Introduction
diarrhoea, death, ®, ETEC infection, heat-labile toxin
WEST, DIARRHOEAL DISEASES, CHOLERA
In low- and middle-income countries (LMICs), diarrhoeal diseases remain a major health problem and one of the most frequent causes of death amongst children under 5 years.At the beginning of an ETEC infection, the bacteria attach to the intestinal epithelium by means of their surface colonization factors (CFs) and start to multiply and produce either a cholera toxin (CT)-like heat-labile toxin (LT) or a heat-stable peptide toxin (ST) or both.Immune protection against ETEC diarrhoea is considered to be mainly mediated by locally produced secretory IgA (S-IgA) antibodies against CFs and LT. These antibodies can prevent diarrhoea by inhibiting intestinal bacterial colonization and toxin action.The most advanced oral ETEC vaccine candidate ETVAX® vaccine consists of three components: (i) a mixture of four inactivated recombinant Spurred on by the successful preceding research, we undertook OEV123, a Phase 2b double-blind, randomized controlled trial to study the safety, immunogenicity, diagnostic laboratory tools and efficacy of ETVAX® vaccine amongst a large group of Finnish travellers visiting Benin, West Africa. The present paper describes our research design, results of safety and tolerability as well as data on immunogenicity.