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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.

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /social sciences/sociology/demography/mortality
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug/vaccines

Call for proposal

FP7-HEALTH-2013-INNOVATION-2
See other projects for this call

Funding Scheme

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

Coordinator

ROYAL HOLLOWAY AND BEDFORD NEW COLLEGE
Address
Egham Hill University Of London
TW20 0EX Egham
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 873 440
Administrative Contact
Craig Bryce (Mr.)

Participants (4)

L2D SERVICES SARL
France
EU contribution
€ 534 900
Address
Boulevard Du Montparnasse 166
75014 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jonathan Kearsey (Dr.)
C.RIS PHARMA SARL
France
EU contribution
€ 1 489 150
Address
Parc Technopolitain Atalante
35400 Saint Malo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Pierrick Auvray (Dr.)
Q-BIOLOGICALS NV
Belgium
EU contribution
€ 1 021 262
Address
Technologiepark 4
9052 Gent
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Annie Van Broekhoven (Dr.)
FGK CLINICAL RESEARCH GMBH
Germany
EU contribution
€ 890 004,80
Address
Heimeranstrasse 35
80339 Munchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ina Ott (Ms.)