NCT01080716

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Dysentery
• Shigella
• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Part 1/Arm 1 of Study: WRSS1 vaccine	Single, oral dose of WRSS1
BIOLOGICAL	Part 1/Arm 2 of Study: Placebo vaccine	Placebo vaccine
BIOLOGICAL	Part 2/Arm 1 of Study: S. sonnei 53G	Subject from Part 1/Arm 1 of Study are given 53G S. sonnei
BIOLOGICAL	Part 2/Arm 2 of Study: S. sonnei 53G	10 naïve controls are given S. sonnei 53G

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• Completion: 2011-12-01
• First posted: 2010-03-04
• Last updated: 2018-11-13
• Results posted: 2018-11-13

Locations

1 site across 1 country: Thailand