Vaxchora Active Component (cholera vaccine, live)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Cholera vaccine is commercially available in the US as an oral live, attenuated bacterial vaccine containing Vibrio cholerae (V. cholerae) strain CVD 103-HgR derived from V. cholerae serogroup O1. Cholera vaccine live oral is used to stimulate active immunity against V. cholerae serogroup O1. This is the only cholera vaccine available in the US; other types of oral cholera vaccines may be available in other countries.
Cholera vaccine live oral contains live, attenuated Vibrio cholerae(V. cholerae) strain CVD 103-HgR and is used to stimulate active immunity to V. cholerae serogroup O1.
The V. cholerae CVD 103-HgR vaccine strain is constructed from the V. cholerae serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of the toxigenic cholera toxin A subunit gene (ctxA), which prevents the vaccine strain from synthesizing active cholera toxin. The vaccine strain remains able to synthesize the nontoxic, immunogenic cholera toxin B subunit gene (ctxB). In addition, a unique phenotypic marker is inserted into the hemolysin gene locus (hylA) to enable differentiation of the vaccine strain from wild-type V. cholerae serogroup O1.
The V. cholerae CVD 103-HgR vaccine strain is grown in a medium consisting of casamino acids, yeast extract, mineral salts, and an anti-foaming agent; the vaccine strain is collected by filtration and is diafiltered and concentrated.
The bacteria are concentrated by ultrafiltration before addition of a stabilization solution containing ascorbic acid (an antioxidant), Hy-Case SF (hydrolyzed casein (a protein derived from cow's milk), a cryoprotectant), and sucrose (a cryoprotectant). The stabilized bacteria are lyophilized, milled, and blended with anhydrous lactose (a bulking agent). The active component blend is filled into packets.
The buffer component is manufactured by blending together sodium bicarbonate (a gastric acid neutralizer), sodium carbonate (a buffer), ascorbic acid (a buffer and water chlorine neutralizer), and anhydrous lactose (a manufacturing flow aid). The buffer component blend is filled into packets.
Following oral administration of cholera vaccine live oral, the live, attenuated V. cholerae CVD 103-HgR vaccine strain replicates in the GI tract and induces a local mucosal immune response in the small intestine. The exact immunologic mechanism by which cholera vaccine live oral provides protection against V. cholerae serogroup O1 has not been determined, but is thought to be related to immune responses at the intestinal mucosal surface. Because intestinal immunity cannot be easily measured in clinical trials, serum vibriocidal antibodies have been used as a surrogate marker to indicate an immune response to cholera vaccine live oral.
In studies in adults 18-45 years of age, serum vibriocidal antibody was detected within 10 days following a single dose of cholera vaccine live oral and approximately 90-94% of vaccinees seroconverted after a single vaccine dose. Seroconversion in these studies was defined as a 4-fold or greater increase in serum vibriocidal antibody titers from baseline to day 10 after vaccination. The seroconversion rate in adults 46-64 years of age appears to be similar to that in adults 18-45 years of age.
The seroconversion rate in pediatric patients 2-17 years of age was 98.5% after a single dose.
Cholera vaccine live oral is not absorbed systemically following oral administration. Approximately 11% of adults who receive a single dose of cholera vaccine live oral shed the vaccine strain of V. cholerae in their stools for at least 7 days after the vaccine dose.
USES: This vaccine is used to help prevent cholera infection. People can get cholera by eating food or drinking water that has been contaminated. This vaccine is recommended for people who are traveling to areas where this infection is common.
This vaccine contains live bacteria that have been weakened. It works by increasing the body's natural defense (immunity) against the bacteria. Vaccines may not fully protect everyone who receives them.
While traveling, you should still avoid contaminated food or water (such as by drinking only bottled or boiled water, eating only fully cooked food). Ask your health care professional for more details.
Generic name: cholera vaccine, live
Pronunciation: (KOL-er-a)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Vaxchora Active Component
Indications
The following indications are listed for Vaxchora Active Component:
- Cholera Vaccination
Also known as: Active Immunization Against Vibrio Cholerae, Active Immunization For The Prevention Of Cholera, Cholera Prevention, Cholera Prophylaxis.
Dosing
No dosing information is available for this tab.
Cholera vaccine live oral is administered as an oral suspension.
Vaccine recipients should be instructed to avoid eating or drinking for 60 minutes before and after ingestion of cholera vaccine live oral. Cholera vaccine live oral is provided by the manufacturer in a single-dose carton that contains a foil packet of lyophilized live, attenuated Vibrio cholerae (V. cholerae) CVD 103-HgR (active component) and a foil packet of dry powder buffer (buffer component). These 2 components must be reconstituted and mixed together according to the manufacturer's instructions to provide an oral suspension containing cholera vaccine live oral.
Following reconstitution, 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. If sucrose and non-flavored stevia are added, administer the final oral suspension containing cholera vaccine live oral within 30 minutes after preparation. If sugar or sweetener has not been added, administer the final oral suspension within 4 hours of reconstitution at room temperature (~21degreesC). Ensure the entire contents of the cup (100 mL) is swallowed at one time.
The packets containing the active component and buffer component should be stored in the original carton, refrigerated at 2-8degreesC, and protected from light and moisture. Packages may be stored at 9-25degreesC for no more than 24 hours prior to reconstitution.
Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees. All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained. Vaccine that has been mishandled or has not been stored at the recommended temperature should not be administered. If there are concerns about mishandling, the manufacturer or state or local health departments should be contacted for guidance on whether the vaccine is usable.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any cholera vaccine.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in more than 3% of adults following a single dose of cholera vaccine live oral include tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%), and diarrhea (4%).
Adverse effects reported in pediatric patients 12 to <18 years of age following a single dose of cholera vaccine live oral include headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%), and nausea (22%).
Adverse effects reported in pediatric patients 6 to <12 years of age following a single dose of cholera vaccine live oral include tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%), and nausea (14%).
Adverse effects reported in pediatric patients 2 to <6 years of age following a single dose of cholera vaccine live oral include tiredness (31%), loss of appetite (19%), and abdominal pain (17%).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of cholera vaccine live oral have not been established in pediatric patients younger than 2 years of age.
Data are not available to date regarding use of cholera vaccine live oral in pregnant women.
Because cholera vaccine live oral is not absorbed systemically following oral administration, vaccination during pregnancy is not expected to result in fetal exposure to the vaccine.
Clinicians should consider that cholera infection is associated with adverse pregnancy outcomes, including fetal death. Clinicians also should consider that the vaccine strain of V. cholerae may be shed in the stools of vaccinated mothers for at least 7 days after vaccination and there is potential for transmission of the vaccine strain from the mother to the infant during vaginal delivery.
Data are not available to date regarding use of cholera vaccine live oral in nursing women.
Because cholera vaccine live oral is not absorbed systemically following oral administration, vaccination in nursing women is not expected to result in exposure to the vaccine in breast-fed infants.
Cholera vaccine live oral is not indicated in adults 65 years of age or older.
Safety and efficacy of cholera vaccine live oral have not been established in adults 65 years of age or older.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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