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.

Condition	Treatment or Intervention	Phase
Diarrhea	Vaccine: meCS6 + LT(R192G)	Phase I

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Maryland
      Walter Reed Army Institute of Research, Silver Spring,  Maryland,  20895,  United States; Recruiting

Study ID Numbers:  1065
Record last reviewed:  September 2004
Record first received:  September 2, 2004
ClinicalTrials.gov Identifier:  NCT00090688
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09