CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Part 1/Arm 1 of Study: WRSS1 vaccine +3 morebiological
Likely dose
Part 2/Arm 1 of Study: S. 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/NCT01080716
NCT01080716Phase 2Completed
CompareCT.gov

Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella Sonnei Vaccine Candidate, in Healthy Thai Adults

U.S. Army Medical Research and Development Command·interventional·Posted Mar 4, 2010·Updated Nov 13, 2018

In Brief

A Phase 2 clinical trial evaluating Part 1/Arm 1 of Study: WRSS1 vaccine, Part 1/Arm 2 of Study: Placebo vaccine, and 2 other interventions for Dysentery and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysentery, Shigella, Diarrhea
CountriesThailand
CollaboratorsMahidol University, National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.3 years ago

Interventions

Part 1/Arm 1 of Study: WRSS1 vaccinebiological

Single, oral dose of WRSS1

Part 1/Arm 2 of Study: Placebo vaccinebiological

Placebo vaccine

Part 2/Arm 1 of Study: S. sonnei 53Gbiological

Subject from Part 1/Arm 1 of Study are given 53G S. sonnei

Part 2/Arm 2 of Study: S. sonnei 53Gbiological

10 naïve controls are given S. sonnei 53G