Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT00498654 |
Recruitment Status
:
Completed
First Posted
: July 10, 2007
Last Update Posted
: July 2, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Typhoid Fever | Biological: Ty800 (Salmonella typhi) Oral Vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | June 2008 |

- Immunogenicity [ Time Frame: Baseline through Day 14 ]
- Reactogenicity [ Time Frame: Baseline through Month 1 follow-up ]
- Longterm safety and immunogenicity [ Time Frame: Month 1 to 6 post-dosing ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498654
United States, California | |
Accelovance LLC | |
San Diego, California, United States, 92108 | |
United States, Florida | |
Accelovance LLC | |
Melbourne, Florida, United States, 32935 | |
United States, Illinois | |
Accelovance LLC | |
Peoria, Illinois, United States, 61602 | |
United States, Indiana | |
Accelovance LLC | |
South Bend, Indiana, United States, 46601 | |
United States, Texas | |
Accelovance LLC | |
Houston, Texas, United States, 77024 |
Principal Investigator: | Clark McKeever, MD | Accelovance LLC |
Responsible Party: | AVANT Immnunotherapeutics |
ClinicalTrials.gov Identifier: | NCT00498654 History of Changes |
Other Study ID Numbers: |
Ty800-07-0001 |
First Posted: | July 10, 2007 Key Record Dates |
Last Update Posted: | July 2, 2008 |
Last Verified: | June 2008 |
Keywords provided by Avant Immunotherapeutics:
Prevention of Typhoid Fever in Adult Travelers |
Additional relevant MeSH terms:
Fever Typhoid Fever Body Temperature Changes Signs and Symptoms Salmonella Infections Enterobacteriaceae Infections |
Gram-Negative Bacterial Infections Bacterial Infections Vaccines Immunologic Factors Physiological Effects of Drugs |