A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Avant Immunotherapeutics1 site in 1 country180 target enrollmentJuly 2007

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

June 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Avant Immunotherapeutics

•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

•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