Rabies Immune Plasma Booster Study
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).
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Rabies
Intervention
Rabies Vaccine (RabAvert), Rabies Vaccine (Imovax)
Location
CSL Donor Plasma Center
Tempe
Arizona
United States
85282
Status
Completed
Source
CSL Behring
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01063140
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Rabies Vaccines
Vaccines or candidate vaccines used to prevent and treat RABIES. The inactivated virus vaccine is used for preexposure immunization to persons at high risk of exposure, and in conjunction with rabies immunoglobulin, for postexposure prophylaxis.
Lyssavirus
A genus of the family RHABDOVIRIDAE that includes RABIES VIRUS and other rabies-like viruses.
Rabies Virus
The type species of LYSSAVIRUS causing rabies in humans and other animals. Transmission is mostly by animal bites through saliva. The virus is neurotropic multiplying in neurons and myotubes of vertebrates.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Poliovirus Vaccine, Oral
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
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