NCT01531530

Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP

Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.

Detailed description

There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.

Conditions

• Shigella

Interventions

Type	Name	Description
BIOLOGICAL	CVD 1208S, a Shigella flexneri 2a live, oral vaccine	The vaccine is mixed with salt water and given by mouth.
OTHER	Placebo	Corn starch and baking soda are mixed with salt water and given by mouth.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-02-13
• Last updated: 2021-04-30

Locations

2 sites across 1 country: United States