NCT Number: NCT00498654
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Accelovance LLC, San Diego, California, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Immunogenicity
Time frame: Baseline through Day 14
-
Reactogenicity
Time frame: Baseline through Month 1 follow-up
Secondary outcomes
-
Longterm safety and immunogenicity
Time frame: Month 1 to 6 post-dosing
Sponsors and collaborators
Lead sponsor
Avant Immunotherapeutics
Industry
Registry information
Official study 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
Important dates
- Study start
- 2007
- Primary completion
- 2007
- Study completion
- 2008
- First posted
- Jul 10, 2007
- Registry last updated
- Jul 2, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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