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Rabies Immune Plasma Booster Study

2014-08-27 03:16:08 | BioPortfolio

Summary

Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin.

The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:

1. Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.

2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis.

This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Rabies

Intervention

Rabies Vaccine (RabAvert), Rabies Vaccine (Imovax)

Location

CSL Donor Plasma Center
Tempe
Arizona
United States
85282

Status

Completed

Source

CSL Behring

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:08-0400

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