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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years

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 or infection;
• 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.