Vaxchora is a live attenuated recombinant V. cholerae O1 Inaba Vaccine Strain CVD 103-HgR, which is able to synthesize the immunogenic nontoxic B subunit of CT (encoded by the ctxB gene).
The V. cholerae vaccine strain produces an incomplete, nontoxic version of the cholera toxin it then replicates in the gastrointestinal tract.
Vaxchora is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to an active cholera-affected area. Active transmission is defined as having cases reported within the past year.
The vaccine's benefits include the prevention of moderate to severe diarrhea caused by cholera bacteria in immunologically naive individuals.
Vaxchora is administered as a single oral dose at least 10 days before potential exposure to V. cholera.
Limitations of Use:
- The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.
- The effectiveness of Vaxchora has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine.
- Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.
Vaxchora Clinical Trials
Clinical Trial NCT03220737: VAXCHORA Pediatric Study
VAXCHORA is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.
VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goal of this Phase 4 study is to evaluate the safety and immunogenicity of VAXCHORA in children ages 2 years to <18 years of age in developed countries.
Clinical Trial NCT03251495: Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
The primary objective of this study is to evaluate the antibody response to the cholera vaccine, Vaxchora®, in healthy subjects.
Investigators also seek to evaluate additional markers of the adaptive immune response including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.