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

Vaccine. 2007 May 30;25(22):4392-400. doi: 10.1016/j.vaccine.2007.03.034. Epub 2007 Apr 4.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bacterial Toxins / metabolism
  • Cholera Toxin / immunology*
  • Cholera Toxin / metabolism
  • Diarrhea / microbiology
  • Diarrhea / prevention & control*
  • Double-Blind Method
  • Enterotoxins / metabolism
  • Escherichia coli / immunology
  • Escherichia coli Infections / microbiology
  • Escherichia coli Infections / prevention & control*
  • Escherichia coli Proteins / immunology*
  • Escherichia coli Proteins / metabolism
  • Escherichia coli Vaccines / administration & dosage*
  • Escherichia coli Vaccines / adverse effects
  • Escherichia coli Vaccines / therapeutic use
  • Female
  • Fimbriae Proteins / immunology*
  • Fimbriae Proteins / metabolism
  • Guatemala
  • Humans
  • Male
  • Mexico
  • Middle Aged
  • Travel
  • Treatment Outcome
  • Vaccines, Inactivated / administration & dosage*
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / therapeutic use


  • Bacterial Toxins
  • Enterotoxins
  • Escherichia coli Proteins
  • Escherichia coli Vaccines
  • Vaccines, Inactivated
  • colonization factor antigens
  • heat-labile enterotoxin, E coli
  • Fimbriae Proteins
  • Cholera Toxin