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Randomised, double-blind, safety and efficacy of a killed oral vaccine for enterotoxigenic E. Coli diarrhoea of travellers to Guatemala and Mexico

Review article
Authors D. A. Sack
J. Shimko
Olga Torres
A. L. Bourgeois
D. S. Francia
B. Gustafsson
Anders Kärnell
Iréne Nyquist
Ann-Mari Svennerholm
Published in Vaccine
Volume 25
Issue 22
Pages 4392-400
Publication year 2007
Published at Institute of Biomedicine, Department of Microbiology and Immunology
Pages 4392-400
Language en
Keywords Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Bacterial Toxins/metabolism, Cholera Toxin/*immunology/metabolism, Colicins/*immunology/metabolism, Diarrhea/microbiology/*prevention & control, Double-Blind Method, Enterotoxins/metabolism, Escherichia coli/immunology, Escherichia coli Infections/microbiology/*prevention & control, Escherichia coli Proteins/*immunology/metabolism, Escherichia coli Vaccines/*administration & dosage/adverse, effects/therapeutic use, Female, Guatemala, Humans, Male, Mexico, Middle Aged, Travel, Treatment Outcome, Vaccines, Inactivated/*administration & dosage/adverse effects/therapeutic, use
Subject categories Medical and Health Sciences


We tested the efficacy of a killed oral vaccine for enterotoxigenic Escherichia coli (ETEC) diarrhoea to determine if two doses of vaccine with colonization factor antigens (CF) and cholera B subunit would protect against ETEC diarrhoea of travellers. Six hundred seventy-two healthy travellers going to Mexico or Guatemala were studied in a prospective, randomised, placebo-controlled trial. The primary outcome was a vaccine preventable outcome (VPO), defined as an episode of ETEC diarrhoea with an ETEC organism producing heat labile toxin (LT) or CF homologous with the vaccine, without other known causes. The vaccine was safe and stimulated anti-heat labile toxin antibodies. There was a significant decrease in more severe VPO episodes (PE=77%, p=0.039) as defined by symptoms that interfered with daily activities or more than five loose stools in a day, although the total number of VPO events did not differ significantly in the vaccine and placebo groups. We conclude that the new oral ETEC vaccine reduces the rate of more severe episodes of traveller's diarrhoea (TD) due to VPO-ETEC, but it did not reduce the overall rate of ETEC diarrhoea or of travellers' diarrhoea due to other causes.

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