Rabies Immune Plasma Booster Study

This study has been completed.

Sponsor:

Collaborator:

CSL Plasma

Information provided by:

CSL Behring

ClinicalTrials.gov Identifier:

NCT01063140

First received: February 4, 2010

Last updated: February 10, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 4, 2010

Last Updated Date

February 10, 2011

Start Date ^ICMJE

January 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Geometric mean titer (GMT) for rabies plasma donations received after booster injections [ Time Frame: 30-day intervals for the duration of the study (up to 2 years) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01063140 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse Event Reaction Rate [ Time Frame: 30-35 days after each injection ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rabies Immune Plasma Booster Study

Official Title ^ICMJE

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

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:

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Rabies

Intervention ^ICMJE

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.

Other Name: Rabipur
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.

Study Arm (s)

Experimental: RabAvert
Intervention: Biological: Rabies Vaccine (RabAvert)
Experimental: Imovax
Intervention: Biological: Rabies Vaccine (Imovax)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

491

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01063140

Other Study ID Numbers ^ICMJE

ZLB 1

Has Data Monitoring Committee

Not Provided

Responsible Party

Corporate Medical Director, CSL Plasma

Study Sponsor ^ICMJE

CSL Behring

Collaborators ^ICMJE

CSL Plasma

Investigators ^ICMJE

Principal Investigator:

Toby L. Simon, MD

CSL Plasma

Information Provided By

CSL Behring

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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