CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
CssBA +1 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.

Search/NCT03404674
NCT03404674Phase 1Completed
CompareCT.gov

A Phase 1 Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)

PATH·interventional·Posted Jan 19, 2018·Updated Jan 6, 2021

In Brief

A Phase 1 clinical trial evaluating CssBA and dmLT for Diarrhea. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesUnited States
CollaboratorsNaval Medical Research Center, Walter Reed Army Institute of Research (WRAIR)

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 19, 2018
Enrollment StartJan 16, 2018
Primary CompletionMar 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.5 years ago

Interventions

CssBAbiological

Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B

dmLTbiological

Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211