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Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate

Diarrhea Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

This study is designed as 2 parts.

- Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14 vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo given with bicarbonate buffer.

- Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10 vaccinees from the first part and 10 naïve controls. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01080716
Study type Interventional
Source U.S. Army Medical Research and Materiel Command
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2010
Completion date December 2011
View Details
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