Status:
WITHDRAWN
Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Diarrhea
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.
Detailed Description
This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart: Group / N\* / rFla-MBP A / ...
Eligibility Criteria
Inclusion
- Healthy adult
- 70% accuracy on comprehension test
- Availability for required visits and telephone follow up
Exclusion
- Pregnancy or breastfeeding
- Chronic health problems
- Abnormalities found on physical examination
- Use of immunosuppressive drugs, such as corticosteroids or chemotherapy
- Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV)
- Abnormalities found on basic laboratory screening
- Prior exposure to Campylobacter
- Current smoker
- Chronic sinusitis or seasonal rhinitis
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00124865
Start Date
July 1 2005
End Date
November 1 2006
Last Update
September 26 2017
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910