Rabies Immune Plasma Booster Study
Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
1 other identifier
observational
491
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedSeptember 7, 2015
September 1, 2015
1.3 years
February 4, 2010
September 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric mean titer (GMT) for rabies plasma donations received after booster injections
30-day intervals for the duration of the study (up to 2 years)
Secondary Outcomes (1)
Adverse Event Reaction Rate
30-35 days after each injection
Study Arms (2)
RabAvert
Imovax
Interventions
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.
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 Criteria
Source Plasma Donors. Donors must meet FDA and CSL Plasma requirements to be Source Plasma Donors. Donors had previously participated in CSL's rabies vaccine immunization program.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
- CSL Plasmacollaborator
Study Sites (10)
CSL Donor Plasma Center
Tempe, Arizona, 85282, United States
CSL Donor Plasma Center
Rock Island, Illinois, 61201, United States
CSL Donor Plasma Center
Oak Park, Michigan, 48237, United States
CSL Donor Plasma Center
Saint Paul, Minnesota, 55104, United States
CSL Donor Plasma Center
Cleveland, Ohio, 44109, United States
CSL Donor Plasma Center
Springfield, Ohio, 45503, United States
CSL Donor Plasma Center
Oklahoma City, Oklahoma, 73103, United States
CSL Donor Plasma Center
Medord, Oregon, 97501, United States
CSL Donor Plasma Center
Knoxville, Tennessee, 37916, United States
CSL Donor Plasma Center
Salt Lake City, Utah, 84115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toby L. Simon, MD
CSL Plasma
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Study Start
January 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
September 7, 2015
Record last verified: 2015-09