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Vaccine Detail

Vivotif
Vaccine Information
  • Vaccine Name: Vivotif
  • Target Pathogen: Salmonella spp.
  • Target Disease: Salmonellosis
  • Product Name: Typhoid Vaccine Live Oral Ty21a
  • Tradename: Vivotif
  • Manufacturer: Berna Biotech, Ltd
  • Vaccine Ontology ID: VO_0000120
  • CDC CVX code: 25
  • Type: Live, attenuated vaccine
  • Status: Licensed
  • Location Licensed: USA (License # 1632)
  • Host Species for Licensed Use: Human
  • Antigen: The antigen is live, attenuated strain Ty21a (Levine et al., 2007).


  • Preparation: Ty21a in enteric-coated capsules was created with 2 × 109–5 × 109 cfu of Ty21 (Levine et al., 2007).
  • Immunization Route: Oral
  • Storage: between 2 °C and 8 °C (35.6 °F– 46.4 °F).
  • Approved Age for Licensed Use: 6 years of age and older.
  • Contraindication: Hypersensitivity to any component of the vaccine or the enteric-coated capsule (FDA: Vivotif).
  • Description: Indication: VIVOTIF is used for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi (FDA: Vivotif).
Host Response

Human Response

  • Vaccination Protocol: Two trials were completed with Ty21a: In the first, Participants were randomly allocated to receive, 1 week apart, either 2 doses of Ty21a in enteric-coated capsules, 1 dose of Ty21a and 1 dose of placebo, or 2 doses of placebo. In the second, participants were randomly allocated to receive 3 doses of vaccine in 1 of 2 different formulations or placebo. One formulation of Ty21a was enteric-coated capsules, and the other was a triad of gelatin capsules, with 1 containing lyophilized vaccine and the other 2 containing NaHCO3 buffer.
  • Persistence: Not noted.
  • Immune Response: Doses of Ty21a in capsules stimulates a form of antibody-dependent cellular cytotoxicity, in which IgA antibodies provide the specificity for cells to kill Salmonella organisms. Ty21a stimulates strong classical cell-mediated immune responses involving specific T cells that are believed to function through different effector mechanisms, such as production of IFN-gamma and other cytokines when stimulated by inactivated whole bacilli and purified S. Typhi flagella and the appearance of cytotoxic T cells that kill target cells infected with S. Typhi (Levine et al., 2007). Unless a complete immunization schedule is followed, an optimum immune response may not be achieved (FDA: Vivotif).
  • Side Effects: The most common side effects reported were: abdominal pain, nausea, headache, fever, diarrhea, vomiting and skin rash (FDA: Vivotif).
  • Efficacy: Results from clinical studies indicate that adults and children greater than 6 years of age may be protected against typhoid fever following the oral ingestion of 4 doses of VIVOTIF (FDA: Vivotif).
References
FDA: Vivotif: FDA: Vivotif Vaccine for Salmonella [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094070.htm]
Levine et al., 2007: Levine MM, Ferreccio C, Black RE, Lagos R, San Martin O, Blackwelder WC. Ty21a live oral typhoid vaccine and prevention of paratyphoid fever caused by Salmonella enterica Serovar Paratyphi B. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2007; 45 Suppl 1; S24-28. [PubMed: 17582564].