Identification
- Summary
Vibrio cholerae CVD 103-HgR strain live antigen is a live, attenuated vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.
- Brand Names
- Vaxchora
- Generic Name
- Vibrio cholerae CVD 103-HgR strain live antigen
- DrugBank Accession Number
- DB14443
- Background
Vibrio cholerae CVD 103-HgR strain live antigen is a component of Vaxchora, an oral vaccine for immunization against Vibrio cholerae serogroup O1.3 Cholera is an acute bacterial disease of the small intestine caused by Vibrio cholerae, which is gram-negative bacteria. Two serogroups of V. cholerae, O1 and O139, are causative agents of epidemic cholera. Serogroup O1 is responsible for the majority of cholera outbreaks.2 Cholera outbreaks remain a major global public health problem that mainly affects countries with limited access to clean water, poor hygiene, and proper sanitation; thus, effective vaccines to protect individuals against cholera disease are critical.1
The FDA approved the cholera vaccine containing Vibrio cholerae CVD 103-HgR strain live antigen under the brand name Vaxchora in June 2016, making it the first vaccine indicated for cholera prevention to become available in the U.S.2 Vaxchora was later approved by the European Commission in April 2020.5 It is indicated for individuals aged two years and older.3
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Vaccines
Attenuated - Synonyms
- Cholera Vaccine
- Cholera Vaccine Live Oral
- Cholera vaccine, live, oral
Pharmacology
- Indication
Vibrio cholerae CVD 103-HgR strain live antigen is indicated for active oral immunization against infection caused by Vibrio cholerae serogroup O1 in patients between 2 and 64 years of age.3,4
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Cholera caused by vibrio cholerae serogroup o1 •••••••••••• - Contraindications & Blackbox Warnings
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Vibrio cholerae CVD 103-HgR strain live antigen provides active immunization against Vibrio cholerae serogroup O1. The vaccine does not offer effective protection against Vibrio cholerae serogroup O139 or other non-O1 serogroups.2
Live attenuated oral cholera vaccine is associated with a risk of bacterial shedding; therefore, it carries the risk of spreading the pathogen to non-vaccinated close contacts and possibly infecting these individuals.1 Shedding of the vaccine strain in the stool of healthy adults was seen in the first seven days following vaccination; vaccine shedding was highest on day seven. The duration of shedding of the vaccine strain is unknown. After 10 days of vaccination with Vibrio cholerae CVD 103-HgR strain live antigen, a rise in serum vibriocidal antibody titers - indicating immunity and protection against cholera - was observed in a human challenge study.2,3
- Mechanism of action
Vibrio cholerae CVD 103-HgR strain live antigen contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain CVD 103- HgR). As an oral vaccine, it works by mimicking the natural infection of V. cholerae to generate a mucosal gut immune response.1 Upon administration, live attenuate cholera bacteria replicate in the gastrointestinal tract, thereby inducing rapid serum vibriocidal antibody and memory B cell responses. However, the exact immune mechanisms that lead to protection against cholera are not yet determined.3,4 Compared to killed bacterial strains, live strains are more efficiently taken up by M cells in the intestine, which are the major antigen sampling cells in the gut.1
- Absorption
Pharmacokinetic information is not applicable.
- Volume of distribution
Pharmacokinetic information is not applicable.
- Protein binding
Pharmacokinetic information is not applicable.
- Metabolism
Pharmacokinetic information is not applicable.
- Route of elimination
Pharmacokinetic information is not applicable.
- Half-life
Pharmacokinetic information is not applicable.
- Clearance
Pharmacokinetic information is not applicable.
- Adverse Effects
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There is no information on the LD50 of cholera vaccine.
There have been reports of multiple doses of cholera vaccine being administered several weeks apart. The adverse reactions reported were comparable to those seen after the recommended dose.4
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbacavir The therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Abacavir. Abatacept The therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Abatacept. Acetic acid The therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acetic acid. Acetyl sulfisoxazole The therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acetyl sulfisoxazole. Acyclovir The therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acyclovir. - Food Interactions
- Take separate from meals. Avoid food or drink for 60 minutes before and after administration as it may interfere with the protective effect of the vaccine buffer.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Cholera Vaccine Strain 35a-and 41 8000m/cc Suspension 8000 m / mL Subcutaneous Aventis Pasteur Limited 1942-12-31 2001-07-19 Canada 
Vaxchora Kit; Powder, for suspension 1200000000 [CFU]/1 Oral Emergent Travel Health Inc. 2020-02-13 Not applicable US 
Vaxchora 400000000 cells Oral Bavarian Nordic A/S 2020-12-21 Not applicable EU 
Vaxchora Kit 1200000000 [CFU]/1 Oral Paxvax, Inc. 2016-10-03 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- V9G528E9E0
- CAS number
- 1704499-30-8
References
- General References
- Shaikh H, Lynch J, Kim J, Excler JL: Current and future cholera vaccines. Vaccine. 2020 Feb 29;38 Suppl 1:A118-A126. doi: 10.1016/j.vaccine.2019.12.011. Epub 2019 Dec 24. [Article]
- Mosley JF 2nd, Smith LL, Brantley P, Locke D, Como M: Vaxchora: The First FDA-Approved Cholera Vaccination in the United States. P T. 2017 Oct;42(10):638-640. [Article]
- FDA Approved Drug Products: Vaxchora (cholera vaccine, live, oral) oral suspension [Link]
- EMA Summary of Product Characteristics: Vaxchora (Cholera vaccine, recombinant, live) powder for oral suspension [Link]
- European Medicines Agency Medicines: Vaxchora (cholera vaccine, oral, live) [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Prevention Cholera (Disorder) / Vibrio Cholerae Infection 1 4 Completed Prevention Cholera (Disorder) 3 4 Completed Prevention Cholera (Disorder) / Vibrio Cholerae 1 4 Completed Prevention Cholera (Disorder) / Vibrio Cholerae Infection 1 4 Completed Prevention Vibrio Cholerae 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Suspension Subcutaneous 8000 m / mL Kit Oral 1200000000 [CFU]/1 Kit; powder, for suspension Oral 1200000000 [CFU]/1 Powder, for suspension Oral 1200000000 CFU - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at July 05, 2018 18:02 / Updated at January 13, 2022 23:57