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

Phase 3

Completed

• Conditions: Diarrhea

• Registration Number: NCT02556996
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2001-03
• Study Completion: 2002-04
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

1. Willingness of parent to have the child participate;
2. Plans to reside in catchment area continuously for at least one year

Exclusion Criteria

1. Global developmental delay
2. Severe malnutrition
3. Chronic bedridden status
4. Serious chronic disorder requiring chronic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen.	365-day period starting 14 days after the third vaccination	Time to first event of diarrhea associated with excretion of VP-ETEC (defined as ETEC expressing heat-labile \[LT\] and heat-stable enterotoxin \[ST\], or ST and a vaccine-shared colonization factor \[i.e., CFA/I, CS1, CS2, CS3, CS4, and/or CS5\]) and no other copathogen.

Secondary Outcome Measures

Name	Time	Method
Time to first event of diarrhea due to ST-only ETEC expressing a vaccine-shared CF (ST-VCF-ETEC) as defined below, and no other copathogen..	365-day period starting 14 days after the third vaccination	Time to first event of diarrhea associated with excretion of ST-VCF-ETEC (defined as ETEC expressing ST-only plus any vaccine-shared colonization factor \[i.e., CFA/I, CS1, CS2, CS3, CS4, and/or CS5\]) and no other copathogen.
All events of diarrhea irrespective of etiology	365-day period starting 14 days after the third vaccination	All events (i.e., initial plus recurrent) of diarrhea associated with excretion of any ETEC, irrespective of phenotype, and no other copathogen.
IgG seroconversion	Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose	IgG seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and vaccine-specific colonization factors CFA/I, CS2, CS4
IgA seroconversion	Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose	IgA seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and selected vaccine-specific colonization factors CFA/I, CS2, CS4
Number of solicited adverse events	3-day period after each dose	(i.e., diarrhea, vomiting, fever by caregiver report, poor feeding, and irritability)