Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Typhoid
Interventions
BIOLOGICAL

Dose of 5.0 x 10^9 CFU (Cohort 1)

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

BIOLOGICAL

Dose of 7.5 x 10^9 CFU (Cohort 2)

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

BIOLOGICAL

Dose of 1.1 x 10^10 CFU (Cohort 3)

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

BIOLOGICAL

Dose of of 1.7 x 10^10 CFU (Cohort 4)

S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration

OTHER

Placebo (Cohorts 1-4 pooled)

Excipients only, single dose, oral administration

Trial Locations (3)

21205

John Hopkins Bloomberg School of Public Health, Baltimore

33143

Miami Research Associates, South Miami

05405

Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington

Sponsors
All Listed Sponsors
lead

Emergent BioSolutions

INDUSTRY