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BayRab

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BayRab

CLINICAL PHARMACOLOGY

The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran.1,2 Similarly, beneficial results were later reported from the U.S.S.R.3 Studies coordinated by WHO helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man.4-7 These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series.

Preparation of rabies immune globulin of human origin with adequate potency was reported by Cabasso et al.8 In carefully controlled clinical studies, this globulin was used in conjunction with rabies vaccine of duck-embryo origin (DEV).8,9 These studies determined that a human globulin dose of 20 IU/kg of rabies antibody, given simultaneously with the first DEV dose, resulted in amply detectable levels of passive rabies antibody 24 hours after injection in all recipients. The injections produced minimal, if any, interference with the subject's endogenous antibody response to DEV.

More recently, human diploid cell rabies vaccines (HDCV) prepared from tissue culture fluids containing rabies virus have received substantial clinical evaluation in Europe and the United States.10-16 In a study in adult volunteers, the administration of Rabies Immune Globulin (Human) did not interfere with antibody formation induced by HDCV when given in a dose of 20 IU per kilogram body weight simultaneously with the first dose of vaccine.15

In a clinical study in eight healthy human adults receiving a 20 IU/kg intramuscular dose of Rabies Immune Globulin (Human) treated with solvent/detergent, BayRab® (rabies immune globulin (human) solvent/detergent treated) , detectable passive rabies antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results are consistent with prior studies 17,18 with non-solvent/detergent treated product.

REFERENCES

1. Baltazard M, Bahmanyar M, Ghodssi M, et al: Essai pratique du sérum antirabique chez les mordus par loups enragés. Bull WHO 13:747-72, 1955.

2. Habel K, Koprowski H: Laboratory data supporting the clinical trial of antirabies serum in persons bitten by a rabid wolf. Bull WHO 13:773-9, 1955.

3. Selimov M, Boltucij L, Semenova E, et al: [The use of antirabies gamma globulin in subjects severely bitten by rabid wolves or other animals.] J Hyg Epidemiol Microbiol Immunol (Praha) 3:168-80, 1959.

4. Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons. Bull WHO 14:593-611, 1956.

5. Atanasiu P, Bahmanyar M, Baltazard M, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part II. Bull WHO 17:911-32, 1957.

6. Atanasiu P, Cannon DA, Dean DJ, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine innoculations in non-exposed persons: Part 3. Bull WHO 25:103-14, 1961.

7. Atanasiu P, Dean DJ, Habel K, et al: Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons: Part 4. Bull WHO 36:361-5, 1967.

8. Cabasso VJ, Loofbourow JC, Roby RE, et al: Rabies immune globulin of human origin: preparation and dosage determination in non-exposed vol-unteer subjects. Bull WHO 45:303-15, 1971.

9. Loofbourow JC, Cabasso VJ, Roby RE, et al: Rabies immune globulin (human): clinical trials and dose determination. JAMA 217(13): 1825-31, 1971.

10. Plotkin SA: New rabies vaccine halts disease — without severe reactions. Mod Med 45(20):45-8, 1977.

11. Plotkin SA, Wiktor TJ, Koprowski H, et al: Immunization schedules for the new human diploid cell vaccine against rabies. Am J Epidemiol 103(1):75-80, 1976.

12. Hafkin B, Hattwick MA, Smith JS, et al: A comparison of a WI-38 vaccine and duck embryo vaccine for preexposure rabies prophylaxis. Am J Epidemiol 107(5):439-43, 1978.

13. Kuwert EK, Marcus I, Höher PG: Neutralizing and complement-fixing antibody responses in pre- and postexposure vaccinees to a rabies vaccine produced in human diploid cells. J Biol Stand 4(4):249-62, 1976.

14. Grandien M: Evaluation of tests for rabies antibody and analysis of serum responses after administration of three different types of rabies vac-cines. J Clin Microbiol 5(3):263-7, 1977.

15. Kuwert EK, Marcus I, Werner J, et al: Postexpositionelle Schutzimpfung des Menschen gegen Tollwut mit einer neu-entwickelten Gewebekulturvakzine (HDCS-Impfstoff). Zentralbl Bakteriol [A] 239(4):437-58, 1977.

16. Bahmanyar M, Fayaz A, Nour-Salehi S, et al: Successful protection of humans exposed to rabies infection: postexposure treatment with the new human diploid cell rabies vaccine and antirabies serum. JAMA 236(24):2751-4, 1976.

17. American Hospital Formulary Service. Drug Information. Section 80:04. Rabies immune globulin. Bethesda, American Society for Health-Systems Pharmacy, 1997, p. 2545-7.

18. Rubin Rh, Sikes RK, Gregg MB: Human rabies immune globulin. Clinical trials and effects on serum antiglobulins. JAMA 224:871-4, 1973.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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