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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556996
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 12, 2015
Sponsor:
Collaborators:
U.S. Naval Medical Research Unit No. 3
Ministry of Health and Population, Egypt
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Vaccine Institute
Göteborg University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diarrhea Biological: ETEC/rCTB vaccine Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
Study Start Date : October 1998
Actual Primary Completion Date : March 2001
Actual Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Killed ETEC/rCTB vaccine
Three doses administered orally at 2-week intervals
Biological: 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)

Placebo Comparator: Placebo
Three doses administered orally at 2-week intervals
Other: Placebo
Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10^11 heat-killed bacteria per dose)




Primary Outcome Measures :
  1. Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen. [ Time Frame: 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 :
  1. 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.. [ Time Frame: 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.

  2. All events of diarrhea irrespective of etiology [ Time Frame: 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.

  3. IgG seroconversion [ Time Frame: 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

  4. IgA seroconversion [ Time Frame: 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

  5. Number of solicited adverse events [ Time Frame: 3-day period after each dose ]
    (i.e., diarrhea, vomiting, fever by caregiver report, poor feeding, and irritability)



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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556996


Sponsors and Collaborators
U.S. Army Medical Research and Development Command
U.S. Naval Medical Research Unit No. 3
Ministry of Health and Population, Egypt
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Vaccine Institute
Göteborg University
Investigators
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Principal Investigator: Stephen Savarino, MD, MPH Naval Medical Research Center

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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02556996    
Other Study ID Numbers: HSRRB A-7965
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vaccines
Immunologic Factors
Physiological Effects of Drugs