CDVAX

Oral Vaccination against Clostridium difficile Infection

Coordinatore	ROYAL HOLLOWAY AND BEDFORD NEW COLLEGE    more  Organization address address: EGHAM HILL UNIVERSITY OF LONDON city: EGHAM postcode: TW20 0EX contact info Titolo: Mr. Nome: Craig Cognome: Bryce Email: send email Telefono: +44 01784 443844
Nazionalità Coordinatore	United Kingdom [UK]
Totale costo	7˙547˙624 €
EC contributo	5˙808˙756 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2013-INNOVATION-2
Funding Scheme	CP-FP
Anno di inizio	2013
Periodo (anno-mese-giorno)	2013-06-01   -   2016-05-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	ROYAL HOLLOWAY AND BEDFORD NEW COLLEGE  Organization address address: EGHAM HILL UNIVERSITY OF LONDON city: EGHAM postcode: TW20 0EX contact info Titolo: Mr. Nome: Craig Cognome: Bryce Email: send email Telefono: +44 01784 443844	UK (EGHAM)	coordinator	1˙873˙440.00
2	C.RIS PHARMA SARL  Organization address address: Parc Technopolitain Atalante city: SAINT MALO postcode: 35400 contact info Titolo: Dr. Nome: Pierrick Cognome: Auvray Email: send email Telefono: +33 299196970 Fax: 33299196971	FR (SAINT MALO)	participant	1˙489˙150.00
3	Q-BIOLOGICALS NV  Organization address address: TECHNOLOGIEPARK 4 city: GENT postcode: 9052 contact info Titolo: Dr. Nome: Annie Cognome: Van Broekhoven Email: send email Telefono: +32 475966070	BE (GENT)	participant	1˙021˙262.00
4	FGK CLINICAL RESEARCH GMBH  Organization address address: HEIMERANSTRASSE 35 city: MUNCHEN postcode: 80339 contact info Titolo: Ms. Nome: Ina Cognome: Ott Email: send email Telefono: 498989000000 Fax: 498989000000	DE (MUNCHEN)	participant	890˙004.80
5	L2D SERVICES SARL  Organization address address: BOULEVARD DU MONTPARNASSE 166 city: PARIS postcode: 75014 contact info Titolo: Dr. Nome: Jonathan Cognome: Kearsey Email: send email Telefono: +33 182285372 Fax: +33 182285379	FR (PARIS)	participant	534˙900.00

Mappa

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 Obiettivo del progetto (Objective)

Clostridium difficile infection (CDI) is a major threat to public health in the industrialised world, particularly in Europe. In many EU countries C. difficile now eclipses Methicillin resistant S. aureus (MRSA) with hospital acquired infection mortality exceeding that of MRSA by a factor of four. C. difficile is resistant to a wide range of antibiotics with hypervirulent and multiple drug resistant strains now emerging. Vaccines are under development, but all are injectable and as such will elicit only a systemic immune response whereas growing scientific evidence suggests that to effectively prevent infection mucosal immunity is critical. Further, full protection to CDI (primary infection and recurrence) requires anti-toxin antibody responses as well as decolonisation of C. difficile spores. Our approach will be to use a novel mucosal vaccine delivery system based on the use of inactivated Bacillus subtilis spores that express two different recombinant C. difficile antigens on their surface, a toxoid antigen and a unique spore colonisation factor. In vivo proof of concept studies has provided compelling evidence for their use in a robust oral vaccine to CDI. This project aims to construct and optimise B. subtilis spores expressing these two antigens and to undertake therapeutic development. Our approach will use inactivated, killed, spores and oral delivery addressing any ethical issues that might arise. A patent application has been filed protecting this unique oral spore vaccine approach. A consortium has been built of SMEs with the expertise to optimise the therapeutic product and address its safety and immunogenicity in both preclinical and phase I clinical studies. The project will enable a unique oral vaccine against C. difficile to be clinically validated. The expected outcome will be the implementation of this vaccine in further clinical trials as well as validation of a novel vaccine platform that is applicable to other bacterial and viral infections.