At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 56 enrolled

Drug / intervention

Shigella sonnei 53Gbiological

Likely dose

Shigella sonnei 53Gfrom 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/NCT02816346

NCT02816346Phase 1Completed

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Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain

PATH·interventional·Posted Jun 28, 2016·Updated Jun 3, 2019

In Brief

A Phase 1 clinical trial evaluating Shigella sonnei 53G for Healthy. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesUnited States

CollaboratorsUnited States Department of Defense, Children's Hospital Medical Center, Cincinnati

Timeline

Phase 1CompletedFinished

2017201820192020202120222023202420252026

First PostedJun 2016

Enrollment StartSep 2016

Primary CompletionDec 2017

TodayJul 2026

First PostedJun 28, 2016

Enrollment StartSep 12, 2016

Primary CompletionDec 31, 2017

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

Shigella sonnei 53Gbiological

Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast. Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)