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Vaccines and Correlates of Protection

Prove the Mucosal Adjuvanticity of LT Mutants with Influenza Antigens for FOR Intranasal Immunisation

EC contribution
: € 1 003 359
: 36 months
Starting date
: 01/02/2000
: Shared Cost Action
: Control of infectious diseases, pre-clinical development of vaccines, transdisease vaccinology
Project Number
: QLK2-CT-1999-00070


Mucosal administration of antigens is a global priority. Many approaches have been adopted to develop vaccines that can be delivered without using syringes and that induce immune response at the mucosal sites that are often the portal of entry of pathogens. Here we propose to manufacture GMP lots of the mucosal adjuvants LTK63 and LTR72, two non-toxic derivatives of E. coli enterotoxin obtained by site-directed mutagenesis, and to test them in a clinical setting in human adult volunteers to obtain proof of concept that these molecules can be effectively used to adjuvant mucosal vaccines for human use. As a model, for this demonstration project we have chosen the influenza vaccine for intranasal administration.


Delivery of vaccines by mucosal route is one of the major goals of today's research. The advantage of easier delivery combined with the possibility of neutralising pathogens at their portal of entry have made mucosal immunisation one of the major targets of the European Union, WHO and the US NIH. Furthermore, mucosal delivery by eliminating the use of syringes would increase compliance and decrease the risk of spread of infectious diseases that has been reported by improper use of syringes during vaccination.

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