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Cholera Vaccine

Pronunciation

(KOL er a vak SEEN)

Index Terms

  • CVD 103-HgR
  • Vaxchora

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Oral:

Vaxchora: Vibrio cholerae 4x108 to 2x109 CFU (100 mL)

Brand Names: U.S.

  • Vaxchora

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Bacterial)

Pharmacology

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

Efficacy: In a study of adults 18 to 45 years of age, the efficacy against the occurrence of moderate to severe diarrhea was 90.3% at 10 days post-vaccination and 79.5% at 3 months post-vaccination.

Absorption

Oral: No systemic absorption.

Excretion

Feces

Use: Labeled Indications

Cholera prevention: Active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following: Adult travelers (aged 18 to 64 years) from the US to an area of active cholera transmission (ACIP [Wong 2017]).

Limitations of use: Effectiveness has not been established in persons living in cholera-affected areas or in persons who have preexisting immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to any component of the formulation or to a previous dose of any cholera vaccine

Dosing: Adult

Cholera prevention: Oral: 100 mL (single dose) administered ≥10 days prior to potential cholera exposure.

Reconstitution

Prepare and administer in a health care setting equipped to dispose of medical waste. Complete reconstitution within 15 minutes of removing the carton from the freezer (freezer formulation) or refrigerator (refrigerated formulation); freezer formulation does not require thawing prior to reconstitution. Pour 100 mL of cold or room temperature purified or spring bottled water into a clean, disposable cup. Do not use tap water, sparkling (carbonated) water, nonpurified or nonspring bottled water, other beverages, or other liquids. Empty buffer component packet contents into cup; stir until completely dissolved. Effervescence will occur. Add the active component packet contents into the cup containing the buffer solution; stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension (may not dissolve completely and may contain some white particulates). Note: If packets are reconstituted in the improper order, the vaccine must be discarded.

Administration

Oral: Avoid eating or drinking for 60 minutes before and after oral ingestion. Consume vaccine within 15 minutes of reconstitution; drink full contents of the cup at once; discard any residue that may remain in cup after consumption. If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Storage

Freezer formulation: Store buffer and active component packets frozen at -25°C to -15°C (-13°F to 5°F). Protect from light and moisture. Packets should not be out of frozen storage for more than 15 minutes prior to reconstitution; when out of frozen storage, packets should not be exposed to temperatures above 27°C (80°F).

Refrigerated formulation: Store buffer and active component packets refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light and moisture. Packets should not be out of refrigerated storage for more than 15 minutes prior to reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 27°C (80°F).

Drug Interactions

Antibiotics: May diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Exceptions: Acetic Acid (Otic); Acetic Acid (Topical); Aluminum Acetate; Azithromycin (Ophthalmic); Aztreonam (Oral Inhalation); Bacitracin (Ophthalmic); Bacitracin (Topical); Benzoin; Chlortetracycline; Ciprofloxacin (Ophthalmic); Clindamycin (Topical); Dapsone (Topical); Dibrompropamidine (Ophthalmic); Dibrompropamidine (Topical); Erythromycin (Ophthalmic); Erythromycin (Topical); Fidaxomicin; Framycetin; Fusidic Acid (Ophthalmic); Fusidic Acid (Topical); Gatifloxacin; Gentamicin (Ophthalmic); Gentamicin (Topical); Gentian Violet; Hexachlorophene; Mafenide; MetroNIDAZOLE (Topical); Mupirocin; Neomycin; Nitrofurazone; Oxychlorosene; Ozenoxacin; Povidone-Iodine (Topical); RifAXIMin; Silver Nitrate; Sulfacetamide (Ophthalmic); Sulfacetamide (Topical); Taurolidine; Tobramycin (Ophthalmic). Avoid combination

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Brexucabtagene Autoleucel: May enhance the adverse/toxic effect of Vaccines (Live). Brexucabtagene Autoleucel may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Chloroquine: May diminish the therapeutic effect of Cholera Vaccine. Management: Administer cholera vaccine at least 10 days prior to initiation of chloroquine. Consider therapy modification

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone >2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Exceptions: Deflazacort. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Deflazacort: May enhance the adverse/toxic effect of Vaccines (Live). Deflazacort may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating deflazacort. Live vaccines should be administered at least 4 to 6 weeks prior to initiating deflazacort. Consider therapy modification

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

Adverse Reactions

>10%:

Central nervous system: Fatigue (31%), headache (29%)

Gastrointestinal: Abdominal pain (19%), nausea and vomiting (18%)

1% to 10%: Gastrointestinal: Diarrhea (4%)

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices (ACIP) recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Ezeanolue 2020]).

Special populations:

• Altered immunocompetence: Severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; safety and effectiveness have not been established and immunocompromised patients may have a reduced response to vaccination or may have an adverse event secondary to replication (ACIP [Ezeanolue 2020]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live, attenuated vaccines should not be administered for at least 3 months after immunosuppressive therapy (IDSA [Rubin 2014]).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

• Transmission of virus: Bacteria may be shed in the stool of the recipient for at least a week. For ≥14 days following vaccination, recipient should wash their hands thoroughly after using the bathroom and before preparing or handling food. The manufacturer recommends caution when considering use in individuals with close contact to immunocompromised persons.

Pregnancy Considerations

The cholera vaccine is not systemically absorbed following maternal oral administration and is not expected to result in fetal exposure. Following administration, the vaccine's bacteria may be shed in the maternal stool for ≥7 days, potentially exposing the newborn to the vaccine strain during vaginal delivery. Maternal cholera infection is associated with adverse pregnancy outcomes, including fetal death.

Health care providers are encouraged to enroll women exposed to the cholera vaccine during pregnancy in the Pregnancy Registry (800-533-5899).

Patient Education

What is this drug used for?

• It is used to prevent cholera.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loss of strength and energy

• Headache

• Abdominal pain

• Nausea

• Vomiting

• Lack of appetite

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.