CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
Shigella flexneri 2a InvaplexARbiological
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/NCT02445963
NCT02445963Phase 1Completed
CompareCT.gov

A Phase 1 Open-label, Dose Escalating Study of Artificial Shigella Flexneri 2a InvaplexAR Administered Intranasally to Healthy, Adult Volunteers to Evaluate Safety and Immunogenicity

U.S. Army Medical Research and Development Command·interventional·Posted May 15, 2015·Updated Feb 12, 2021

In Brief

A Phase 1 clinical trial evaluating Shigella flexneri 2a InvaplexAR for Shigellosis and Bacillary Dysentery. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShigellosis, Bacillary Dysentery
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 15, 2015
Enrollment StartOct 1, 2015
Primary CompletionMay 13, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.1 years ago

Interventions

Shigella flexneri 2a InvaplexARbiological

The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.