Brief Title
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Official Title
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
Brief Summary
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine
in healthy adult subjects.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Immunogenicity
Secondary Outcome
Longterm safety and immunogenicity
Condition
Typhoid Fever
Intervention
Ty800 (Salmonella typhi) Oral Vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
180
Start Date
July 2007
Completion Date
June 2008
Primary Completion Date
October 2007
Eligibility Criteria
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
Gender
All
Ages
18 Years - 55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clark McKeever, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00498654
Organization ID
Ty800-07-0001
Study Sponsor
Avant Immunotherapeutics
Study Sponsor
Clark McKeever, MD, Principal Investigator, Accelovance LLC
Verification Date
June 2008