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

Bavarian Nordic

Status and phase

Completed

Phase 3

Conditions

Cholera

Treatments

Biological: placebo

Biological: PXVX0200

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895855

PXVX-VC-200-003

Details and patient eligibility

About

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

Full description

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

Enrollment

197 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.