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NCT02052934 · ClinicalTrials.gov registry record · Phase 1
Safety of Sublingual dmLT for ETEC
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02052934 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants.
The verdict
NCT02052934, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives assess the safety and tolerability of dmLT vaccine when administered in three doses sublingually over a range of dosages in healthy adult subjects. The secondary objectives assess long-term safety follow-up from immunization through Month 7 post vaccination, following three SL doses of dmLT vaccine over a range of dosages and comparing with three doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy adult male and female subjects, ages 18 to 45. Subject participation duration is approximately 8 months with study duration of approximately 1.5-2 years, including 6-7 months of follow-up.
Interventions
- BIOLOGICAL Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-03-10 |
| Est. Completion | 2016-11-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052934
The ClinicalTrials.gov registry entry for NCT02052934 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 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 1 intervention - of which Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine is the first listed.
NCT02052934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02052934 about?
NCT02052934 is a clinical study titled "Safety of Sublingual dmLT for ETEC". A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives assess the safety and tolerability of dmL...
What is the current status of trial NCT02052934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2014-03-10. Estimated completion is 2016-11-02.
What interventions are being tested in trial NCT02052934?
The interventions under investigation include: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02052934?
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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