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NCT01063140 Clinical Trial

Rabies Immune Plasma Booster Study

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01063140
Other study ID # ZLB 1
Secondary ID
Status Completed
Phase Phase 4
First received February 4, 2010
Last updated September 3, 2015
Start date January 2009
Est. completion date May 2010

Study information
Verified date September 2015
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 491
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States CSL Donor Plasma Center Cleveland Ohio
United States CSL Donor Plasma Center Knoxville Tennessee
United States CSL Donor Plasma Center Medord Oregon
United States CSL Donor Plasma Center Oak Park Michigan
United States CSL Donor Plasma Center Oklahoma City Oklahoma
United States CSL Donor Plasma Center Rock Island Illinois
United States CSL Donor Plasma Center Salt Lake City Utah
United States CSL Donor Plasma Center Springfield Ohio
United States CSL Donor Plasma Center St. Paul Minnesota
United States CSL Donor Plasma Center Tempe Arizona

Sponsors (2)
Lead Sponsor Collaborator
CSL Behring CSL Plasma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Adverse Event Reaction Rate 30-35 days after each injection Yes
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Active, not recruiting NCT06132789 - A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10-60 Years Phase 1
Completed NCT02281396 - The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans Phase 1
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT00825305 - Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule) Phase 3
Completed NCT05547815 - Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine Phase 4
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