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NCT01739231 · ClinicalTrials.gov registry record · Phase 1
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT01739231 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 81 participants.
The verdict
NCT01739231, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children living in developing countries and in travelers to those countries. This research study is also testing an investigational adjuvant called dmLT. An adjuvant is something that is added to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe, tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine by itself or the vaccine combined with the adjuvant prevents diarrheal disease when challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A, and they will be required to stay in the research facility for several nights for the first dose, but will not be required to stay overnight for the second and third doses. Participants will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo by mouth. Study procedures include: stool samples, blood samples, and documentation of side effects. Participants will be involved in study related procedures for about 8 months. Interested volunteers from Part A will along with volunteers who were never vaccinated in Part A will return to participate in Part B. These volunteers will be required to stay overnight in the research facility for several nights after challenge, after which they will be treated with antibiotics and sent home. Study procedures include stool samples, blood samples, and documentation of infection with ETEC H10407. If the vaccine with/without adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.
Interventions
- BIOLOGICAL dmLT
- BIOLOGICAL ACE527
- BIOLOGICAL CeraVacx placebo
- BIOLOGICAL H10407 challenge strain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01739231
The ClinicalTrials.gov registry entry for NCT01739231 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PATH, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which dmLT is the first listed.
NCT01739231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01739231 about?
NCT01739231 is a clinical study titled "Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults". This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children living in developing countries and in...
What is the current status of trial NCT01739231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2012-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01739231?
The interventions under investigation include: dmLT (BIOLOGICAL), ACE527 (BIOLOGICAL), CeraVacx placebo (BIOLOGICAL), H10407 challenge strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT01739231?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
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