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Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

This study has been completed.

Sponsored by: Avant Immunotherapeutics
Information provided by: Avant Immunotherapeutics
ClinicalTrials.gov Identifier: NCT00498654
  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 II

MedlinePlus related topics:   Fever   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

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

Responsible Party:   AVANT Immnunotherapeutics
Study ID Numbers:   Ty800-07-0001
First Received:   July 9, 2007
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00498654
Health Authority:   United States: Food and Drug Administration

Keywords provided by Avant Immunotherapeutics:
Prevention of Typhoid Fever in Adult Travelers  

Study placed in the following topic categories:
Bacterial Infections
Fever
Signs and Symptoms
Enterobacteriaceae Infections
Salmonella Infections
Typhoid
Healthy
Typhoid fever
Typhoid Fever
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Body Temperature Changes

ClinicalTrials.gov processed this record on September 05, 2008




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