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

Avant Immunotherapeutics

Status and phase

Completed

Phase 2

Conditions

Typhoid Fever

Treatments

Biological: Ty800 (Salmonella typhi) Oral Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

Ty800-07-0001

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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