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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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

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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Toxicity

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.
DrugInteraction
AbacavirThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Abacavir.
AbataceptThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Abatacept.
Acetic acidThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acetic acid.
Acetyl sulfisoxazoleThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acetyl sulfisoxazole.
AcyclovirThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Acyclovir.
AdalimumabThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Adalimumab.
Adefovir dipivoxilThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Adefovir dipivoxil.
AlclometasoneThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Alclometasone.
AldesleukinThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Vibrio cholerae CVD 103-HgR strain live antigen can be decreased when used in combination with Alefacept.
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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

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Cholera Vaccine Strain 35a-and 41 8000m/ccSuspension8000 m / mLSubcutaneousAventis Pasteur Limited1942-12-312001-07-19Canada flag
VaxchoraKit; Powder, for suspension1200000000 [CFU]/1OralEmergent Travel Health Inc.2020-02-13Not applicableUS flag
Vaxchora400000000 cellsOralEmergent Netherlands B.V.2020-12-21Not applicableEU flag
VaxchoraKit1200000000 [CFU]/1OralPaxvax, Inc.2016-10-03Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
V9G528E9E0
CAS number
1704499-30-8

References

General References
  1. 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]
  2. 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]
  3. FDA Approved Drug Products: Vaxchora (cholera vaccine, live, oral) oral suspension [Link]
  4. EMA Summary of Product Characteristics: Vaxchora (Cholera vaccine, recombinant, live) powder for oral suspension [Link]
  5. European Medicines Agency Medicines: Vaxchora (cholera vaccine, oral, live) [Link]
RxNav
1812935

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionCholera (Disorder)3
4CompletedPreventionCholera (Disorder) / Vibrio Cholerae1
4CompletedPreventionCholera (Disorder) / Vibrio Cholerae Infection1
4CompletedPreventionVibrio Cholerae1
4RecruitingBasic ScienceTyphoid and/or Cholera Vaccination1
4RecruitingPreventionCholera (Disorder) / Vibrio Cholerae Infection1
4TerminatedBasic ScienceCholera Vaccination1
3CompletedPreventionCholera (Disorder)1
3CompletedPreventionCholera (Disorder) / Diarrhea / Vibrio Infections1
3CompletedPreventionPrevention Harmful Effects1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionSubcutaneous8000 m / mL
KitOral1200000000 [CFU]/1
Kit; powder, for suspensionOral1200000000 [CFU]/1
Powder, for suspensionOral1200000000 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