Rabies Immune Plasma Booster Study

Study Overview
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Brief Summary
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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: Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL. 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).

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

Conditions
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Rabies

Intervention / Treatment
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* Biological: Rabies Vaccine (RabAvert)
* Biological: Rabies Vaccine (Imovax)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RabAvert<br> | Biological: Rabies Vaccine (RabAvert)<br>* 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.<br>* Other names: Rabipur;|
| Imovax<br> | Biological: Rabies Vaccine (Imovax)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Reaction Rate |  | 30-35 days after each injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabies Immune Globulin, Source Plasma Donors, Booster Immunization