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...
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.
|
