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NCT02531685 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT02531685: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02531685 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531685, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal (ID) route. The sample size has been determined based on the historic sample, not on power calculations.The study will involve 99 subjects (83 vaccinees and 16 placebo controls) in 4 consecutive cohorts of 16 individuals each (13 vaccinees and 3 placebo controls) and the final cohort of 35 (31 vaccinees and 4 placebos) subjects. The primary objective is to assess the safety and tolerability of dmLT vaccine when administered in three doses intradermally over a range of dosages in healthy adult subjects.
Interventions
- OTHER Placebo
- BIOLOGICAL Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-06-02 |
| Est. Completion | 2020-05-04 |
| Phase | Phase 1 |
What the finished NCT02531685 record still lists
NCT02531685 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02531685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531685 about?
NCT02531685 is a clinical study titled "Phase 1 Study of dmLT ID Vaccination in Healthy Adults". This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal (ID) route. The sample size has been determined based on the historic sam...
What is the current status of trial NCT02531685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2016-06-02. Estimated completion is 2020-05-04.
What interventions are being tested in trial NCT02531685?
The interventions under investigation include: Placebo (OTHER), Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02531685?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02531685's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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