Indications for: IMOVAX

Preexposure immunization and postexposure treatment of rabies.

Clinical Trials:

Pre-exposure immunization

  • Imovax demonstrated high antibody responses in human diploid cells in clinical trials conducted in England, Germany, France, and Belgium. Seroconversion was often obtained after one dose. After 2 doses (1 month apart), 100% of recipients developed specific antibody, and the geometric mean titer of the group was approximately 10 international units.

  • In the US, Imovax Rabies vaccine resulted in geometric mean titers (GMT) of 12.9 IU/mL at Day 49 and 5.1 IU/mL at Day 90 when 3 IM doses were given during the course of 1 month. The range of antibody responses was 2.8 to 55.0 IU/mL at Day 49 and 1.8 to 12.4 IU at Day 90. 

Post-exposure immunization

  • The post-exposure efficacy of Imovax Rabies vaccine was based on clinical experience in Iran in which six 1.0mL doses were given on days 0, 3, 7, 14, 30, and 90, in conjunction with antirabies serum. There were 45 individuals severely bitten by rabid dogs and wolves who received Imovax within hours of and up to 14 days after the bites. All individuals were fully protected against rabies. 

  • In studies conducted by the US CDC, 1 dose of Rabies Immune Globulin (RIG) and 5 doses of HDCV elicited an excellent antibody response in all 511 recipients who were bitten by proven rabid animals and so treated, none developed rabies.

Adults and Children:

Administer IM in the deltoid (for adults and older children) and the anterolateral aspect of the thigh may be preferable (for infants and small children). Preexposure: 3 inj of 1mL IM each on day 0, 7, and either day 21 or 28. Booster doses: 1mL every 2 yrs (see literature). Postexposure treatment: a 5 dose regimen of 1mL IM given on days 0, 3, 7, 14, 28 or 30 (WHO or ACIP recommendations), and 90 (give 1st dose with rabies immune globulin). If previously immunized against rabies, only 2 doses are given, immediately after exposure, and 3 days later (no rabies immune globulin needed).

IMOVAX Warnings/Precautions:

Postpone preexposure immunization during acute febrile illness or infection. Immunocompromised: may get suboptimal response (monitor titers). Have epinephrine inj (1:1000) available. Pregnancy. Nursing mothers.

IMOVAX Interactions:

Immunosuppressants: may get suboptimal response.

Adverse Reactions:

Local reactions (pain, erythema, swelling), systemic reactions (nausea, headache, muscle aches, abdominal pain).

How Supplied:

Single-dose vial (1mL)—1 (w. syringe and diluent)