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NCT03548064 · ClinicalTrials.gov registry record · Phase 1
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT03548064 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 75 participants.
The verdict
NCT03548064, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study duration is approximately 2.5 years, with each participant duration for up to 9 months depending on the route of dmLT administered. There is no specific hypothesis being tested in this study. The primary objective of this study is to assess the reactogenicity, safety, and tolerability of dmLT when administered in three sequential doses, over a range of dosages by oral, sublingual, or intradermal routes.
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 | 75 participants |
| Start Date | 2019-03-10 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03548064
The ClinicalTrials.gov registry entry for NCT03548064 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03548064 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03548064 about?
NCT03548064 is a clinical study titled "A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area". This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study duration is approximate...
What is the current status of trial NCT03548064?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2019-03-10. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03548064?
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 NCT03548064?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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