Trials / Completed
CompletedNCT01922856
Challenge Study of an ETEC Vaccine
A Phase 2b Controlled Efficacy Study of Intradermally Delivered ETEC Fimbrial Tip Adhesin Vaccine Against Experimental Challenge With ETEC H10407 in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- U.S. Army Medical Research and Development Command · Federal
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
Detailed description
The purpose of the study is to establish preliminary efficacy of dscCfaE administered with LTR192G by intradermal (ID) immunization in prevention of disease caused by a challenge with a CFA/I expressing ETEC strain (H10407).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LTR192G with dscCfaE | Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G) |
| OTHER | No Intervention | Controls only receive challenge |
Timeline
- Start date
- 2013-09-19
- Primary completion
- 2016-02-06
- Completion
- 2016-07-14
- First posted
- 2013-08-14
- Last updated
- 2017-07-06
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01922856. Inclusion in this directory is not an endorsement.