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Rabies Immune Plasma Booster Study

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Disease Information

Descriptive Information
Brief Title † Rabies Immune Plasma Booster Study
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: 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).
Detailed Description
Study Phase Phase 4
Study Type † Observational
Study Design † Time Perspective: Prospective
Primary Outcome Measure † Geometric mean titer (GMT) for rabies plasma donations received after booster injections
Secondary Outcome Measure † Adverse Event Reaction Rate
Condition † Rabies
Intervention † BiologicalRabies Vaccine (RabAvert)
Study Arms / Comparison Groups RabAvert Imovax
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 491
Start Date † January 2009
Completion Date May 2010
Primary Completion Date May 2010
Eligibility Criteria † Inclusion Criteria: - 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 Exclusion Criteria: - Failure to meet requirements to be Source Plasma donor - Non-compliance with the program - Experience a serious adverse reaction
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01063140
Organization ID ZLB 1
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † CSL Behring
Collaborators †† CSL Plasma
Investigators † Principal Investigator: Toby L. Simon, MD, CSL Plasma
Information Provided By
Verification Date September 2015
First Received Date † February 4, 2010
Last Updated Date September 3, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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