- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063140
Rabies Immune Plasma Booster Study
Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Arizona
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Tempe, Arizona, United States, 85282
- CSL Donor Plasma Center
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Illinois
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Rock Island, Illinois, United States, 61201
- CSL Donor Plasma Center
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Michigan
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Oak Park, Michigan, United States, 48237
- CSL Donor Plasma Center
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Minnesota
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St. Paul, Minnesota, United States, 55104
- CSL Donor Plasma Center
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Ohio
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Cleveland, Ohio, United States, 44109
- CSL Donor Plasma Center
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Springfield, Ohio, United States, 45503
- CSL Donor Plasma Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- CSL Donor Plasma Center
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Oregon
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Medord, Oregon, United States, 97501
- CSL Donor Plasma Center
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Tennessee
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Knoxville, Tennessee, United States, 37916
- CSL Donor Plasma Center
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Utah
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Salt Lake City, Utah, United States, 84115
- CSL Donor Plasma Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RabAvert
|
The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL.
A maximum of 4 booster immunizations may be administered over the 2 year study period.
Other Names:
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Imovax
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The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL.
A maximum of 4 booster immunizations may be administered over the 2 year study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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30-day intervals for the duration of the study (up to 2 years)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Event Reaction Rate
Time Frame: 30-35 days after each injection
|
30-35 days after each injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Toby L. Simon, MD, CSL Plasma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZLB 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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