Clinical Trial: Rabies Immune Plasma Booster Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
Brief 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:
- Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.
- 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).
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Geometric mean titer (GMT) for rabies plasma donations received after booster injections [ Time Frame: 30-day intervals for the duration of the study (up to 2 years) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Adverse Event Reaction Rate [ Time Frame: 30-35 days after each injection ]
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: February 4, 2010
Date Started: January 2009
Date Completion:
Last Updated: September 3, 2015
Last Verified: September 2015
