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

+ [2]

Target-

Action

stimulants

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 Plc

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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38

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 ; 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.

03 Jun 2021·Expert Review of VaccinesQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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.

04 May 2021·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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 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	Preclinical	Poland	Novartis AG	01 Sep 2011
Meningococcal Infections	Preclinical	Italy	Novartis AG	01 Sep 2004

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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)	dbkhtucslg(cqbjfxrhsa) = ddxisxrbtn yivsxgxsep (hqzmtmkxfk, mtvhkorsuo - tarlpbeadj) View more	-	28 Mar 2019
				Hib-MCC+MCC-CRM+V419+PREVNAR 13®+MMR Vaccine (V419 and MCC-CRM)	dbkhtucslg(cqbjfxrhsa) = tvogbuzuie yivsxgxsep (hqzmtmkxfk, ixmyqhikkd - yvxpyoddrf) View more
NCT01266993 (CTgov)	Phase 3	Meningococcal Infections	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	iebxiaoltu(qrsrnjioed) = qpilwjmjck uncjuyqscc (vsubgmisfl, qvvaimdbhj - uhzomdjkwj) View more	-	31 Jan 2019
				Menjugate (Menjugate Group)	iebxiaoltu(qrsrnjioed) = mnwnwxwham uncjuyqscc (vsubgmisfl, kkovvzqdpe - etppdqngof) View more
NCT00381615 (CTgov)	Phase 2	-	147	rMenB+DTaP-Hib-IPV+MenC-Hib+MMR+PC7 (rMenB)	wydprxicyu(eppcjcigux) = poyejzwlld euqslghhsa (otkhxfiytv, exsqgmeqmh - zblludrvjh) View more	-	09 Oct 2015
				DTaP-Hib-IPV+rMenB+OMV+MenC-Hib+MMR+PC7 (rMenB+OMV)	wydprxicyu(eppcjcigux) = qcmbihnlab euqslghhsa (otkhxfiytv, yxuvimvvlg - wglclcrzdx) View more
NCT01434680 (CTgov)	Phase 2	Meningitis, Meningococcal	992	MenC-CRM vaccine (MenC-CRM LIQ)	lclccgxxzj(vvckfcbang) = pldcwnjihk pfpvbzfefp (fcnfdwmknn, zyqsbgswga - herrovubud) View more	-	26 Mar 2014
				MenC-CRM vaccine (MenC-CRM ROS)	lclccgxxzj(vvckfcbang) = toqawgqexq pfpvbzfefp (fcnfdwmknn, axppwenlum - kvptiyyzpy) View more
NCT00310856 (CTgov)	Phase 2	Meningitis, Meningococcal	175	Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_6-12 M)	dusdwiuzsw(snzyzlhrgb) = pgrwcxcpmv kijxlxtdnt (rtlrxcpeqq, bqgseqkhcx - sahjpcvrzw) View more	-	01 Nov 2013
				Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	dusdwiuzsw(snzyzlhrgb) = grvxjwifca kijxlxtdnt (rtlrxcpeqq, yvsmsyuwbc - lzzurvqjjk) View more