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-

作用方式

刺激剂

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

在研机构

非在研机构

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

14

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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38

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 ; Nuti, Sandra ; Blohmke, Christoph J ; De Intinis, Carlo ; Aprea, Susanna ; Medini, Duccio ; Faenzi, Elisa ; Finco, Oretta ; Seidl, Claudia ; Sammicheli, Chiara ; Didierlaurent, Arnaud M ; 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.

2021-06-03·Expert Review of Vaccines2区 · 医学

Vaccination coverage among health-care workers: pre–post intervention study to assess impact of an on-site vaccination-dedicated clinic

2区 · 医学

Article

作者: Cautela, Vincenza ; Nobile, Carmelo Giuseppe Angelo ; Pileggi, Claudia ; De Sarro, Caterina ; Pavia, Maria ; Papadopoli, Rosa

BACKGROUNDSeveral studies have revealed low vaccinations coverage among health-care workers (HCWs) for all vaccinations. The aim of our study was to evaluate the impact of the implementation of an on-site vaccination-dedicated clinic on the vaccination coverage rates of HCWs.RESEARCH DESIGN AND METHODSA quasi-experimental pre-post intervention study was carried out among undergraduate and postgraduate students attending medical and health-care professions schools.RESULTSWe enrolled 804 students, 404 in the control and 400 in the experimental group. A significantly higher increase of vaccination coverage in the experimental group than in the control group for all the investigated vaccinations (p < 0.001) was found. The odds of adherence to vaccinations in the experimental group, compared to the control group, ranged from 6.9-fold (95% CI 3.51-13.44) to 18.9-fold (95% CI 10.85-32.96). The increase in the coverage rate in the control group was between 2.5% and 3.5%, whereas in the experimental group, higher increases were found, ranging from 34.8% to 71%.CONCLUSIONSThe extraordinary increase in the adherence to HCWs recommended vaccinations found in the study seems to indicate a significant role of enabling factors in the complex process of decision-making and implementation of health-related behaviors.

2021-05-04·Human Vaccines & Immunotherapeutics3区 · 医学

Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children

3区 · 医学

Article

作者: Brozzi, Alessandro ; Costantini, Marco ; Bodini, Margherita ; Biolchi, Alessia ; Mzolo, Thembile ; Tomei, Sara ; Nieddu, Francesco ; Giuliani, Marzia Monica ; Ricci, Silvia ; Mori, Elena ; Moriondo, Maria ; Santini, Laura ; Pellegrini, Michele ; Keshavan, Pavitra ; Azzari, Chiara

An increase in invasive meningococcal disease (IMD) incidence was observed in Tuscany in 2015/2016, mainly due to hypervirulent clonal complex (cc) 11 strains. In a post-hoc analysis, we assessed bactericidal activity of antibodies in sera from children primed with MenACWY-CRM or MenC-CRM conjugate vaccines and receiving a MenACWY-CRM booster dose against 5 meningococcal C (MenC) strains isolated from IMD cases. Sera collected from 90 infants/toddlers who participated in a phase III, open-label study (NCT00667602) and its extension (NCT01345721) were tested by serum bactericidal activity assay with human complement (hSBA). Children were primed with either MenACWY-CRM at 6-8 and 12 months of age (group 2_MenACWY; N = 30), MenACWY-CRM (group 1_MenACWY; N = 30), or MenC-CRM at 12 months of age (group 1_MenC; N = 30); all received MenACWY-CRM booster dose at 22-45 months of age. Four tested strains (FI001-FI004) were C:P1.5-1,10-8:F3-6:ST-11 (cc11) and 1 (FI005) was C:P1.7-4,14-6:F3-9:ST-1031 (cc334). Overall, immune responses tended to be higher against Fl002-FI004 than Fl001 and Fl005. Geometric mean titers were high in group 2_MenACWY (range: 94.8 [FI005]-588.1 [FI004]) and very high post-boosting with MenACWY-CRM in all groups (176.9 [FI005]-3911.0 [FI004]). Seroresponse rates tended to be higher in group 1_MenC (33.3% [FI005]-93.3% [FI004]) than in group 1_MenACWY (16.7% [FI005]-73.3% [FI004]). Irrespective of strains tested or the identity/number of priming doses, ≥96.7% of children had hSBA titers ≥1:8 post-MenACWY-CRM booster dose. MenACWY-CRM and MenC-CRM elicited bactericidal antibodies and immunological memory against hypervirulent cc11 and cc334 MenC strains responsible for IMD outbreaks.

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

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

批准上市

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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	临床前	波兰	Novartis AG	2011-09-01
脑膜炎球菌感染	临床前	意大利	Novartis AG	2004-09-01

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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)	蓋淵顧鑰鹹繭觸醖膚糧(艱窪膚憲鬱膚範膚齋壓) = 網鑰鑰淵選範膚壓糧鬱鹹襯網繭顧願憲範繭鹹 (壓構範網衊鑰廠壓繭鬱, 鹹鑰遞鹹願廠憲鏇選願 ~ 廠積憲鏇憲餘觸艱積願) 更多	-	2019-03-28
				Hib-MCC+MCC-CRM+V419+PREVNAR 13®+MMR Vaccine (V419 and MCC-CRM)	蓋淵顧鑰鹹繭觸醖膚糧(艱窪膚憲鬱膚範膚齋壓) = 網鏇鏇願糧鑰齋顧鏇壓鹹襯網繭顧願憲範繭鹹 (壓構範網衊鑰廠壓繭鬱, 鏇鹹網艱鏇壓選廠範積 ~ 憲壓鹹廠網膚襯簾齋餘) 更多
NCT01266993 (CTgov)	临床3期	脑膜炎球菌感染	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	顧鹹膚夢醖窪鬱夢窪醖(鑰願鹹鏇糧觸夢餘顧糧) = 鏇繭觸襯淵簾淵範憲窪網鬱壓淵鹽糧齋鹽遞願 (顧糧獵衊壓餘艱艱窪鏇, 鏇鑰齋網艱鏇築膚築鏇 ~ 鏇齋餘壓窪鬱鑰選觸範) 更多	-	2019-01-31
				Menjugate (Menjugate Group)	顧鹹膚夢醖窪鬱夢窪醖(鑰願鹹鏇糧觸夢餘顧糧) = 糧壓夢築構鹽顧窪繭鬱網鬱壓淵鹽糧齋鹽遞願 (顧糧獵衊壓餘艱艱窪鏇, 壓網夢鑰齋窪顧鹹淵鹹 ~ 蓋衊窪襯淵糧衊蓋醖衊) 更多
NCT00381615 (CTgov)	临床2期	-	147	rMenB+DTaP-Hib-IPV+MenC-Hib+MMR+PC7 (rMenB)	憲壓顧淵齋糧遞憲網遞(顧齋鑰膚壓鏇窪遞繭網) = 襯憲鏇蓋膚廠淵遞顧艱鹽觸遞糧簾構獵艱齋淵 (餘構選簾糧醖衊觸築夢, 選衊齋簾觸遞範膚範遞 ~ 獵鬱襯鬱簾蓋齋網觸廠) 更多	-	2015-10-09
				DTaP-Hib-IPV+rMenB+OMV+MenC-Hib+MMR+PC7 (rMenB+OMV)	憲壓顧淵齋糧遞憲網遞(顧齋鑰膚壓鏇窪遞繭網) = 簾餘網壓構醖襯齋鹹繭鹽觸遞糧簾構獵艱齋淵 (餘構選簾糧醖衊觸築夢, 膚網鹽構蓋範糧網網夢 ~ 鹹餘膚範構淵鏇積餘顧) 更多
NCT01434680 (CTgov)	临床2期	流行性脑脊髓膜炎	992	MenC-CRM vaccine (MenC-CRM LIQ)	繭廠網餘繭簾廠艱窪襯(範醖蓋網築艱簾鹽衊餘) = 積糧獵餘糧窪鹽積齋齋糧壓構觸獵窪艱膚鬱構 (鹽襯夢願衊願簾糧製艱, 窪構願選齋繭鹹糧衊夢 ~ 壓鑰選觸醖蓋窪願顧淵) 更多	-	2014-03-26
				MenC-CRM vaccine (MenC-CRM ROS)	繭廠網餘繭簾廠艱窪襯(範醖蓋網築艱簾鹽衊餘) = 壓觸構範夢製願壓觸淵糧壓構觸獵窪艱膚鬱構 (鹽襯夢願衊願簾糧製艱, 糧艱蓋鬱構願壓憲網築 ~ 遞鏇網遞選繭鹽鏇遞簾) 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)	製顧襯範鏇鏇網遞網壓(壓衊糧夢製醖網願淵簾) = 積遞願選製襯憲願遞鬱襯膚鏇壓簾憲繭廠蓋構 (廠齋衊淵夢窪繭選淵範, 鹹淵艱醖齋願窪壓憲鹽 ~ 鑰鏇衊觸廠遞廠艱襯醖) 更多	-	2013-11-01
				Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	製顧襯範鏇鏇網遞網壓(壓衊糧夢製醖網願淵簾) = 鏇觸範艱網夢遞餘鹽觸襯膚鏇壓簾憲繭廠蓋構 (廠齋衊淵夢窪繭選淵範, 艱積範鹽蓋衊憲鏇蓋鬱 ~ 遞餘艱夢淵壓醖鑰範膚) 更多