Rabies Immune Plasma Booster Study
This study has been completed.
Sponsor:
CSL Behring
Collaborator:
CSL Plasma
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT01063140
First received: February 4, 2010
Last updated: February 10, 2011
Last verified: February 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Rabies |
Biological: Rabies Vaccine (RabAvert) Biological: Rabies Vaccine (Imovax) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study |
Resource links provided by NLM:
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse Event Reaction Rate [ Time Frame: 30-35 days after each injection ] [ Designated as safety issue: Yes ]
| Enrollment: | 491 |
| Study Start Date: | January 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RabAvert |
Biological: Rabies Vaccine (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 Name: Rabipur
|
| Experimental: Imovax |
Biological: Rabies Vaccine (Imovax)
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063140
Locations
| United States, Arizona | |
| CSL Donor Plasma Center | |
| Tempe, Arizona, United States, 85282 | |
| United States, Illinois | |
| CSL Donor Plasma Center | |
| Rock Island, Illinois, United States, 61201 | |
| United States, Michigan | |
| CSL Donor Plasma Center | |
| Oak Park, Michigan, United States, 48237 | |
| United States, Minnesota | |
| CSL Donor Plasma Center | |
| St. Paul, Minnesota, United States, 55104 | |
| United States, Ohio | |
| CSL Donor Plasma Center | |
| Cleveland, Ohio, United States, 44109 | |
| CSL Donor Plasma Center | |
| Springfield, Ohio, United States, 45503 | |
| United States, Oklahoma | |
| CSL Donor Plasma Center | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| CSL Donor Plasma Center | |
| Medord, Oregon, United States, 97501 | |
| United States, Tennessee | |
| CSL Donor Plasma Center | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Utah | |
| CSL Donor Plasma Center | |
| Salt Lake City, Utah, United States, 84115 | |
Sponsors and Collaborators
CSL Behring
CSL Plasma
Investigators
| Principal Investigator: | Toby L. Simon, MD | CSL Plasma |
More Information
Additional Information:
No publications provided
| Responsible Party: | Corporate Medical Director, CSL Plasma |
| ClinicalTrials.gov Identifier: | NCT01063140 History of Changes |
| Other Study ID Numbers: | ZLB 1 |
| Study First Received: | February 4, 2010 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CSL Behring:
|
Rabies Immune Globulin Source Plasma Donors Booster Immunization |
Additional relevant MeSH terms:
|
Rabies Rhabdoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013