Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous(VIGIV)
This study has been completed.
Information provided by (Responsible Party):
First received: July 5, 2010
Last updated: February 28, 2012
Last verified: February 2012
The purpose of this study is to vaccinate plasma donors with ACAM2000(TM) smallpox vaccine for collection of plasma to be used in the manufacture of Vaccinia Immune Globulin Intravenous (VIGIV).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Cangene Corporation:
Primary Outcome Measures:
- Plasma collection [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]Plasma will be collected from a sufficient number of subjects vaccinated with ACAM2000 to produce approximately 60 L of plasma needed to manufacture VIGIV which will be compared to VIGIV previously collected from subjects vaccinated with Dryvax.
Secondary Outcome Measures:
- Safety [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]To collect safety data for the use of ACAM2000™ smallpox vaccine in plasma donors who have previously been vaccinated with smallpox vaccine
|Study Start Date:||August 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158157
|United States, Florida|
|Cangene Plasma Resources, Mid-Florida|
|Altamonte Springs, Florida, United States, 32701|
Sponsors and Collaborators
|Principal Investigator:||Ronald Brown, MD||Cangene Plasma Resources, Mid-Florida|