Rabies Immune Plasma Booster Study

Overview

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).

Full Title of Study: “Rabies Immune Plasma Booster Program – A Clinical Study Conducted as an Investigational New Drug Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2010

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • RabAvert
  • Imovax

Clinical Trial Outcome Measures

Primary 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)

Secondary Measures

  • Adverse Event Reaction Rate
    • Time Frame: 30-35 days after each injection

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • CSL Behring
  • Collaborator
    • CSL Plasma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Toby L. Simon, MD, Principal Investigator, CSL Plasma

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