Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing
cholera infection

Inclusion Criteria:

- healthy men or women,

- age 18 to 45 years inclusive;

- normal medical history and physical examination; and

- no clinically significant abnormalities from:

- urine dipstick for glucose,

- protein, and

- blood,

- complete blood count,

- serum hepatic transaminases,

- total bilirubin (direct if abnormal),

- creatinine,

- electrolytes,

- albumin, or

- electrocardiogram.

- Women must have a negative pregnancy test.

Exclusion Criteria:

- travel to a cholera endemic area in the previous 5 years;

- abnormal stool pattern or regular use of laxatives;

- history of eating disorders (such as bulimia), anal or rectal disorders, allergy to
tetracycline and/or ciprofloxacin;

- history of cholera or enterotoxigenic E. coli challenge;

- current or recent antibiotic use;

- pregnancy or nursing;

- positive serology for HIV, hepatitis B antigen, or hepatitis C;

- any immunosuppressive medical condition;

- history of hospitalization for psychiatric illness or use of specific psychiatric
drugs.