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Japanese Encephalitis Virus VaccinePronunciation: en-se-fa-LI-tes
Class: Viral vaccine
- Injection, lyophilized powder for suspension. Each mL contains mouse serum protein less than 50 ng, gelatin approximately 500 mcg, and formaldehyde less than 100 mcg
- Injection, suspension 6 mcg per 0.5 mL
Inactivated virus vaccine that induces neutralizing antibodies to Japanese encephalitis (JE) virus.
Immunity develops by 10th day after primary vaccination for JE-Vax and by the 7th day for Ixiaro .
Full duration of protection is unknown. A booster dose is recommended after 2 yr of primary series.
Indications and Usage
Active immunization for JE for persons 1 yr of age and older ( JE-Vax ) and for persons 17 yr of age and older ( Ixiaro ).
History of hypersensitivity to prior dose.JE-Vax
Hypersensitivity to thimerosal; hypersensitivity to proteins of rodent or neural origin.
Dosage and AdministrationIxario
IM 2 doses of 0.5 mL IM 28 days apart. Complete immunization series at least 1 week prior to exposure to JE virus.JE-Vax
Adults and children 3 yr of age and older
Subcutaenously 3 doses of 1 mL subcutaneously on days 0, 7, and 30. The last dose should be given at least 10 days before exposure to JE virus. A booster dose of 1 mL may be given after 2 yr. Only under unusual circumstances, 2 doses may be given a week apart.Children 1 to 3 yr of age
Subcutaenously 3 doses of 0.5 mL subcutaneously on days 0, 7, and 30. An abbreviated schedule of days 0, 7, and 14 may used because of time constraints. A booster dose of 0.5 mL may be given after 2 yr.
- Administer JE-Vax subcutaneously and Ixiaro by IM into the deltoid muscle. Do not administer IV or intradermally.
- Before administering Ixiaro , shake the syringe well to obtain a white, opaque, homogenous suspension.
- Do not mix with any other vaccine in the same syringe or vial.
- Administer JE-Vax vaccine within 8 h after reconstitution.
Store vaccine between 35° and 46°F. Do not freeze. Use reconstituted JE-Vax within 8 h. During storage of Ixiaro , a clear liquid with a white precipitate can be observed.
None well documented.
Laboratory Test Interactions
None well documented.
Headache (28%); fatigue (11%), migraine (at least 1%).JE-Vax
Nausea (7%); diarrhea, vomiting (2%).
Angioedema of the extremities and face, especially of the lips and oropharynx; erythema multiforme; erythema nodosum; joint swelling; generalized itching.
Tenderness (36%); pain (33%); erythema (10%); induration (8%); edema; pruritus (4%).JE-Vax
Arm soreness and redness (25%); rash (5%).
Myalgia (16%); back pain (1%).
Nasopharyngitis (5%); pharyngolaryngeal pain, upper respiratory tract infection (2%); sinusitis (at least 1%); cough, rhinitis (1%).
Influenza-like illness (12%); pyrexia (3%); rash (1%).JE-Vax
Febrile episode (6%); flu-like symptoms (less than 5%).
Monitor patient for possible adverse reactions. Report suspected adverse reactions following immunization to the Vaccine Adverse Event Reporting System.
Category B ( Ixiaro ), Category C ( JE-Vax ).
Safety and efficacy not established in children younger than 1 yr of age ( JE-Vax ); safety and efficacy not established in children younger than 17 yr of age ( Ixiaro ).
Do not administer to patients with history of acute hypersensitivity to eggs or egg products; anaphylaxis may occur. Anaphylaxis also may occur in persons with no prior history of hypersensitivity to the vaccine components. Ensure that epinephrine injection (1:1,000) is always immediately available.
Immunocompromised patients may have a diminished immune response.
The precise relationship between antibody level and efficacy has hot been established, even though these antibody titers persisted for at least 2 yr after immunization.
- Instruct patients to complete a 3-dose immunizing series for JE-Vax and a 2-dose immunizing series for Ixiaro , except in unusual circumstances.
- Advise patients with a history of hives (following hymenoptera envenomation, drugs, physical or other provocation, or of idiopathic origin) that adverse reactions are more likely.
- Inform patients that adverse reactions consisting of headache, rash, edema, and generalized urticaria or angioedema may occur shortly after vaccination or up to 17 days (usually within 10 days) following vaccination.
- Advise patient or caregiver that injection-site reactions consisting of arm soreness and local redness may occur shortly after vaccination.
- Advise patient or caregiver to use non–aspirin-containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, muscle aches, pain, or discomfort at injection site.
- Inform patients that the vaccine may not fully protect everyone who receives the vaccine and to take precautions to avoid exposure to mosquito bites.
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