Status:
COMPLETED
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
Emergent BioSolutions
Conditions:
Cholera
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01895855
Start Date
September 1 2013
End Date
November 1 2014
Last Update
June 28 2023
Active Locations (3)
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1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
2
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
University of Vermont
Burlington, Vermont, United States, 05405