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

David A. Sack, Janet Shimko, Olga Torres, August L. Bourgeois, Domingo Sanchez Francia, Björn Gustafsson, Anders Kärnell, Iréne Nyquist, Ann Mari Svennerholm

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)4392-4400
Number of pages9
JournalVaccine
Volume25
Issue number22
DOIs
StatePublished - May 30 2007

Keywords

  • Colonization factor antigens
  • Enterotoxigenic E. coli
  • Guatemala
  • Mexico
  • Oral vaccine
  • Travel
  • Travellers' diarrhoea
  • Vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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