Clinical trial NCT01063140: Rabies Immune Plasma Booster Study
Official title: Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rabies
Keywords: Rabies Immune Globulin
Source Plasma Donors
Booster Immunization
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
Collaborators: name: CSL Plasma
First posted: 2010-02-05
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


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

Primary outcomes:
measure: Geometric mean titer (GMT) for rabies plasma donations received after booster injections
timeFrame: 30-day intervals for the duration of the study (up to 2 years)
Secondary outcomes:
measure: Adverse Event Reaction Rate
timeFrame: 30-35 days after each injection
Other outcomes:
Locations:
city: Tempe
country: United States
facility: CSL Donor Plasma Center
state: Arizona
city: Rock Island
country: United States
facility: CSL Donor Plasma Center
state: Illinois
city: Oak Park
country: United States
facility: CSL Donor Plasma Center
state: Michigan
city: St. Paul
country: United States
facility: CSL Donor Plasma Center
state: Minnesota
city: Cleveland
country: United States
facility: CSL Donor Plasma Center
state: Ohio
city: Springfield
country: United States
facility: CSL Donor Plasma Center
state: Ohio
city: Oklahoma City
country: United States
facility: CSL Donor Plasma Center
state: Oklahoma
city: Medord
country: United States
facility: CSL Donor Plasma Center
state: Oregon
city: Knoxville
country: United States
facility: CSL Donor Plasma Center
state: Tennessee
city: Salt Lake City
country: United States
facility: CSL Donor Plasma Center
state: Utah
Study officials:
affiliation: CSL Plasma
name: Toby L. Simon, MD
role: PRINCIPAL_INVESTIGATOR
References: