Randomised, double-blind, safety and efficacy of a killed oral vaccine for enterotoxigenic E. Coli diarrhoea of travellers to Guatemala and Mexico.
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.
Sack
David A
DA
Vaccine Testing Unit, Johns Hopkins University, Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. dsack@icddrb.org
Shimko
Janet
J
Torres
Olga
O
Bourgeois
August L
AL
Francia
Domingo Sanchez
DS
Gustafsson
Björn
B
Kärnell
Anders
A
Nyquist
Iréne
I
Svennerholm
Ann-Mari
AM
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001427:Bacterial Toxins / Q000378:metabolism; D002772:Cholera Toxin / Q000276:immunology* / Q000378:metabolism; D003967:Diarrhea / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004768:Enterotoxins / Q000378:metabolism; D004926:Escherichia coli / Q000276:immunology; D004927:Escherichia coli Infections / Q000382:microbiology / Q000517:prevention & control*; D029968:Escherichia coli Proteins / Q000276:immunology* / Q000378:metabolism; D022361:Escherichia coli Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D036781:Fimbriae Proteins / Q000276:immunology* / Q000378:metabolism; D006166:Guatemala; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D014195:Travel; D016896:Treatment Outcome; D015164:Vaccines, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D001427:Bacterial Toxins; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D022361:Escherichia coli Vaccines; D015164:Vaccines, Inactivated; C022924:colonization factor antigens; D036781:Fimbriae Proteins; D002772:Cholera Toxin; C027538:heat-labile enterotoxin, E coli