Indications for: VAXCHORA
Immunization against disease caused by Vibrio cholerae serogroup 01 in individuals 2–64 years of age traveling to cholera-affected areas.
Limitations of Use:
Efficacy not established in persons living in cholera-affected areas or persons with pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Not shown to protect against disease caused by V. cholerae serogroup 0139 or other non-01 serogroups.
Efficacy Against V. cholerae Challenge
The efficacy of Vaxchora was evaluated in a randomized, double-blind, placebo-controlled human challenge study (n=197) of US volunteers aged 18–45 years old. Of the total volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae. The efficacy of Vaxchora was 90.3% (95% CI, 62.7-100) among those challenged 10 days post-vaccination, and 79.5% (95% CI, 49.9-100) among those challenged 3 months post-vaccination.
Vibriocidal Antibody Against the Vaccine Strain (classical Inaba)
A vibriocidal antibody assay was used to measure serum levels of neutralizing antibodies against the vaccine strain.
In the subset of subjects challenged in Study 2, 91% [95% CI, 82%-97%] of vaccinees seroconverted prior to challenge and 9% developed moderate to severe cholera following challenge, while 2% of placebo recipients seroconverted prior to challenge and 59% developed moderate to severe cholera following challenge.
Vaxchora was evaluated in the randomized, double-blind, placebo-controlled safety and immunogenicity study conducted in the US and Australia. A total of 3146 patients 18 to 45 years of age who were not previously exposed to cholera were randomly assigned 8:1 to receive one dose of Vaxchora or placebo. The classical Inaba vibriocidal antibody seroconversion rates were 93.5% (95% CI, 92.5%-94.4%] in vaccine recipients and 4% (95% CI, 2%-7%) in placebo recipients at 10 days post-vaccination.
The safety and immunogenicity of Vaxchora was evaluated in a randomized, double-blind, placebo-controlled study conducted in the US. A total of 398 patients 46 to 64 years of age with no prior history of cholera infection or travel to a cholera-endemic era in the previous 5 years were randomly assigned 3:1 to receive one dose of Vaxchora or placebo. The classical Inaba vibriocidal antibody seroconversion rates were 90.4% (95% CI, 86.4%-93.5%] in vaccine recipients at 10 days post-vaccination.
Vibriocidal Antibody Against Classical Ogawa, El Tor Inaba and El Tor Ogawa
V. cholerae serogroup O1 consists of four major subtypes: classical Inaba, classical Ogawa, El Tor Inaba and El Tor Ogawa. Serum vibriocidal antibody against the three types of V. cholerae not contained in the vaccine, namely classical Ogawa, El Tor Inaba and El Tor Ogawa, was also measured in Study 2 and Study 4. The percentages of vaccine recipients who seroconverted against each of the 4 major biotype/serotypes of V. cholerae serogroup O1 at 10 days postvaccination (71.4% to 91.4%).
Pediatric Trial - Vibriocidal Antibody Against the Vaccine Strain (classical Inaba)
The safety and immunogenicity of Vaxchora was evaluated in a randomized, double-blind, placebo-controlled study conducted in the US, which included a total of 550 patients 2 through 17 years of age who were not previously exposed to cholera. Patients were randomly assigned 6:1 to receive one dose of Vaxchora or placebo. Randomization was stratified by age into 3 age cohorts: 12 to less than 18 years of age (Cohort 1); 6 to less than 12 years of age (Cohort 2); and 2 to less than 6 years of age (Cohort 3).
The classical Inaba vibriocidal antibody seroconversion rates were 98.5% (95% CI, 96.2%-99.4%] in vaccine recipients at 10 days post-vaccination.
Adults and Children:
<2yrs: not established. For oral administration only. Avoid food or drink for 60mins before and after administration. Give single oral dose of 100mL (for individuals 6–64yrs) or 50mL (for children 2–<6yrs) a minimum of 10 days before potential cholera exposure. Safety and efficacy of revaccination with Vaxchora: not established.
Severe allergic reaction to any previous cholera vaccine.
Immunocompromised, elderly (≥65yrs). Considering whether to administer to individuals with immunocompromised close contacts. Pregnancy.
Avoid use within 14 days of systemic antibiotics. Give vaccine ≥10 days prior to antimalarial prophylaxis with chloroquine. Concomitant immunosuppressive therapy (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose corticosteroids): may get suboptimal response.
Tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, diarrhea.
To enroll patients in the pregnancy exposure registry call (800) 533-5899.
Generic Drug Availability:
Single-dose carton—2 packets (buffer component + active component)