Rabies Immune Plasma Booster Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01063140

Enrollment

491

Registered

2010-02-05

Start date

2009-01-31

Completion date

2010-05-31

Last updated

2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

Rabies Immune Globulin, Source Plasma Donors, Booster Immunization

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).

Interventions

BIOLOGICALRabies 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.

BIOLOGICALRabies Vaccine (Imovax)

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Adverse Event Reaction Rate	30-35 days after each injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026