Rabies Immune Plasma Booster Study

This study has been completed.
Sponsor:
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
  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:

  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).


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014