At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
Invaplex[AR-DETOX] +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.
A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine
In Brief
A Phase 1 clinical trial evaluating Invaplex[AR-DETOX] and Placebo for Diarrhea. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\[AR-Detox\]) vaccine candidate administered by intramuscular immunization.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedMar 11, 2019
Enrollment StartMar 18, 2019
Primary CompletionJun 12, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.3 years ago
Interventions
Invaplex[AR-DETOX]biological
Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex\[AR-Detox\]) Vaccine
Placeboother
Saline