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Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Cholera Clinical Trial

Official title:
A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain

Clinical Trial 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.

Clinical Trial Description

Approximately 60 subjects and up to 120 household contacts will be enrolled in the United States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01585181
Study type Interventional
Source Bavarian Nordic
Contact
Status Completed
Phase Phase 1
Start date April 2012
Completion date January 2013
View Details
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