Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Primary Purpose
Typhoid Fever
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ty800 (Salmonella typhi) Oral Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Typhoid Fever focused on measuring Prevention of Typhoid Fever in Adult Travelers
Eligibility 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
Sites / Locations
- Accelovance LLC
- Accelovance LLC
- Accelovance LLC
- Accelovance LLC
- Accelovance LLC
Outcomes
Primary Outcome Measures
Immunogenicity
Reactogenicity
Secondary Outcome Measures
Longterm safety and immunogenicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00498654
Brief Title
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Avant Immunotherapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Fever
Keywords
Prevention of Typhoid Fever in Adult Travelers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Ty800 (Salmonella typhi) Oral Vaccine
Primary Outcome Measure Information:
Title
Immunogenicity
Time Frame
Baseline through Day 14
Title
Reactogenicity
Time Frame
Baseline through Month 1 follow-up
Secondary Outcome Measure Information:
Title
Longterm safety and immunogenicity
Time Frame
Month 1 to 6 post-dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark McKeever, MD
Organizational Affiliation
Accelovance LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Accelovance LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Accelovance LLC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Accelovance LLC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Accelovance LLC
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Accelovance LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
We'll reach out to this number within 24 hrs