VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
NCT01158157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-03-18
Summary
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
Conditions
- Smallpox Vaccine Adverse Reaction
Interventions
- BIOLOGICAL
-
ACAM2000
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
Emergent BioSolutions
lead INDUSTRY
Principal Investigators
-
Ronald Brown, MD · Cangene Plasma Resources, Mid-Florida
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-09-13
- Primary Completion
- 2012-02-14
- Completion
- 2012-02-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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