Rabies Immune Plasma Booster Study

Completed

• Conditions: Rabies
• Interventions: Biological: Rabies Vaccine (RabAvert); Biological: Rabies Vaccine (Imovax)

• Registration Number: NCT01063140
• Lead Sponsor: CSL Behring

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

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Exclusion Criteria

• Failure to meet requirements to be Source Plasma donor
• Non-compliance with the program
• Experience a serious adverse reaction

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RabAvert	Rabies Vaccine (RabAvert)	-
Imovax	Rabies Vaccine (Imovax)	-

Primary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) for rabies plasma donations received after booster injections	30-day intervals for the duration of the study (up to 2 years)

Secondary Outcome Measures

Name	Time	Method
Adverse Event Reaction Rate	30-35 days after each injection

Trial Locations

Locations (1)

CSL Donor Plasma Center; 🇺🇸 Salt Lake City, Utah, United States