Development of Pathogenicity-Driven Definitions of Outcomes for a Field Trial of a Killed Oral Vaccine against Enterotoxigenic Escherichia coli in Egypt Application of an Evidence-Based Method

To design an efficacy trial of a killed oral vaccine against enterotoxigenic Escherichia coli (ETEC) diarrhea in Egyptian children, we derived for ETEC diarrhea an empirical definition that increased the probability that diarrhea associated with excretion of ETEC was caused by the detected ETEC. We...

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Bibliographic Details
Published in:The Journal of infectious diseases 2004-06, Vol.189 (12), p.2299-2307
Main Authors: Clemens, John, Savarino, Stephen, Abu-Elyazeed, Remon, Safwat, Mohammad, Rao, Malla, Wierzba, Thomas, Svennerholm, Ann-Marie, Holmgren, Jan, Frenck, Robert, Park, Eunsik, Naficy, Abdollah
Format: Article
Language:English
Subjects:
Antigens
Bacteria
Bacterial Toxins - metabolism
Child, Preschool
Clinical Trials as Topic - methods
Colonies
Diarrhea
Diarrhea - microbiology
Diarrhea - prevention & control
Egypt
Enterotoxins - metabolism
Escherichia coli
Escherichia coli - isolation & purification
Escherichia coli - metabolism
Escherichia coli - pathogenicity
Escherichia coli Infections - microbiology
Escherichia coli Infections - prevention & control
Escherichia coli Proteins
Escherichia coli Vaccines - administration & dosage
Escherichia coli Vaccines - therapeutic use
Evidence-Based Medicine
Excretion
Experimentation
Feces - microbiology
Fimbriae Proteins - metabolism
Humans
Infant
Infections
Pathogens
Research Design
Toxins
Treatment Outcome
Vaccination
Vaccines, Inactivated - administration & dosage
Vaccines, Inactivated - therapeutic use
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Summary:To design an efficacy trial of a killed oral vaccine against enterotoxigenic Escherichia coli (ETEC) diarrhea in Egyptian children, we derived for ETEC diarrhea an empirical definition that increased the probability that diarrhea associated with excretion of ETEC was caused by the detected ETEC. We conducted a cohort study of 397 Egyptian children /=1 of the toxin- (heat-labile [LT] toxin) and colonization-factor antigens (CFA I, II, and IV) in the vaccine. Although fecal excretion of VP-ETEC was highly associated with diarrhea, excretion of LT-ETEC per se was not related to diarrhea (adjusted odds ratio [OR(A)], 1.16 [95% confidence interval [CI], 0.90-1.49]). The fecal excretion of antigenic types of VP-ETEC other than LT-ETEC (non-LT VP-ETEC) was highly associated with diarrheal symptoms (OR(A), 3.91 [95% CI, 2.78-5.49]; P
ISSN:0022-1899
1537-6613
DOI:10.1086/386288