At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
VLA1701 +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.
Randomized Double-Blinded Pilot Study Confirming A Human Challenge Model Using LSN03-016011/A Expressing LT And CS17 And Investigating The Safety Of VLA1701 (An Investigational Oral Cholera And ETEC (Enterotoxigenic E Coli) (Vaccine)
In Brief
A Phase 2 clinical trial evaluating VLA1701, Placebo, and 1 other intervention for Enterotoxigenic Escherichia Coli Infection and Diarrhea. Completed, enrolled 34 participants across 1 site.
Detailed Summary
This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsJohns Hopkins University, Naval Medical Research Center
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
Primary CompletionJun 2018
First PostedJul 2018
Study CompletionNov 2018
TodayJul 2026
First PostedJul 3, 2018
Enrollment StartJun 4, 2018
Primary CompletionJun 26, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 22 daysPosted 8.0 years ago
Interventions
VLA1701biological
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
Placebobiological
buffer component of VLA1701
Challenge Strainother
LSN03-016011/A