Japanese Encephalitis Virus Vaccine

Pronunciation: en-se-fa-LI-tes
Class: Viral vaccine

Trade Names

JE-Vax
- 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

Ixario
- Injection, suspension 6 mcg per 0.5 mL

Pharmacology

Inactivated virus vaccine that induces neutralizing antibodies to Japanese encephalitis (JE) virus.

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Pharmacokinetics

Onset

Immunity develops by 10th day after primary vaccination for JE-Vax and by the 7th day for Ixiaro .

Duration

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 ).

Contraindications

History of hypersensitivity to prior dose.

JE-Vax

Hypersensitivity to thimerosal; hypersensitivity to proteins of rodent or neural origin.

Dosage and Administration

Ixario
Adults

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.

General Advice

  • 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.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Ixiaro

Headache (28%); fatigue (11%), migraine (at least 1%).

JE-Vax

Headache (15%).

GI

Ixiaro

Nausea (7%); diarrhea, vomiting (2%).

Hypersensitivity

JE-Vax

Angioedema of the extremities and face, especially of the lips and oropharynx; erythema multiforme; erythema nodosum; joint swelling; generalized itching.

Local

Ixiaro

Tenderness (36%); pain (33%); erythema (10%); induration (8%); edema; pruritus (4%).

JE-Vax

Arm soreness and redness (25%); rash (5%).

Musculoskeletal

Ixiaro

Myalgia (16%); back pain (1%).

Respiratory

Ixiaro

Nasopharyngitis (5%); pharyngolaryngeal pain, upper respiratory tract infection (2%); sinusitis (at least 1%); cough, rhinitis (1%).

Miscellaneous

Ixiaro

Influenza-like illness (12%); pyrexia (3%); rash (1%).

JE-Vax

Febrile episode (6%); flu-like symptoms (less than 5%).

Precautions

Monitor

Monitor patient for possible adverse reactions. Report suspected adverse reactions following immunization to the Vaccine Adverse Event Reporting System.


Pregnancy

Category B ( Ixiaro ), Category C ( JE-Vax ).

Lactation

Undetermined.

Children

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 ).

Hypersensitivity

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.

Immunosuppressed patients

Immunocompromised patients may have a diminished immune response.

Vaccine efficacy

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.

Overdosage

Symptoms

None reported.

Patient Information

  • 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.

Copyright © 2009 Wolters Kluwer Health.

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