NCT00679172

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

A Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study to Determine the Immunogenicity, Safety and Tolerability of S. Typhi (Ty2 aroC-ssaV-) ZH9 at Doses of 5.0 x 10E9 CFU, 7.5 x 10E9 CFU, 1.1 x 10E10 and 1.7 x 10E10 CFU and 1.7 x 10E10 CFU, Following Oral Administration to Healthy, Typhoid Vaccine naïve Subjects in the USA.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

Detailed description

This was a randomised, double-blind, placebo-controlled, single dose, dose escalation study with 4 dosing cohorts. Within each cohort, 45 evaluable subjects were planned (36 subjects receiving M01ZH09, 9 receiving placebo).

Conditions

• Typhoid

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-05-16
• Last updated: 2024-04-09
• Results posted: 2017-06-07

Locations

3 sites across 1 country: United States