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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Biological: ETEC/rCTB vaccine; Other: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02556996

HSRRB A-7965

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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356 participants in 2 patient groups, including a placebo group

Killed ETEC/rCTB vaccine

Experimental group

Description:

Three doses administered orally at 2-week intervals

Treatment:

Biological: ETEC/rCTB vaccine

Placebo

Placebo Comparator group

Description:

Three doses administered orally at 2-week intervals

Treatment:

Other: Placebo