Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Phase 2

Completed

• Conditions: Typhoid Fever

• Registration Number: NCT00498654
• Lead Sponsor: Avant Immunotherapeutics

Brief Summary

The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Primary Completion: 2007-10
• Status Verified: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-27
• Last Update Posted: 2008-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Healthy Males or Females aged 18 to 55 years, inclusive
• Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion Criteria

• History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
• History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
• History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
• History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
• Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
• People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity	Baseline through Day 14
Reactogenicity	Baseline through Month 1 follow-up

Secondary Outcome Measures

Name	Time	Method
Longterm safety and immunogenicity	Month 1 to 6 post-dosing

Trial Locations

Locations (1)

Accelovance LLC; 🇺🇸 Houston, Texas, United States