Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
This study has been completed.
Sponsor:
Avant Immunotherapeutics
Information provided by:
Avant Immunotherapeutics
ClinicalTrials.gov Identifier:
NCT00498654
First received: July 9, 2007
Last updated: June 27, 2008
Last verified: June 2008
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Purpose
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Typhoid Fever |
Biological: Ty800 (Salmonella typhi) Oral Vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Avant Immunotherapeutics:
Primary Outcome Measures:
- Immunogenicity [ Time Frame: Baseline through Day 14 ] [ Designated as safety issue: No ]
- Reactogenicity [ Time Frame: Baseline through Month 1 follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Longterm safety and immunogenicity [ Time Frame: Month 1 to 6 post-dosing ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498654
Locations
| 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 | |
Sponsors and Collaborators
Avant Immunotherapeutics
Investigators
| Principal Investigator: | Clark McKeever, MD | Accelovance LLC |
More Information
No publications provided
| Responsible Party: | AVANT Immnunotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00498654 History of Changes |
| Other Study ID Numbers: | Ty800-07-0001 |
| Study First Received: | July 9, 2007 |
| Last Updated: | June 27, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on June 18, 2013