Vivotif

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vivotif Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Oral typhoid vaccine live, attenuated strain Ty21a; e-c caps.

    Pharmacological Class

    Typhoid vaccine.

    How Supplied

    Caps—4

    Storage

    Store between 2 °C and 8 °C (35.6 °F–46.4 °F). Vivotif is not stable when exposed to ambient temperatures.

    Manufacturer

    Bavarian Nordic, Inc.

    Mechanism of Action

    The S. typhi Ty21a vaccine strain, by virtue of a reduction in enzymes essential for lipopolysaccharide biosynthesis, is restricted in its ability to produce complete lipopolysaccharide. However, a sufficient quantity of complete lipopolysaccharide is synthesized to evoke a protective immune response. Despite low levels of lipopolysaccharide synthesis, the cells lyse before regaining a virulent phenotype due to the intracellular build-up of intermediates during lipopolysaccharide synthesis.

    Vivotif Indications

    Indications

    Immunization against typhoid fever.

    Indications

    Selective immunization against typhoid fever is recommended for the following groups:

    • Travelers to areas in which there is a recognized risk of exposure to S. typhi.
    • Individuals with intimate exposure to a S. typhi carrier.
    • Microbiology laboratorians who work frequently with S. typhi.

    There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.

    Limitations of Use

    The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. 

    The vaccine is not suitable for treatment of acute infections with S. typhi.

    Vivotif Dosage and Administration

    Adults and Children

    Do not crush or chew. Give 1 hour before a meal with cold or lukewarm (not >body temp) drink. Complete therapy at least 1 week before expected exposure; may repeat every 5yrs. <6yrs: not recommended. ≥6yrs: 1 cap every other day for a total of 4 doses.

    Administration

    Inspect the blister containing the vaccine capsules to ensure the foil seal and capsules are intact.

    Capsules should be swallowed whole; do not chew. 

    One capsule should be swallowed approximately 1 hour before a meal with a cold or lukewarm drink on alternate days, eg, days 1, 3, 5 and 7.

    Vivotif Contraindications

    Contraindications

    Acute febrile or GI illness. Immunocompromised states. 

    Vivotif Boxed Warnings

    Not Applicable

    Vivotif Warnings/Precautions

    Warnings/Precautions

    Defer in active infection, fever, persistent diarrhea, or vomiting. Exposure to contaminated food and water should be avoided. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    Only administer Vivotif to pregnant women if clearly needed. It is not known whether the vaccine causes fetal harm or affects reproduction capacity.

    Nursing Mother Considerations

    It is not known whether Vivotif is excreted in human milk.

    Pediatric Considerations

    The safety and efficacy of Vivotif have not been established in children under 6 years of age.

    Vivotif Pharmacokinetics

    See Literature

    Vivotif Interactions

    Interactions

    Do not administer in patients receiving sulfonamides and antibiotics. Certain anti-malaria drugs may interfere with immunogenicity.

    Interactions

    Sulfonamides and antibiotics may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response.

    Concomitant treatment with mefloquine or chloroquine did not result in a significant reduction in the serum anti-S. typhi immune response and may be administered together with Vivotif.

    Simultaneous administration of proguanil (not approved in the US) did result in a significant decrease in the immune response rate. Proguanil should be administered only if 10 days or more have elapsed since the final dose of Vivotif was ingested.

    Concomitant administration of oral polio vaccine or yellow fever vaccine does not suppress the immune response elicited by the Ty21a vaccine strain.

    Vivotif Adverse Reactions

    Adverse Reactions

    Nausea, abdominal cramps, vomiting, rash, urticaria (all infrequent and transient).

    Vivotif Clinical Trials

    Clinical Trials

    The efficacy of the S. typhi Ty21a strain has been evaluated in a series of randomized, double-blind, controlled field trials. Vaccine efficacy was found to be highest with the 4 dose regimen.

    Because of the very low incidence of typhoid fever in United States citizens, efficacy studies are not currently feasible in this population. It is expected that Vivotif will provide protection to recipients from non-typhoid endemic areas such as the United States.

    Vivotif Note

    Not Applicable

    Vivotif Patient Counseling

    Patient Counseling

    It is essential that all 4 doses of vaccine be taken at the prescribed alternate day interval.

    Swallow vaccine capsule approximately 1 hour before a meal with a cold or lukewarm drink; do not chew the vaccine capsule. The capsule should be swallowed after placing in the mouth as soon as possible.

    Take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water; not all vaccine recipients will be fully protected against typhoid fever.

    Report use of antimalaria medications; some may interfere with the immunogenicity of Vivotif.

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