At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Dose Escalating Study of Two Enterotoxigenic Escherichia Coli Prototype Adhesin-based Vaccines With or Without Modified Heat-labile Enterotoxin by Intradermal or Transcutaneous Immunization
U.S. Army Medical Research and Development Command·interventional·Posted Jul 19, 2012·Updated Feb 12, 2021
In Brief
A Phase 1 clinical trial evaluating Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE, and 1 other intervention for Escherichia Coli Infection. Completed, enrolled 57 participants across 1 site.
Detailed Summary
The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEscherichia Coli Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartAug 2012
Primary CompletionJun 2014
Study CompletionJun 2015
TodayJul 2026
First PostedJul 19, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago
Interventions
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5biological
Recombinant fimbrial adhesin dscCfaEbiological
Modified E. coli heat labile enterotoxin LTR192Gbiological