Abstract

Mucosal administration of antigens is a global priority and is recommended by the 5th Framework Programme of the European Union. 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. Among the many molecules that have been tested to facilitate mucosal immunization, LTK63 and LTR72, two non toxic derivatives of E. coli enterotoxin obtained by site-directed mutagenesis, are among the most promising mucosal adjuvants. These molecules that derive entirely from research performed in Europe are safe and have been shown to act as mucosal adjuvants for many antigens deriving from different pathogens.

Here we propose to manufacture GMP lots of the two mucosal adjuvants 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.