AzTrials
AzTrials

DiarrheaPhase 3NCT02556996

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

A Phase 3 study testing ETEC/rCTB vaccine in people with Diarrhea, run by U.S. Army Medical Research and Development Command.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Diarrhea
What is being tested?
ETEC/rCTB vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
356 participants
Where
No sites listed yet
Study dates
Oct 1998to Apr 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

About this study

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
Being tested
ETEC/rCTB vaccine, Placebo
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETEC/rCTB vaccineBiological

    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)

  • PlaceboOther

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

Study groups in NCT02556996
Study groupRoleWhat they receive
Killed ETEC/rCTB vaccineExperimentalThree doses administered orally at 2-week intervals
Receives: Biological: ETEC/rCTB vaccine
PlaceboPlacebo comparatorThree doses administered orally at 2-week intervals
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 365-day period starting 14 days after the third vaccination

Secondary outcomes (5)

  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 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.

    Measured: 365-day period starting 14 days after the third vaccination

  2. All events of diarrhea irrespective of etiology

    All events (i.e., initial plus recurrent) of diarrhea associated with excretion of any ETEC, irrespective of phenotype, and no other copathogen.

    Measured: 365-day period starting 14 days after the third vaccination

  3. IgG seroconversion

    IgG seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and vaccine-specific colonization factors CFA/I, CS2, CS4

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

  4. IgA seroconversion

    IgA seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and selected vaccine-specific colonization factors CFA/I, CS2, CS4

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

  5. Number of solicited adverse events

    (i.e., diarrhea, vomiting, fever by caregiver report, poor feeding, and irritability)

    Measured: 3-day period after each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study startOct 1998
  3. Primary completionMar 2001
  4. Study completionApr 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02556996
Sponsor's protocol ID
HSRRB A-7965
Status last verified
Oct 2015
First submitted
21 Sep 2015
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ETEC/rCTB vaccine in people with Diarrhea, run by U.S. Army Medical Research and Development Command.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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