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Bayrab (Rabies Immune Globulin) - Summary

 
 



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)

Safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use in post-exposure prophylaxis. [2011.03.24]
To provide basis for human rabies vaccination in China, the safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use were assessed. A total of 250 volunteers were enrolled and divided into two groups: volunteers in Group A (n=200) were vaccinated five doses of Speeda Vero cell rabies vaccine manufactured by Liaoning Chengda Biotechnology Co.

Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults. [2010.08.16]
In the present pilot study, intradermal ID delivery systems with a BD microneedle from 1 to 3mm in length, and epidermal delivery (BD skin abrader) through abraded skin surface relative to standard intramuscular injection were evaluated. Circulating neutralizing antibodies were measured against the rabies virus after the Vero cells rabies vaccine was administered at D0, D7, D21 and D49.

Equivalence between pre-exposure schemes for human rabies and evaluation of the need for serological monitoring. [2010.06]
OBJECTIVE: To evaluate the humoral immune response to the pre-exposure schedule of human rabies vaccination through intradermal and intramuscular routes, as well as the need for serological monitoring... CONCLUSIONS: Serology after the third dose can be considered unnecessary in unexposed patients, since 97% and 100% of volunteers respectively vaccinated by the intradermal and intramuscular route presented satisfactory antibody levels (> 0.5% IU/mL).

Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine. [2010.05.28]
A chromatographically purified Vero cell rabies vaccine, Indirab manufactured by Bharat Biotech International Limited, Hyderabad, India was subjected to safety and immunogenicity studies by both intramuscular and intradermal routes of administration in parallel with a reference vaccine, Verorab... Hence it can be concluded that Indirab is as safe and immunogenic as Verorab when administered by both intramuscular and intradermal routes.

A comparative study on the safety and immunogenicity of Purified duck embryo vaccine [corrected] (PDEV, Vaxirab) with purified chick embryo cell vaccine (PCEC, Rabipur) and purifed vero cell rabies vaccine (PVRV, Verorab). [2009.12.10]
Rabies is a fatal but preventable disease...

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Clinical Trials Related to Bayrab (Rabies Immune Globulin)

Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response [Recruiting]
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.

Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins [Not yet recruiting]
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0. 5 IU/ml) for at least a year period. This study would access this subject.

Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults [Not yet recruiting]
Study design:

Single-blind (subject and observer-blinded), active-controlled, randomized [6: 2:1: 2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study

Study objectives:

Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.

Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).

Immunogenicity and Safety of Verorab� in a "One-week" Intradermal Post-exposure Prophylaxis Regimen [Recruiting]
The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.

Primary objective:

- To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal PEP

regimen (with and without rabies immunoglobulin), is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID PEP regimen with rabies immunoglobulin in terms of seroprotection rate at Day 14.

Secondary objectives:

- To describe the immune response in each group at Day 0, Day 14 and Day 90.

- To describe rabies virus-neutralizing antibody persistence during the 5 years after

completion of PEP in each group.

- To describe the immune response induced by a single-visit 4-site intradermal (ID)

booster vaccination in each group at Year 5.

- To describe the safety profile of each treatment group after the primary and booster

vaccinations.

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.

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Page last updated: 2011-12-09

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