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Vaccine Detail

JE-Vax
Vaccine Information
  • Product Name: Japanese Encephalitis Virus Vaccine Inactivated
  • Tradename: JE-Vax
  • Manufacturer: Research Foundation for Microbial Diseases of Osaka University, License #1156
  • Vaccine Ontology ID: VO_0000066
  • CDC CVX code: 39
  • Type: Inactivated or "killed" vaccine
  • Status: Licensed
  • Location Licensed: USA
  • Host Species for Licensed Use: Human
  • Antigen: Inactivated Japanese encephalitis (JE) virus “Nakayama-NIH” strain
  • Preparation: JE-VAX is prepared by inoculating mice intracerebrally with Japanese encephalitis (JE) virus, “Nakayama-NIH” strain. Infected brains are harvested and homogenized in PBS, pH 8.0. The homogenate is centrifuged and the supernatant inactivated with formaldehyde, then processed to yield a partially purified, inactivated virus suspension. This is further purified by ultra-centrifugation through 40% w/v sucrose. The suspension is then lyophilized. Thimerosal (mercury derivative) is added as a preservative to a final concentration of 0.007%. The diluent sterile water for Injection contains no preservative. Each 1.0 mL dose contains approximately 500 μg of gelatin, less than 100 μg of formaldehyde, less than 0.0007% v/v Polysorbate 80, and less than 50 ng of mouse serum protein. No myelin basic protein can be detected at the detection threshold of the assay (<2 ng/mL). Prior to reconstitution, the vaccine is a white caked powder. After reconstitution, the vaccine is a colorless transparent liquid (FDA: JE-Vax).
  • Immunization Route: subcutaneous injection
  • Storage: The vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. After reconstitution the vaccine should be stored at 2° to 8°C (35° to 46°F) and used within 8 hours. DO NOT FREEZE RECONSTITUTED VACCINE.
  • Approved Age for Licensed Use: Age 1 year and older
  • Contraindication: Adverse reactions to a prior dose of JE vaccine manifesting as generalized urticaria and angioedema and should not be administered to persons with a proven or suspected hypersensitivity to proteins of rodent or neural origin. (FDA: JE-Vax).
  • Description: JE-VAX is a sterile, lyophilized vaccine for subcutaneous use Ref747:FDA: Jevax].
Host Response

Human Response

  • Vaccination Protocol: In a placebo-controlled, randomized clinical trial in Thai children, sponsored by the US Army. In this trial, children between 1 and 14 years of age received BIKEN monovalent Nakayama-NIH strain (n = 21,628) or a bivalent vaccine containing the Nakayama-NIH and Beijing JE virus strains (n = 22,080) or tetanus toxoid as a placebo (n = 21,516) (FDA: JE-Vax).
  • Side Effects: Side effects that were reported included: headache, sore arm, rash, and swelling
  • Efficacy: One case (5 cases/100,000) of Japanese encephalitis (JE) occurred in the monovalent vaccine group, one case (5 cases/100,000) in the bivalent vaccine group, and 11 cases (51 cases/100,000) in the placebo group. The observed efficacy of both monovalent and bivalent vaccines was 91% (FDA: JE-Vax).
  • Description: JE-VAX should be considered for use in persons who plan to reside in or travel to areas where JE is endemic or epidemic during a transmission season
References
FDA: JE-Vax: FDA: JE-Vax vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094048.htm]