Rabies Immune Plasma Booster Study

Completed

Conditions studied: Rabies

In brief

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).

Key facts

Study ID

NCT01063140

Run by

CSL Behring

People needed

491

Starts

2009-01-01

Expected to finish

2010-05-01

Last updated by the study team

2015-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Meet requirements for Source Plasma donors
• Completed initial series of rabies antibody injections with no serious adverse events for at least 90 days prior to enrollment
• Compliance with program requirements
• Signed informed consent

You may not qualify if…

• Failure to meet requirements to be Source Plasma donor
• Non-compliance with the program
• Experience a serious adverse reaction

Where it is running

• CSL Donor Plasma Center — Tempe, Arizona, United States
• CSL Donor Plasma Center — Rock Island, Illinois, United States
• CSL Donor Plasma Center — Oak Park, Michigan, United States
• CSL Donor Plasma Center — Saint Paul, Minnesota, United States
• CSL Donor Plasma Center — Cleveland, Ohio, United States
• CSL Donor Plasma Center — Springfield, Ohio, United States
• CSL Donor Plasma Center — Oklahoma City, Oklahoma, United States
• CSL Donor Plasma Center — Medord, Oregon, United States
• CSL Donor Plasma Center — Knoxville, Tennessee, United States
• CSL Donor Plasma Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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