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High titer antibody responses of the Sanofi Pasteur SA 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, Sanofi Pasteur SA 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.
Postexposure efficacy of Sanofi Pasteur SA Imovax Rabies Vaccine was successfully proven during clinical experience in Iran7 in conjunction with antirabies serum. Forty-five persons severely bitten by rabid dogs and wolves received Sanofi vaccine within hours of and up to 14 days after the bites. All individuals were fully protected against rabies.
There have been reports of possible vaccine failure when the vaccine has been administered in the gluteal area. Presumably subcutaneous fat in the gluteal area may interfere with the immunogenicity of human diploid cell rabies vaccine (HDCV).26, 29 For adults and children, Rabies Vaccine should be administered in the deltoid muscle. (See DOSAGE AND ADMINISTRATION.)
1. Aoki FY, Tyrell DAJ, Hill LE. Immunogenicity and acceptability of a human diploid cell culture rabies vaccine in volunteers. The Lancet, March 22, pp. 660-2 (1975).
2. Cox JH, Schneider LG. Prophylactic immunization of humans against rabies by intradermal inoculation of human diploid cell culture vaccine. J Clin Microbiol 3: 96-101 (1976).
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. Develop Biol Standard 40: 79-88 (1978).
4. Ajjan N, Soulebot J-P, Stellmann C, Biron G, Charbonnier C, Triau R, Mérieux C. Résultats de la vaccination antirabique préventive par le vaccin inactivé concentré souche rabies PM/W138-1503-3M cultivés sur cellules diploïdes humaines. Develop Biol Standard 40:89-199 (1978).
5. Costy-Berger F. Vaccination antirabique préventive par du vaccin préparé sur cellules diploïdes humaines. Develop Biol Standard 40:101-4 (1978).
6. Bernard KW, Roberts MA, Sumner J, Winkler WG, Mallonee J, Baer GM, Chaney R. Human diploid cell rabies vaccine JAMA 247:1138-42 (1982).
7. Bahmanyar M, Fayaz A, Nour-Salehi S, Mohammadi M, Koprowski H. Successful protection of humans exposed to rabies infection. JAMA 236: 2751-4 (1976).
26. Shill M, Baynes RD, Miller SD. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. N Engl J Med 316: 1257-58 (1987).
29. CDC. Human rabies despite treatment with Rabies Immune Globulin and Human Diploid Cell Rabies Vaccine - Thailand. MMWR 36: 759-765 (1987).
Last reviewed on RxList: 11/10/2008
This monograph has been modified to include the generic and brand name in many instances.
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