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OpenTrials
Completed

NCT Number: NCT01063140

Rabies Immune Plasma Booster 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).

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CSL Donor Plasma Center, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabies Vaccine (RabAvert)

Biological

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

Rabies Vaccine (Imovax)

Biological

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.

Primary outcomes

  1. 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 outcomes

  1. Adverse Event Reaction Rate

    Time frame: 30-35 days after each injection

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Collaborators

  • CSL Plasma

Registry information

Official study title

Rabies Immune Plasma Booster Program - A Clinical Study Conducted as an Investigational New Drug Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2010
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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