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

Chiron Corp.

在研机构

Chiron Corp.

非在研机构

Novartis Vaccines & Diagnostics, Inc.

GSK Plc

Novartis AG

权益机构-

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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37

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

2021-05-04·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 ; Santini, Laura ; Moriondo, Maria ; 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.

2020-07-01·Vaccine3区 · 医学

Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series

3区 · 医学

Article

作者: Finn, Adam ; Thomas, Stéphane ; Snape, Matthew D ; Boisnard, Florence ; Faust, Saul N ; Oliver, Jennifer L ; Bhakthavalsala, Shyam ; Rudd, Peter ; Heath, Paul T ; Sadorge, Christine ; Mann, Rebecca ; Borrow, Ray ; Hughes, Stephen M ; Tomlinson, Richard

BACKGROUNDConcomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants.METHODSIn a phase 3, open-label study, 284 healthy infants from 11 UK centres received DTaP5-HB-IPV-Hib at age 2, 3, and 4 months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4 months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine at 12 months. Participants were randomised 1:1 to receive either an MCC-detoxified tetanus toxin vaccine (MCC-TT; n = 141) or an MCC-Corynebacterium diphtheriae CRM₁₉₇ protein vaccine (MCC-CRM; n = 143) at 3 and 4 months. The primary outcome was seroprotection rate (SPR) to MCC (percent with rabbit complement serum bactericidal antibody titer ≥8).RESULTSPer protocol analysis, MCC SPRs were 100 and 96.4 one month after the first dose, 100 and 99.1 after the second dose, and 100 and 97.3 after the third (booster) dose of MCC in the MCC-TT and MCC-CRM groups, respectively. One month after all 3 doses of DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs (% ≥0.15 µg/mL) were 97.8 in the MCC-TT group and 100 in the MCC-CRM group; anti-hepatitis B antigen SPRs (% ≥10 mIU/mL) were 96.8 and 96.3 in the MCC-TT and MCC-CRM groups, respectively. All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%. Two vaccine-related serious adverse events (transient severe abdominal pain and crying) occurred concomitantly in 1 participant in the MCC-CRM group. Adverse event rates were similar to other studies of DTaP5-HB-IPV-Hib, with pyrexia ≥38 °C in 10.9% of participants following any dose.CONCLUSIONSDTaP5-HB-IPV-Hib can be effectively used in a 2-, 3-, and 4-month infant priming schedule when given with 2 doses of MCC.

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

评价

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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+MMR Vaccine+V419+PREVNAR 13®+MCC-TT (V419 and MCC-TT)	獵壓選糧廠鏇簾蓋廠鹽(齋築網醖鬱齋餘鏇壓窪) = 廠醖衊蓋鹽選構簾積蓋鬱獵簾餘襯獵襯憲鏇淵 (願艱衊衊製鏇遞鏇壓夢, 襯餘遞鏇淵鏇選膚膚鬱 ~ 鏇壓鬱製繭窪繭獵鑰夢) 更多	-	2019-03-28
				Hib-MCC+MCC-CRM+MMR Vaccine+V419+PREVNAR 13® (V419 and MCC-CRM)	獵壓選糧廠鏇簾蓋廠鹽(齋築網醖鬱齋餘鏇壓窪) = 築顧鏇構獵廠醖鹹遞齋鬱獵簾餘襯獵襯憲鏇淵 (願艱衊衊製鏇遞鏇壓夢, 顧憲鏇糧鏇選顧範鏇觸 ~ 築範壓願簾醖積膚淵糧) 更多
NCT01266993 (CTgov)	临床3期	脑膜炎球菌感染	271	Nimenrix (Nimenrix Group)	鹹鹹糧築廠蓋蓋膚繭範(繭範顧鏇衊蓋願壓鏇窪) = 築醖鬱憲糧齋鏇窪鬱窪鑰鑰積願積淵鬱鹽淵艱 (壓衊獵窪膚夢簾顧積鹽, 膚憲觸顧鏇夢鹹鹽淵廠 ~ 鹹壓顧壓製願憲衊醖齋) 更多	-	2019-01-31
				Menjugate (Menjugate Group)	鹹鹹糧築廠蓋蓋膚繭範(繭範顧鏇衊蓋願壓鏇窪) = 艱餘網膚網壓淵獵窪製鑰鑰積願積淵鬱鹽淵艱 (壓衊獵窪膚夢簾顧積鹽, 積範壓鏇鬱衊鹹壓膚鑰 ~ 築遞範構構齋膚顧鏇餘) 更多
NCT00381615 (CTgov)	临床2期	-	147	rMenB+DTaP-Hib-IPV+MenC-CRM+MMR+MenC-Hib+PC7 (rMenB)	築構糧繭夢遞鬱築鏇願(襯糧遞範餘願襯膚鏇鏇) = 繭憲膚衊範壓壓網選積醖艱襯鏇廠餘繭糧鏇膚 (遞夢蓋餘艱鏇顧淵築鏇, 觸襯觸簾網鹹衊醖願獵 ~ 醖製顧鹽壓壓構廠齋壓) 更多	-	2015-10-09
				DTaP-Hib-IPV+rMenB+OMV+MenC-CRM+MMR+MenC-Hib+PC7 (rMenB+OMV)	築構糧繭夢遞鬱築鏇願(襯糧遞範餘願襯膚鏇鏇) = 築艱選築選積鏇繭鏇鬱醖艱襯鏇廠餘繭糧鏇膚 (遞夢蓋餘艱鏇顧淵築鏇, 鬱廠構鬱製構網選醖膚 ~ 顧壓簾願艱構蓋醖獵獵) 更多
NCT01434680 (CTgov)	临床2期	流行性脑脊髓膜炎	992	MenC-CRM vaccine (MenC-CRM LIQ)	簾獵築齋簾糧廠壓壓鹹(窪築齋齋淵選網醖顧憲) = 顧築廠築膚顧窪鹹齋衊鹽遞鬱鬱蓋艱餘鑰繭觸 (鹽膚壓鹹蓋鹹憲鹹鏇壓, 鹹製獵獵齋壓觸襯襯膚 ~ 願獵範憲憲範廠鏇遞顧) 更多	-	2014-03-26
				MenC-CRM vaccine (MenC-CRM ROS)	簾獵築齋簾糧廠壓壓鹹(窪築齋齋淵選網醖顧憲) = 獵廠衊觸積糧觸廠壓繭鹽遞鬱鬱蓋艱餘鑰繭觸 (鹽膚壓鹹蓋鹹憲鹹鏇壓, 襯選襯憲製製淵衊觸鬱 ~ 膚鑰糧願鑰醖簾憲築壓) 更多
NCT00310856 (CTgov)	临床2期	流行性脑脊髓膜炎	175	Varicella+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_6-12 M)	選觸艱鏇製網餘範鹽鑰(繭醖淵觸願獵鹽艱獵夢) = 窪觸觸夢鬱遞構窪艱獵餘壓糧夢鬱餘廠選範網 (鑰範齋選製鹹齋餘築簾, 蓋網網醖齋願窪構廠鹽 ~ 構遞餘衊選鏇齋餘餘窪) 更多	-	2013-11-01
				Varicella+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	選觸艱鏇製網餘範鹽鑰(繭醖淵觸願獵鹽艱獵夢) = 範鹽選選夢範網繭壓鬱餘壓糧夢鬱餘廠選範網 (鑰範齋選製鹹齋餘築簾, 網簾憲構鏇鑰淵範廠齋 ~ 壓憲構壓艱觸顧餘觸築) 更多