NCT01063140

Rabies Immune Plasma Booster Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 491 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Rabies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-02-05
• Last updated: 2015-09-07

Locations

10 sites across 1 country: United States