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:
Information provided by:
Avant Immunotherapeutics
ClinicalTrials.gov Identifier:
NCT00498654
First received: July 9, 2007
Last updated: June 27, 2008
Last verified: June 2008
  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
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, see Learn About Clinical Studies.

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 July 31, 2014