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Content archived on 2024-05-30

Oral Vaccination against Clostridium difficile Infection

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.

Fields of science (EuroSciVoc)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

FP7-HEALTH-2013-INNOVATION-2
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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

CP-FP - Small or medium-scale focused research project

Coordinator

ROYAL HOLLOWAY AND BEDFORD NEW COLLEGE
EU contribution
€ 1 873 440,00
Address
EGHAM HILL UNIVERSITY OF LONDON
TW20 0EX Egham
United Kingdom

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Region
South East (England) Surrey, East and West Sussex West Surrey
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data

Participants (4)

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