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

February 4, 2010
February 10, 2011
January 2009
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01063140 on ClinicalTrials.gov Archive Site
Adverse Event Reaction Rate [ Time Frame: 30-35 days after each injection ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Rabies Immune Plasma Booster Study
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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Rabies
  • 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
  • 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.
  • Experimental: RabAvert
    Intervention: Biological: Rabies Vaccine (RabAvert)
  • Experimental: Imovax
    Intervention: Biological: Rabies Vaccine (Imovax)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
491
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01063140
ZLB 1
Not Provided
Corporate Medical Director, CSL Plasma
CSL Behring
CSL Plasma
Principal Investigator: Toby L. Simon, MD CSL Plasma
CSL Behring
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP