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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
Sponsor:
Information provided by:
Avant Immunotherapeutics

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

Condition or disease Intervention/treatment Phase
Typhoid Fever Biological: Ty800 (Salmonella typhi) Oral Vaccine Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: Baseline through Day 14 ]
  2. Reactogenicity [ Time Frame: Baseline through Month 1 follow-up ]

Secondary Outcome Measures :
  1. Longterm safety and immunogenicity [ Time Frame: Month 1 to 6 post-dosing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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