Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

2002-04-30

Brief Summary

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This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over a one year period of follow-up by active surveillance. The vaccine consists of a mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is heat-killed Escherichia coli K-12 bacteria.

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Detailed Description

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Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Killed ETEC/rCTB vaccine

Three doses administered orally at 2-week intervals

Group Type EXPERIMENTAL

ETEC/rCTB vaccine

Intervention Type BIOLOGICAL

Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10\^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg)

Placebo

Three doses administered orally at 2-week intervals

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10\^11 heat-killed bacteria per dose)

Interventions

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ETEC/rCTB vaccine

Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10\^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg)

Intervention Type BIOLOGICAL