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

• Published in: The Lancet infectious diseases Vol. 14; no. 3; pp. 197 - 204
• Main Authors: Behrens, Ronald H, Cramer, Jakob P, Jelinek, Tomas, Shaw, Hilary, von Sonnenburg, Frank, Wilbraham, Darren, Weinke, Thomas, Bell, David J, Asturias, Edwin, Pauwells, Hermann L Enkerlin, Maxwell, Roberto, Paredes-Paredes, Mercedes, Glenn, Gregory M, Dewasthaly, Shailesh, Stablein, Donald M, Jiang, Zhi-Dong, DuPont, Herbert L
• Format: Journal Article
• Language: English
• Published: London Elsevier Ltd 01.03.2014; Lancet Publishing Group; Elsevier Limited
• Subjects: Administration, Cutaneous; Adolescent; Adult; Bacterial diseases; Bacterial diseases of the digestive system and abdomen; Bacterial Toxins - immunology; Biological and medical sciences; Developing Countries; Diaries; Diarrhea; Diarrhea - microbiology; Diarrhea - prevention & control; Double-Blind Method; Drug Delivery Systems; E coli; Enterotoxins - immunology; Escherichia coli; Escherichia coli - immunology; Escherichia coli Proteins - immunology; Escherichia coli Vaccines - administration & dosage; Escherichia coli Vaccines - adverse effects; Europe; Female; Guatemala; Human bacterial diseases; Humans; Immunization; Immunization - methods; Infectious Disease; Infectious diseases; Male; Medical research; Medical sciences; Mexico; Middle Aged; Pathogens; Population; Toxins; Travel; Vaccines; Young Adult; Guatemala; Central America; Mexico; Europe; America; Escherichia coli; Vaccine; Infection; Prevention; Immunoprophylaxis; Toxin; Traveler diarrhea; Double blind study; Bacteria; Digestive diseases; Intestinal disease; Patch; Enterobacteriaceae

Enterotoxigenic Escherichia coli (ETEC) is a major cause of travellers' diarrhoea. We investigated the efficacy and safety of a skin-patch vaccine containing the pathogen's heat-labile toxin (LT) in a population of travellers to Mexico and Guatemala. In this phase 3, randomised, double-bli...