Vibrio cholerae CVD 103-HgR strain live antigen

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Overview

Description: A vaccine used in children and adults to prevent cholera caused by a certain strain of bacteria.
Description: A vaccine used in children and adults to prevent cholera caused by a certain strain of bacteria.
DrugBank ID: DB14443
Type: Biotech
US Approved: YES
Other Approved: YES
Patents: 0
Indicated Conditions: 1
Clinical Trials: Phase 0
0
Phase 1
2
Phase 2
9
Phase 3
9
Phase 4
15

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

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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

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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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