Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent C… (NCT01895855) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
United States197 participantsStarted 2013-09
Plain-language summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Who can participate
Age range18 Years – 45 Years
SexALL
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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.
What they're measuring
1
% of Participants With Moderate to Severe Diarrhea
Timeframe: Ten days after vaccination
2
% of Participants With Moderate to Severe Diarrhea