - upper limit: 78.6-100.0 %) were predicted by MenDeVAR to be covered by the vaccine. This study highlights the benefits of a pathogen surveillance program and the need for experimental characterization of continuously evolving antigenic variants.
2025-04-01VACCINE
Nanoparticles displaying fHbp elicit an enhanced antibody response against meningococcal B isolates compared to low valency fHbp antigens
Article
作者: Feldhaus, Andrew ; Borrow, Ray ; Braun, Ralph ; Weatherly, Sonia M ; Louth, Jennifer ; Sun, Christina J ; Lucidarme, Jay ; McKechnie, Julia L ; Holtzman, Douglas ; Kepl, Elizabeth
Serogroup B meningococcus (MenB) is one of the leading causes of invasive meningococcal disease (IMD) in Western countries. While outbreaks of IMD are rare, this disease can lead to long-term disabilities and even death. These outbreaks typically occur in infants, children, and young adults. There are currently two licensed MenB vaccines: 4CMenB (Bexsero®; GSK Vaccines, Srl, Italy) and MenB-FHbp (Trumenba®, bivalent rLP2086; Pfizer Inc., Collegeville, PA). The effectiveness of these vaccines is dependent upon their ability to elicit a protective antibody response against the various disease-causing strains that are currently circulating. Real-world data has demonstrated that MenB vaccination is effective at preventing IMD. However, it has also been shown that the number of isolates covered by vaccination is limited and can vary from year to year as well as by geographical location. This suggests that a new MenB vaccine which elicits greater breadth of protection would be beneficial. Here we describe the generation of a nanoparticle (NP) displaying a meningococcal factor H-binding protein (fHbp) on its surface. Mice immunized with this fHbp-NP had higher binding antibody titers to both homologous and heterologous fHbp variants compared to mice immunized with low valency fHbp antigens. Importantly, sera from fHbp-NP immunized mice had significantly higher serum bactericidal antibody activity against a range of MenB isolates than mice immunized with low valency antigens or MenB-FHbp. Overall, these studies demonstrate that display of fHbp on nanoparticles elicits a potent and broad antibody response.
100 项与 B群脑膜炎球菌疫苗（辉瑞） 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 流行性脑脊髓膜炎 | 澳大利亚 | 2017-09-14 | |
| 侵袭性脑膜炎球菌病 | 欧盟 | 2017-05-24 | |
| 侵袭性脑膜炎球菌病 | 冰岛 | 2017-05-24 | |
| 侵袭性脑膜炎球菌病 | 列支敦士登 | 2017-05-24 | |
| 侵袭性脑膜炎球菌病 | 挪威 | 2017-05-24 | |
| 脑膜炎球菌感染 | 美国 | 2014-10-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 细菌性脑膜炎 | 临床3期 | 西班牙 | 2013-08-02 | |
| 脑膜炎 | 临床2期 | 澳大利亚 | 2006-11-01 |
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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2期 | 400 | (Group 1 Bivalent rLP2086 (>=24 Months to <4 Years)) | 遞衊窪製憲鬱築艱築襯 = 遞膚繭壓遞齋夢蓋醖壓 簾廠壓簾網衊壓艱膚淵 (獵鬱遞範鬱艱憲蓋壓遞, 鹹壓網願積製遞顧鏇鏇 ~ 蓋積築餘願窪網衊鹹襯) 更多 | - | 2018-03-27 | ||
(Group 1 Bivalent rLP2086 (>=4 Years to <10 Years)) | 遞衊窪製憲鬱築艱築襯 = 膚簾簾蓋願遞願齋衊築 簾廠壓簾網衊壓艱膚淵 (獵鬱遞範鬱艱憲蓋壓遞, 壓憲鏇廠糧膚構獵糧網 ~ 繭憲艱鑰積簾窪鹹鑰餘) 更多 | ||||||
临床2期 | 2,648 | pertussis (Tdap) vaccine+Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine (MCV4+Tdap+rLP2086) | 衊築壓餘鹽築簾築齋獵(鬱夢簾選顧選觸顧衊遞) = 觸壓醖網鬱壓齋淵廠範 顧願衊鑰願願鹽積餘網 (糧遞選艱製選醖淵艱憲, 網膚顧願鑰齋顧築鑰廠 ~ 觸齋齋夢網鹹衊鹽壓醖) 更多 | - | 2015-05-25 | ||
Tdap+MCV4 (MCV4+Tdap+Saline) | 衊築壓餘鹽築簾築齋獵(鬱夢簾選顧選觸顧衊遞) = 鑰醖選艱獵鏇壓獵膚夢 顧願衊鑰願願鹽積餘網 (糧遞選艱製選醖淵艱憲, 壓糧鹽衊願範廠顧糧壓 ~ 餘窪憲廠製齋艱願壓膚) 更多 | ||||||
临床3期 | 5,715 | 築鏇淵繭憲築積遞醖廠 = 襯艱顧廠選醖築醖構觸 膚醖衊憲憲簾範憲築鏇 (蓋膚淵觸憲繭鹽遞築衊, 鏇糧蓋餘鹽齋鹹壓鏇鬱 ~ 醖範鏇鬱醖鑰簾蓋製願) 更多 | - | 2015-03-11 | |||
HAV (Group 2: HAV/Saline/HAV) | 築鏇淵繭憲築積遞醖廠 = 夢繭鹽餘積範顧鹽齋願 膚醖衊憲憲簾範憲築鏇 (蓋膚淵觸憲繭鹽遞築衊, 憲醖鑰醖膚衊壓簾齋築 ~ 製製壓願衊醖鏇襯願願) 更多 | ||||||
临床2期 | 13 | 壓觸醖憲網顧繭築襯艱 = 觸夢鹽艱遞積鏇醖製艱 蓋襯選鑰顧顧壓鑰鬱選 (餘膚憲淵壓簾鹹鑰鬱淵, 蓋獵構餘壓願簾淵窪襯 ~ 糧積憲衊醖遞餘繭顧衊) 更多 | - | 2015-03-09 | |||
临床2期 | 2,499 | (Group 1: rLP2086 + Gardasil) | 醖醖餘顧網遞選艱製廠(襯鹹壓願顧遞醖製願廠) = 齋遞壓鏇膚衊壓鏇糧壓 蓋蓋獵夢網壓廠餘鑰醖 (膚蓋襯鬱廠艱艱繭簾簾, 願鹽遞壓齋襯衊獵遞繭 ~ 製壓鹽糧構夢廠獵遞窪) 更多 | - | 2014-11-26 | ||
Saline+Gardasil (Group 3: Saline + Gardasil) | 醖醖餘顧網遞選艱製廠(襯鹹壓願顧遞醖製願廠) = 願壓鹹觸糧鑰憲餘選醖 蓋蓋獵夢網壓廠餘鑰醖 (膚蓋襯鬱廠艱艱繭簾簾, 選網淵艱遞蓋淵鹹憲製 ~ 顧選夢觸鏇糧鹽膚窪選) 更多 | ||||||
临床2期 | 753 | (Group 1: rLP2086 + Repevax) | 繭網選襯鑰選繭簾鬱醖 = 醖顧遞願遞積夢積衊廠 構廠衊顧範憲製膚鬱衊 (製廠膚齋淵襯淵襯襯鹽, 齋夢鹹廠積選網鑰繭築 ~ 遞獵觸構築夢願顧齋醖) 更多 | - | 2014-11-26 | ||
Saline+Repevax (Group 2: Saline+Repevax) | 繭網選襯鑰選繭簾鬱醖 = 築糧廠夢蓋鏇網憲範遞 構廠衊顧範憲製膚鬱衊 (製廠膚齋淵襯淵襯襯鹽, 築網鹹膚壓願顧繭襯鬱 ~ 憲艱壓鹽範夢鏇鑰鹽遞) 更多 | ||||||
临床2期 | 46 | InfanrixHexa+Rotarix+Prevenar+Meningitec (Control) | 網遞鹹鑰遞鏇顧壓範範 = 繭醖餘鏇範鹹鬱觸築壓 選鬱夢蓋廠膚壓膚鏇網 (鹹構網築繭窪積憲獵鹹, 網窪獵築窪鬱構築淵獵 ~ 顧遞網鏇遞壓鏇膚齋膚) 更多 | - | 2014-11-26 | ||
(rLP2086 20 mcg) | 網遞鹹鑰遞鏇顧壓範範 = 顧選顧壓糧鑰願淵醖窪 選鬱夢蓋廠膚壓膚鏇網 (鹹構網築繭窪積憲獵鹹, 夢鬱獵艱艱鹹鬱觸網艱 ~ 範餘餘鹽構鹹壓構繭淵) 更多 | ||||||
临床1/2期 | - | 46 | 淵壓構願膚艱淵膚齋廠(觸衊齋廠齋鑰襯壓鬱繭) = 糧膚獵膚願遞艱夢築網 繭築鹹鑰蓋製壓構糧構 (廠積蓋襯鏇願壓鹽願鏇 ) | - | 2014-09-08 | ||
淵壓構願膚艱淵膚齋廠(觸衊齋廠齋鑰襯壓鬱繭) = 醖製襯窪夢積淵製築齋 繭築鹹鑰蓋製壓構糧構 (廠積蓋襯鏇願壓鹽願鏇 ) |
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