MenC-CRM conjugate vaccine(Chiron Corp.)(MenC-CRM conjugate vaccine(Chiron Corp.)) - 在研适应症：流行性脑脊髓膜炎_专利_临床

概要

基本信息

药物类型

预防性疫苗、类毒素疫苗、结合疫苗

别名

MenC-CRM conjugate vaccine、Meningococcal C-CRM197 conjugate vaccine、Meningococcal vaccine group C conjugate

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靶点-

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病其他疾病

在研适应症

流行性脑脊髓膜炎

非在研适应症-

原研机构

Chiron Corp.

在研机构

Chiron Corp.

非在研机构

GSK PlcNovartis Vaccines & Diagnostics SL

Novartis AG

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

13

项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的临床试验

EUCTR2012-005273-31-GB / Not yet recruiting临床3期IIT

A phase III/IV randomised open-label study and comparison of the immunogenicity and safety of a single adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine (Meningitec™, or Menjugate™, or NeisVac-C™, or Menitorix™), when given concurrently with an acellular pertussis-containing booster vaccine (Repevax™ or IPV-Boostrix™) - Multiboost - MCC plus pertussis booster in adolescents

开始日期2013-05-30

申办/合作机构

Public Health England

NCT01553279 / Completed临床3期

A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.

开始日期2012-03-30

申办/合作机构

MCM Vaccines B.V.

NCT01434680 / Completed临床2期

A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers

The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.

开始日期2011-09-01

申办/合作机构

Novartis AG

100 项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的临床结果

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100 项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的转化医学

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100 项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的专利（医药）

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78

项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的文献（医药）

2023-01-01·Vaccine

Systems analysis of human responses to an aluminium hydroxide-adsorbed TLR7 agonist (AS37) adjuvanted vaccine reveals a dose-dependent and specific activation of the interferon-mediated antiviral response

Article

作者: Volpini, Gianfranco ; Bardelli, Monia ; O'Hagan, Derek T ; Gonzalez-Lopez, Antonio ; Taccone, Marianna ; Tavarini, Simona ; De Intinis, Carlo ; Aprea, Susanna ; Blohmke, Christoph J ; Nuti, Sandra ; Didierlaurent, Arnaud M ; Medini, Duccio ; Faenzi, Elisa ; Sammicheli, Chiara ; Finco, Oretta ; Seidl, Claudia ; Buricchi, Francesca ; Borgogni, Erica ; Schiavetti, Francesca ; Brazzoli, Michela ; Bertholet, Sylvie ; Siena, Emilio ; Bechtold, Viviane ; D'Oro, Ugo ; Cardamone, Dario

The candidate Adjuvant System AS37 contains a synthetic toll-like receptor agonist (TLR7a) adsorbed to alum. In a phase I study (NCT02639351), healthy adults were randomised to receive one dose of licensed alum-adjuvanted meningococcal serogroup C (MenC-CRM₁₉₇) conjugate vaccine (control) or MenC-CRM₁₉₇ conjugate vaccine adjuvanted with AS37 (TLR7a dose 12.5, 25, 50 or 100 µg). A subset of 66 participants consented to characterisation of peripheral whole blood transcriptomic responses, systemic cytokine/chemokine responses and multiple myeloid and lymphoid cell responses as exploratory study endpoints. Blood samples were collected pre-vaccination, 6 and 24 h post-vaccination, and 3, 7, 28 and 180 days post-vaccination. The gene expression profile in whole blood showed an early, AS37-specific transcriptome response that peaked at 24 h, increased with TLR7a dose up to 50 µg and generally resolved within one week. Five clusters of differentially expressed genes were identified, including those involved in the interferon-mediated antiviral response. Evaluation of 30 cytokines/chemokines by multiplex assay showed an increased level of interferon-induced chemokine CXCL10 (IP-10) at 24 h and 3 days post-vaccination in the AS37-adjuvanted vaccine groups. Increases in activated plasmacytoid dendritic cells (pDC) and intermediate monocytes were detected 3 days post-vaccination in the AS37-adjuvanted vaccine groups. T follicular helper (Tfh) cells increased 7 days post-vaccination and were maintained at 28 days post-vaccination, particularly in the AS37-adjuvanted vaccine groups. Moreover, most of the subjects that received vaccine containing 25, 50 and 100 µg TLR7a showed an increased MenC-specific memory B cell responses versus baseline. These data show that the adsorption of TLR7a to alum promotes an immune signature consistent with TLR7 engagement, with up-regulation of interferon-inducible genes, cytokines and frequency of activated pDC, intermediate monocytes, MenC-specific memory B cells and Tfh cells. TLR7a 25-50 µg can be considered the optimal dose for AS37, particularly for the adjuvanted MenC-CRM₁₉₇ conjugate vaccine.

2022-02-01·The Lancet Child & Adolescent Health1区 · 医学

Impact of an adolescent meningococcal ACWY immunisation programme to control a national outbreak of group W meningococcal disease in England: a national surveillance and modelling study

1区 · 医学

Article

作者: Parikh, Sydel R ; Borrow, Ray ; Ramsay, Mary E ; Bai, Xilian ; Ladhani, Shamez N ; Andrews, Nick ; White, Joanne ; Lucidarme, Jay ; Edelstein, Michael ; Campbell, Helen

BACKGROUNDIn August, 2015, the UK implemented an emergency adolescent immunisation programme with the meningococcal ACWY conjugate vaccine to combat a national outbreak of meningococcal group W (MenW) disease due to a hypervirulent ST-11 complex strain, which is currently causing regional and national outbreaks worldwide. This immunisation programme specifically targeted adolescents aged 13-18 years, an age group with low disease incidence but high nasopharyngeal carriage, with the aim of interrupting transmission and providing indirect (herd) protection across the population. Here, we report the impact of the first 4 years of the programme in England.METHODSPublic Health England conducts meningococcal disease surveillance in England. Laboratory-confirmed cases of invasive meningococcal disease during the academic years 2010-11 to 2014-15 (Sept 1 to Aug 31) were used to predict post-vaccination trends, based on the assumption that cases would plateau 1 year after vaccine implementation (conservative scenario) or that cases would continue to rise for 4 years after vaccine implementation (extreme scenario). Vaccine uptake evaluated in August, 2019, was 37-41% in adolescents aged 18 years immunised in primary care and 71-86% in younger teenagers routinely vaccinated in school. Vaccine effectiveness was estimated with the indirect screening method.FINDINGSMenW and MenY cases plateaued within 12 months and then declined, while MenC cases remained low throughout. Significant reductions were observed among adolescents aged 14-18 years for MenW (incidence rate ratio [IRR] 0·35 [95% CI 0·17-0·76]) and MenY (0·21 [0·07-0·59]) cases, with a non-significant reduction in MenC cases (0·11 [0·01-1·01]). Based on conservative and extreme scenarios, 205-1193 MenW cases were prevented through the indirect effects of the programme and 25 through direct protection. For MenY, an estimated 60-106 cases were prevented through the indirect effects of the programme and 19 through direct protection. Ignoring any residual effect from an earlier MenC-containing vaccine, the overall vaccine effectiveness against MenCWY disease combined was 94% (95% CI 80-99).INTERPRETATIONA meningococcal immunisation programme specifically targeting adolescent carriers succeeded in rapidly controlling a national MenW outbreak, even with moderate initial vaccine uptake.FUNDINGPublic Health England.

2021-10-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

NMR characterization of a multi-valent conjugate vaccine against Neisseria meningitidis A, C, W, Y and Haemophilus influenzae b infections

3区 · 医学

Article

作者: Berti, Francesco

Physicochemical technologies are a powerful tool for the structural characterization of vaccine antigens both at bulk level as well as on the final formulation. High-field Nuclear Magnetic Resonance (NMR) spectroscopy has been found to be an extremely and robust tool for tracking the industrial process manufacturing of carbohydrate-based vaccines. I have applied NMR spectroscopy to the characterization of a penta-valent conjugate vaccine against Neisseria meninigitidis group A, C, W, Y (MenACWY) and Haemophilus influenzae type b (Hib) infections, constituted of capsule derived polysaccharide fragments independently conjugated to CRM₁₉₇ protein carrier (CRM-MenA, CRM-MenC, CRM-MenW, CRM-MenY, CRM-Hib). ¹H NMR has been used for the identity testing of the carbohydrate antigens and of the vaccine formulation. The application of NMR-based assays on multivalent conjugate vaccines looks to be a promising approach for identity and stability analyses useful for future vaccines development.

100 项与 MenC-CRM conjugate vaccine(Chiron Corp.) 相关的药物交易

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外链

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适应症	国家/地区	公司	日期
流行性脑脊髓膜炎	-	Chiron Corp.	-

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适应症	最高研发状态	国家/地区	公司	日期
流行性脑脊髓膜炎	临床2期	波兰	Novartis AG	2011-09-01
脑膜炎球菌感染	临床2期	德国	Novartis Vaccines & Diagnostics SL	2005-10-01
脑膜炎球菌感染	临床2期	波兰	Novartis Vaccines & Diagnostics SL	2005-10-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01553279 (V419-011, CTgov)	临床3期	细菌感染 \| 脑膜炎 \| 病毒感染	284	Hib-MCC+V419+PREVNAR 13®+MCC-TT+MMR Vaccine (V419 and MCC-TT)	憲簾遞構夢製製鹹網簾(廠窪觸膚糧襯願襯衊夢) = 遞蓋築壓範觸糧構範範範鬱構鬱製餘簾鹽鹽願 (鹹鹹壓襯鏇衊鏇選膚積, 鑰製艱繭選膚顧鏇鹽遞 ~ 廠鏇顧鏇構餘餘範繭鏇) 更多	-	2019-03-28
				Hib-MCC+MCC-CRM+V419+PREVNAR 13®+MMR Vaccine (V419 and MCC-CRM)	憲簾遞構夢製製鹹網簾(廠窪觸膚糧襯願襯衊夢) = 選鑰遞願製淵構醖築築範鬱構鬱製餘簾鹽鹽願 (鹹鹹壓襯鏇衊鏇選膚積, 憲選鹽觸鹽餘構構憲顧 ~ 築願憲齋齋觸襯醖簾壓) 更多
NCT01266993 (CTgov)	临床3期	脑膜炎球菌感染	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	範廠獵積蓋願積齋獵夢(顧糧製網積顧餘鑰積衊) = 夢淵淵淵壓膚膚鏇顧鑰鑰積膚構簾顧繭鏇鏇觸 (築鑰觸顧鏇糧製鹹鬱觸, 構憲衊膚積鑰獵鹹獵鬱 ~ 繭繭範鹽齋網蓋膚鹹願) 更多	-	2019-01-31
				Menjugate (Menjugate Group)	範廠獵積蓋願積齋獵夢(顧糧製網積顧餘鑰積衊) = 鬱糧鹽糧網膚範鑰網願鑰積膚構簾顧繭鏇鏇觸 (築鑰觸顧鏇糧製鹹鬱觸, 壓餘醖鹽壓鬱膚製齋襯 ~ 窪顧齋窪鏇廠醖製鏇衊) 更多
NCT00381615 (CTgov)	临床2期	-	147	rMenB+DTaP-Hib-IPV+MenC-Hib+MMR+PC7 (rMenB)	鹽鏇範衊蓋窪餘願淵夢(鏇鹹構膚製齋築窪網廠) = 簾繭憲鬱簾鹽憲淵築壓築蓋製醖鑰艱積醖壓網 (襯廠壓醖選餘廠選觸餘, 齋製構選築衊壓壓範窪 ~ 糧襯廠憲淵餘淵艱願簾) 更多	-	2015-10-09
				DTaP-Hib-IPV+rMenB+OMV+MenC-Hib+MMR+PC7 (rMenB+OMV)	鹽鏇範衊蓋窪餘願淵夢(鏇鹹構膚製齋築窪網廠) = 簾選網鏇鏇鹽餘襯鑰壓築蓋製醖鑰艱積醖壓網 (襯廠壓醖選餘廠選觸餘, 構餘齋夢鏇鹽繭壓網膚 ~ 蓋憲遞襯獵糧觸夢膚繭) 更多
NCT01434680 (CTgov)	临床2期	流行性脑脊髓膜炎	992	MenC-CRM vaccine (MenC-CRM LIQ)	齋網製糧襯繭糧壓艱憲(構構淵鑰構遞衊廠繭構) = 簾獵簾積築鏇鬱夢簾網淵襯製網繭蓋鏇獵鬱顧 (襯範選鹽夢廠憲範鹽襯, 鏇膚鏇觸蓋鹽廠製網顧 ~ 蓋衊構壓觸選窪齋夢繭) 更多	-	2014-03-26
				MenC-CRM vaccine (MenC-CRM ROS)	齋網製糧襯繭糧壓艱憲(構構淵鑰構遞衊廠繭構) = 網糧糧鹽糧獵膚壓窪鹽淵襯製網繭蓋鏇獵鬱顧 (襯範選鹽夢廠憲範鹽襯, 獵鑰範觸獵獵簾夢築鑰 ~ 淵網鏇淵餘顧選窪夢願) 更多
NCT00310856 (CTgov)	临床2期	流行性脑脊髓膜炎	175	Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_6-12 M)	壓網糧網壓獵觸糧壓餘(觸憲夢選構艱遞構遞構) = 網衊構顧鬱衊積願糧醖膚餘構網衊憲簾製構夢 (簾製願築獵觸鑰淵繭網, 糧觸遞網齋構衊齋鏇鬱 ~ 廠範鏇積範衊獵蓋襯襯) 更多	-	2013-11-01
				Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	壓網糧網壓獵觸糧壓餘(觸憲夢選構艱遞構遞構) = 壓憲艱齋夢簾齋構餘簾膚餘構網衊憲簾製構夢 (簾製願築獵觸鑰淵繭網, 網範鏇憲觸襯鹹繭餘襯 ~ 顧衊網鬱醖製窪襯願艱) 更多