VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02443623|
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : August 18, 2021
- To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers. The collection of donor plasma will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- To ensure the safety of plasma donors vaccinated with ACAM2000 through the implementation of risk factor screening procedures and the collection of post-vaccination safety data.
|Condition or disease||Intervention/treatment||Phase|
|Smallpox Vaccine Adverse Reaction||Biological: Vaccination with ACAM2000||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3032 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2021|
|Actual Study Completion Date :||August 2021|
Experimental: Single Arm Vaccinated with ACAM2000
Biological: Vaccination with ACAM2000
In this study (VA-008), healthy adult male and female volunteers who meet the requirements for source plasma donors and study entry criteria will be vaccinated with the ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacture of VIGIV. There are possible risks associated with ACAM2000 vaccination. To ensure the safety of plasma donors, risk factor screening procedures and the collection of post-vaccination safety data will be assessed throughout the study.
- Safety as measured by the nature, date and time of onset, intensity, duration, causality, and outcome of the event post-ACAM2000 vaccination. [ Time Frame: Approximately 750 to 3000 donors will be enrolled in this study. The outcomes measures will be assessed up to 3 months post-vaccination. ]A final safety assessment at Day 90 post-vaccination. All related AEs (serious and non-serious) will be followed to resolution or stabilization as applicable (may extend beyond Day 90 post-vaccination).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443623
|Bio Products Laboratory Ltd (plasma vendor of Emergent BioSolutions)|
|Winnipeg, Manitoba, Canada, R3T 5Y3|
|Study Director:||Christine Hall, PhD||Emergent BioSolutions|