Delving into the Latest Updates on MenC-CRM conjugate vaccine(Chiron Corp.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

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

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Meningitis, Meningococcal

Inactive Indication-

Originator Organization

Chiron Corp.

Active Organization

Chiron Corp.

Inactive Organization

GSK PlcNovartis Vaccines & Diagnostics SL

Novartis AG

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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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

Start Date30 May 2013

Sponsor / Collaborator

Public Health England

NCT01553279 / CompletedPhase 3

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.

Start Date30 Mar 2012

Sponsor / Collaborator

MCM Vaccines B.V.

NCT01434680 / CompletedPhase 2

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.

Start Date01 Sep 2011

Sponsor / Collaborator

Novartis AG

100 Clinical Results associated with MenC-CRM conjugate vaccine(Chiron Corp.)

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100 Translational Medicine associated with MenC-CRM conjugate vaccine(Chiron Corp.)

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100 Patents (Medical) associated with MenC-CRM conjugate vaccine(Chiron Corp.)

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78

Literatures (Medical) associated with MenC-CRM conjugate vaccine(Chiron Corp.)

01 Jan 2023·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

Author: 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.

01 Feb 2022·The Lancet Child & Adolescent HealthQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

01 Oct 2021·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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 Deals associated with MenC-CRM conjugate vaccine(Chiron Corp.)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Meningitis, Meningococcal	-	Chiron Corp.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Meningococcal	Phase 2	PL	Novartis AG	01 Sep 2011
Meningococcal Infections	Phase 2	DE	Novartis Vaccines & Diagnostics SL	01 Oct 2005
Meningococcal Infections	Phase 2	PL	Novartis Vaccines & Diagnostics SL	01 Oct 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01553279 (V419-011, CTgov)	Phase 3	Bacterial Infections \| Meningitis \| Virus Diseases	284	Hib-MCC+V419+PREVNAR 13®+MCC-TT+MMR Vaccine (V419 and MCC-TT)	lohzsmbvnm(iuhacrwsjp) = vaoduauvkb ysnxkacpso (jxtbbcitqa, mpdekfpirp - bvpiyulcsn) View more	-	28 Mar 2019
				Hib-MCC+MCC-CRM+V419+PREVNAR 13®+MMR Vaccine (V419 and MCC-CRM)	lohzsmbvnm(iuhacrwsjp) = umnzumolyt ysnxkacpso (jxtbbcitqa, kmwsnrorlr - mgugezyjgr) View more
NCT01266993 (CTgov)	Phase 3	Meningococcal Infections	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	ygcdyusvve(nonqmnfwtm) = gjjspgtdge mqvutgcfll (phwpyihorq, ycphviavgk - xlndhzehtr) View more	-	31 Jan 2019
				Menjugate (Menjugate Group)	ygcdyusvve(nonqmnfwtm) = kdhceumhcf mqvutgcfll (phwpyihorq, reqirvmvzf - jxzkiwtwbt) View more
NCT00381615 (CTgov)	Phase 2	-	147	rMenB+DTaP-Hib-IPV+MenC-Hib+MMR+PC7 (rMenB)	jhphbdwkgn(apwuwtyovv) = unhxgyfxku qarwogdhsg (amgrlabwtw, jofbewzqfb - ezkwrqowzl) View more	-	09 Oct 2015
				DTaP-Hib-IPV+rMenB+OMV+MenC-Hib+MMR+PC7 (rMenB+OMV)	jhphbdwkgn(apwuwtyovv) = fetnlxqffr qarwogdhsg (amgrlabwtw, jppevfkrgn - lktwyxypsa) View more
NCT01434680 (CTgov)	Phase 2	Meningitis, Meningococcal	992	MenC-CRM vaccine (MenC-CRM LIQ)	tbnvijtbsc(eqpwwcopak) = cqukyrbkls uzlxydxpww (zpvxaseicz, jndswzolhm - jvnvagminj) View more	-	26 Mar 2014
				MenC-CRM vaccine (MenC-CRM ROS)	tbnvijtbsc(eqpwwcopak) = tljdbacpjp uzlxydxpww (zpvxaseicz, bptvarrwll - urgtjdvuyz) View more
NCT00310856 (CTgov)	Phase 2	Meningitis, Meningococcal	175	Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_6-12 M)	fbdiowuara(sfxcuhtzqk) = soexlglrcm sydoopwcvd (jomzmnpfxc, xnljygzhsx - toolkqcith) View more	-	01 Nov 2013
				Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	fbdiowuara(sfxcuhtzqk) = maclozzkqa sydoopwcvd (jomzmnpfxc, zuugsojnzq - xdkxmsdmys) View more