VAXCHORA

Vaxchora Generic Name & Formulations

Legal Class

General Description

Cholera vaccine, live attenuated (V. cholerae strain CVD 103-HgR); 100mL per single dose; susp for oral administration after reconstitution.

Pharmacological Class

Cholera vaccine.

How Supplied

Single-dose carton—2 packets (buffer component + active component)

Storage

Store Vaxchora buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C). Protect from light and moisture.
Packages may be stored at 48°F to 77°F (9°C to 25°C) for no more than 5 days prior to reconstitution.

Manufacturer

Bavarian Nordic, Inc.

Generic Availability

Mechanism of Action

Vaxchora contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against cholera following receipt of Vaxchora have not been determined.

Vaxchora Indications

Indications

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.

Vaxchora Dosage and Administration

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.

Other Modifications

Immunocompromised Individuals

Safety and efficacy have not been established in immunocompromised individuals. These individuals may get suboptimal immune responses.

Administration

Preparation, Reconstitution and Administration

Pour 100 mL of cold or room temperature (41ºF-72ºF; 5ºC-22ºC) bottled water (purified, spring, or sparkling [carbonated]) into a clean, disposable cup. Do not use tap/faucet water, or any non-purified bottled water, other beverages, or liquids.
Empty buffer component packet contents into cup. Effervescence will occur.
Stir until the buffer component completely dissolves. For children 2 through 5 years of age, discard half of the buffer solution after mixing.
Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution.
Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates. If desired, no more than 4 g (1 teaspoon) of sucrose (table sugar) or no more than 1 g (1/4 teaspoon) of non-flavored stevia sweeteners may be added and stirred into the suspension. Do not add any other sweeteners or medicinal flavorings as this can reduce the effectiveness of the vaccine.
Consume Vaxchora within 30 minutes, if sucrose or non-flavored stevia are added. Consume Vaxchora within 4 hours of reconstitution, if sucrose and non-flavored stevia have not been added, at room temperature around 70 °F (21°C). The recipient should drink the full contents of the cup. Some residue may remain in the cup and should be discarded with the cup.

Vaxchora Contraindications

Contraindications

Severe allergic reaction to any previous cholera vaccine.

Vaxchora Boxed Warnings

Not Applicable

Vaxchora Warnings/Precautions

Warnings/Precautions

Immunocompromised, elderly (≥65yrs). Considering whether to administer to individuals with immunocompromised close contacts. Pregnancy.

Pregnancy Considerations

Risk Summary

Vaxchora is not absorbed systemically, and it is not expected to result in fetal exposure to the drug.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk: Maternal cholera disease is associated with adverse outcomes including fetal death.
Fetal/neonatal adverse reactions: Risk for transmitting the vaccine strain from mother to infant during vaginal delivery.

Nursing Mother Considerations

Risk Summary

Vaxchora is not absorbed systemically, and it is not expected to result in exposure of the child to Vaxchora.

Pediatric Considerations

Safety and efficacy have not been established in children younger than 2 years of age.

Geriatric Considerations

Safety and efficacy have not been established in adults 65 years of age or older.

Other Considerations for Specific Populations

Immunocompromised Individuals

Safety and efficacy have not been established in immunocompromised individuals. These individuals may get suboptimal immune responses.

Vaxchora Pharmacokinetics

See Literature

Vaxchora Interactions

Interactions

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.

Vaxchora Adverse Reactions

Adverse Reactions

Tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, diarrhea.

Vaxchora Clinical Trials

Clinical Trials

Efficacy Against V. cholerae Challenge

Study 2

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.

Immunogenicity

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.
Study 2

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.

Study 1

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.

Study 4

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)

Study 5

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.

Vaxchora Note

Notes

To enroll patients in the pregnancy exposure registry call (800) 533-5899.

Vaxchora Patient Counseling

Patient Counseling

Exercise caution regarding food and water consumed in cholera-affected areas.
Advise patients regarding the most common adverse reactions will occur within 7 days after vaccination. These reactions include tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.
Inform vaccine recipients of the potential for transmission of the vaccine strain to close contacts (eg, household contacts). Vaccine recipients should wash hands thoroughly after using the bathroom and before preparing or handling food for at least 14 days after vaccination.

Vaxchora

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