Rabies Immune Plasma Booster Study

September 3, 2015 updated by: CSL Behring

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:

  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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

491

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • CSL Donor Plasma Center
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • CSL Donor Plasma Center
    • Michigan
      • Oak Park, Michigan, United States, 48237
        • CSL Donor Plasma Center
    • Minnesota
      • St. Paul, Minnesota, United States, 55104
        • CSL Donor Plasma Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • CSL Donor Plasma Center
      • Springfield, Ohio, United States, 45503
        • CSL Donor Plasma Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • CSL Donor Plasma Center
    • Oregon
      • Medord, Oregon, United States, 97501
        • CSL Donor Plasma Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • CSL Donor Plasma Center
    • Utah
      • Salt Lake City, Utah, United States, 84115
        • CSL Donor Plasma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Rabipur
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.

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)
30-day intervals for the duration of the study (up to 2 years)

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

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Collaborators

CSL Plasma

Investigators

  • Principal Investigator: Toby L. Simon, MD, CSL Plasma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

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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