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

NCT02556996 | Completed Phase 3 DMC

• 1 other identifier: HSRRB A-7965
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen.

  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.

  365-day period starting 14 days after the third vaccination

Secondary Outcomes (5)

• 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

• All events of diarrhea irrespective of etiology

  365-day period starting 14 days after the third vaccination

• IgG seroconversion

  Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose

• IgA seroconversion

  Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose

• Number of solicited adverse events

  3-day period after each dose

Study Arms (2)

Killed ETEC/rCTB vaccine

EXPERIMENTAL

Three doses administered orally at 2-week intervals

Biological: ETEC/rCTB vaccine

Placebo

PLACEBO COMPARATOR

Three doses administered orally at 2-week intervals

Other: Placebo

Interventions

ETEC/rCTB vaccine 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)

Killed ETEC/rCTB vaccine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Global developmental delay
• Severe malnutrition
• Chronic bedridden status
• Serious chronic disorder requiring chronic medication

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• U.S. Naval Medical Research Unit No. 3: collaborator
• Ministry of Health and Population, Egypt: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• International Vaccine Institute: collaborator
• Göteborg University: collaborator

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Savarino, MD, MPH

  Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 1998
• Primary Completion: March 1, 2001
• Study Completion: April 1, 2002
• Last Updated: October 12, 2015

Record last verified: 2015-10