Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200 (NCT01585181) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
United States66 participantsStarted 2012-04
Plain-language summary
The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
* Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
* Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
* Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)
Exclusion Criteria:
* Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
* Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
* Resides with HHCs who are under the age of 18 or over the age of 65
* Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
* Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
* Previously received a licensed or investigational cholera vaccine
* Has history of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge)
* Travel to a cholera-endemic area and experienced symptoms consistent …