Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers’ diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala

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The Lancet Infectious Diseases
Mar 2014  Volume 14  Number 3   p173 – 256
http://www.thelancet.com/journals/laninf/issue/current

Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers’ diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala
Ronald H Behrens, Jakob P Cramer, Tomas Jelinek, Hilary Shaw, Frank von Sonnenburg, Darren Wilbraham, Thomas Weinke, David J Bell, Edwin Asturias, Hermann L Enkerlin Pauwells, Roberto Maxwell, Mercedes Paredes-Paredes, Gregory M Glenn, Shailesh Dewasthaly, Donald M Stablein, Zhi-Dong Jiang, Herbert L DuPont
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Although the LT antigen was delivered effectively by the skin patch, the vaccine did not protect travellers against diarrhoea caused by ETEC or other organisms. Future vaccines against travellers’ diarrhoea might need to include several antigens against various diarrhoeal pathogens, and might need to be able to generate mucosal and higher systemic immunity.