Phase 1 meCS6 + LT(R192G) Vaccine Study
Withdrawn before enrolling · Phase 1
Conditions studied: Diarrhea
In brief
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-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up. Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned. Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.
Key facts
- Study ID
- NCT00090688
- Run by
- U.S. Army Medical Research and Development Command
- People needed
- 0
- Starts
- 2004-08-01
- Last updated by the study team
- 2016-12-28
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Walter Reed Army Institute of Research — Silver Spring, Maryland, United States
Full record on ClinicalTrials.gov
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