Status:
WITHDRAWN
Phase 1 meCS6 + LT(R192G) Vaccine Study
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Diarrhea
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-...
Detailed Description
The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects (minimum of 52 allowable) will receive on of two oral vaccine doses according to the following char...
Eligibility Criteria
Inclusion
- Available for required follow-up period
- Women must have a negative pregnancy test
- Women must not to try to become pregnant while on study and for 2 months after study is completed
Exclusion
- History of travellers' diarrhea
- Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine
- Regular use of anti-diarrheal, anti-constipation, or antacid therapy
- Abnormal bowel habits
- Pregnant or nursing women
- History of chronic gastrointestinal illness or major gastrointestinal surgery
- Allergies to vaccines
- Positive HIV, Hepatitis B or Hepatitis C tests
- Regular use of oral steroid medication
- Clinically significant abnormalities on physical examination
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00090688
Start Date
August 1 2004
Last Update
December 28 2016
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20895