Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3

PHASE1CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

January 7, 2013

Primary Completion Date

May 12, 2015

Study Completion Date

May 12, 2015

Conditions
Shigella Infection
Interventions
OTHER

Placebo

Placebo comparator: 1 or 1.5 ml of sterile normal saline 0.9% added to 30 mL of 0.9% sterile normal saline, given orally.

BIOLOGICAL

WRSs2

WRSs2 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10\^3 colony-forming units (cfu) to 1x10\^7 cfu.

BIOLOGICAL

WRSs3

WRSs3 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10\^3 colony-forming units (cfu) to 1x10\^7 cfu.

Trial Locations (1)

45229-3039

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01336699 - Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3 | Biotech Hunter | Biotech Hunter