OBJECTIVE: To review trials evaluating the efficacy and safety of Vaxchora, a 
reformulated, single-dose, oral, lyophilized Vibrio cholerae CVD 103-HgR vaccine 
for the prevention of travel-related cholera caused by V cholerae serogroup O1.
DATA SOURCES: A literature search was conducted using MEDLINE (1946 to January 
week 3, 2017) and EMBASE (1996 to 2017 week 3). Keywords included oral cholera 
vaccine, single-dose, Vaxchora, and CVD 103-HgR. Limits included human, clinical 
trials published in English since 2010. ClinicalTrials.gov was used as a source 
for unpublished data. Additional data sources were obtained through 
bibliographic review of selected articles.
STUDY SELECTION AND DATA EXTRACTION: Studies that addressed the safety and 
efficacy of Vaxchora, the reformulated, single-dose oral CVD 103-HgR cholera 
vaccine, were selected for analysis.
DATA SYNTHESIS: Approval of Vaxchora, was based on efficacy of the vaccine in 
human trials demonstrating 90.3% protection among those challenged with V 
cholerae 10 days after vaccination and in immunogenicity studies with 90% 
systemic vibriocidal antibody conversion at 6 months after a single-dose of 
vaccine. Tolerability was acceptable, with the most common adverse effects 
reported to be fatigue, headache, and abdominal pain.
CONCLUSION: Vaxchora is the only FDA-approved, single-dose oral vaccine for the 
prevention of cholera caused by V cholerae serogroup O1 in adult travelers from 
the United States going to cholera-affected areas. Safety and efficacy has not 
been established in children, immunocompromised persons, and pregnant or 
breastfeeding women or those living in cholera-endemic areas.