Rabies Clinical Trial - Rabies Immune Plasma Booster Study

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Rabies

Clinical Trial Details

NCT number	NCT01063140
Study type	Observational
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 4
Start date	January 2009
Completion date	May 2010

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See also
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