BAYRAB SUMMARY
Rabies Immune Globulin (Human) -- BayRab® treated with solvent/detergent is a sterile solution of antirabies immune globulin for intramuscular administration; it contains no preservative. BayRab is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayRab is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayRab is then incubated in the final container for 21-28 days at 20-27°C. The product is standardized against the U.S. Standard
Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody.
Rabies vaccine and BayRab should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. BayRab should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.
Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP).19
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NEWS HIGHLIGHTS
Published Studies Related to Bayrab (Rabies Immune Globulin)
A three-year clinical study on immunogenicity, safety, and booster response of purified chick embryo cell rabies vaccine administered intramuscularly or intradermally to 12- to 18-month-old Thai children, concomitantly with Japanese encephalitis vaccine. [2009.04]
After concomitant administration of purified chick embryo cell rabies vaccine and Japanese encephalitis vaccine to toddlers, adequate rabies and Japanese encephalitis virus neutralizing antibodies concentrations were demonstrated by day 49, 7 days after a booster at 1 year, and in the majorly at 3 years postvaccination.
Comparison of antibody responses after vaccination with two inactivated rabies vaccines. [2009.01.13]
Thirty laboratory dogs were randomly assigned to two groups (A and B) of 15 dogs and subcutaneously vaccinated with a single dose of one of two commercially available monovalent inactivated rabies vaccines: RABISIN (Merial, France) (group A) and NOBIVAC Rabies (Intervet International) (group B)...
Efficiency of Matricaria chamomilla CH12 and number of doses of rabies vaccine on the humoral immune response in cattle. [2008.12]
This study evaluated the effect of Matricaria chamomilla and vaccination frequency on cattle immunization against rabies. Four groups (n = 15 /group) were treated with or without Matricaria chamomilla CH12 and vaccinated with one or two doses of rabies vaccine (30 day interval)... In conclusion, the use of chamomile did not alter the humoral immune response in cattle, and two vaccine doses are suggested for achieving protective antibody titers.
First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity. [2008.11.05]
Immediate passive immune prophylaxis as part of rabies post-exposure prophylaxis (PEP) often cannot be provided due to limited availability of human or equine rabies immunoglobulin (HRIG and ERIG, respectively). We report first clinical data from two phase I studies evaluating a monoclonal antibody cocktail CL184 against rabies.
Protecting Indian schoolchildren against rabies: pre-exposure vaccination with purified chick embryo cell vaccine (PCECV) or purified verocell rabies vaccine (PVRV). [2008.09]
Although rabies can be effectively prevented by means of preexposure or post-exposure prophylaxis, in India, an estimated 17,000 to 20,000 human rabies deaths occur annually.A 1.0 mL dilution volume for PCECV was as well tolerated as PVRV or PCECV reconstituted in half the volume.
Clinical Trials Related to Bayrab (Rabies Immune Globulin)
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents [Recruiting]
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in
combination with rabies vaccine compared with human rabies immune globulin (HRIG) in
combination with rabies vaccine in healthy children and adolescents.
A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects [Recruiting]
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in
combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo
in combination with rabies vaccine in healthy adult subjects.
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Page last updated: 2009-10-20
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