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Imovax

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Imovax

CLINICAL PHARMACOLOGY

Pre-exposure Immunization

High titer antibody responses to the Imovax Rabies vaccine made in human diploid cells have been demonstrated in trials conducted in England1, Germany2,3, France4 and Belgium.5 Seroconversion was often obtained with only one dose. With two doses one month apart, 100% of the 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 three doses were given intramuscularly during the course of one 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 90.6 The definition of a minimally accepted antibody titer varies among laboratories and is influenced by the type of test conducted. CDC currently specifies a 1:5 titer (complete inhibition) by the rapid fluorescent focus inhibition test (RFFIT) as acceptable. The World Health Organization (WHO) specifies a titer of 0.5 IU.

Post-exposure Immunization

Post-exposure efficacy of Imovax Rabies vaccine was successfully proven during clinical experience in Iran in which six 1.0 mL doses were given on days 0, 3, 7, 14, 30, and 90, in conjunction with antirabies serum. Forty-five persons severely bitten by rabid dogs and wolves received Imovax Rabies vaccine within hours of and up to 14 days after the bites. All individuals were fully protected against rabies.7

Studies conducted by the United States Centers for Disease Control and Prevention (CDC) have shown that a regimen of 1 dose of Rabies Immune Globulin (RIG) and 5 doses of HDCV induced an excellent antibody response in all recipients. Of 511 persons bitten by proven rabid animals and so treated, none developed rabies.8

Do not inject Imovax Rabies vaccine in the gluteal area as there have been reports of possible vaccine failure when the vaccine has been administered in this area. Presumably, subcutaneous fat in the gluteal area may interfere with the immune response to human diploid cell rabies vaccine (HDCV).9,10

For adults and older children, Imovax Rabies vaccine should be administered in the deltoid muscle. For infants and younger children, the anterolateral aspect of the thigh is also acceptable, depending on age and body mass (see DOSAGE AND ADMINISTRATION).

REFERENCES

1 Aoki FY, Tyrell DAJ, Hill LE. Immunogenicity and acceptability of a human diploid cell culture rabies vaccine in volunteers. The Lancet. 1975 Mar 22;1(7908):660-2.

2 Cox JH, Schneider LG. Prophylactic immunization of humans against rabies by intradermal inoculation of human diploid cell culture vaccine. J Clin Microbiol. 1976 Feb;3(2):96-101.

3 Kuwert EK, Marcus I, Werner J, Iwand A, Thraenhart O. Some experiences with human diploid cell strain—(HDCS) rabies vaccine in pre- and postexposure vaccinated humans. Dev Biol Stand. 1978;40:79-88.

4 Ajjan N, Soulebot J-P, Stellmann C, Biron G, Charbonnier C, Triau R, Merieux C. Resultats de la vaccination antirabique preventive par le vaccin inactive concentre souche rabies PM/W138-1503-3M cultives sur cellules diploi'des humaines. Dev Biol Stand. 1978;40:89- 100.

5 Costy-Berger F. Vaccination antirabique preventive par du vaccin prepare sur cellules diploi'des humaines. Dev Biol Stand. 1978;40:101-4.

6 Bernard KW, Roberts MA, Sumner J, Winkler WG, Mallonee J, Baer GM, Chaney R. Human diploid cell rabies vaccine. JAMA. 1982 Feb 26;247(8):1138-42.

7 Bahmanyar M, Fayaz A, Nour-Salehi S, Mohammadi M, Koprowski H. Successful protection of humans exposed to rabies infection. JAMA. 1976 Dec 13;236(24):2751-4.

8 CDC. Recommendations of the Immunization Practices Advisory Committee (ACIP). Rabies Prevention-United States, 1984. MMWR. 1984 Jul 20;33(28):393-402, 407-8.

9 Shill M, Baynes RD, Miller SD. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. N Engl J Med. 1987 May 14;316(20):1257-58.

10 CDC. Human rabies despite treatment with rabies immune globulin and human diploid cell rabies vaccine - Thailand. MMWR. 1987 Nov 27;36(46):759-60, 765.

Last reviewed on RxList: 9/19/2014
This monograph has been modified to include the generic and brand name in many instances.

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