Objectives: * 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.
This protocol is being conducted 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). The objective of this protocol is 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. Participants will be followed for the duration of the study, an expected average of 90 days as described below in the planned study assessments. Screening \[complete within 14 days before Baseline (Day 0)\]: * Informed consent obtained from prospective donors * Post-consent information including medical history, smallpox vaccination history, current medications, detailed demographics, BMI, physical exam, vital signs, and assessment for pericarditis/myocarditis symptoms, blood samples will be collected and a baseline EKG (if applicable). Baseline (Day 0) prior to vaccination: -Physical exam and vital signs, urine pregnancy test for all female subjects of child-bearing potential, current medications, assessment for pericarditis/myocarditis. Baseline (Day 0) vaccination and post-vaccination: -Vaccination with ACAM2000, vaccination site inspection 30 post-vaccination, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications. Post-vaccination Day 3 (±1): -Assessment for pericarditis/myocarditis, vaccination site inspection, unanticipated problems, unexpected and serious adverse reactions or complications post-vaccination, all adverse events including all cardiovascular adverse events (symptoms and signs). Post-vaccination Day 7 (±1): -Assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications. Post-vaccination Day 12 (±2), 21 (±3), and 28 (±3): -Assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications. End of study post-vaccination Day 35 (±3) or Early Withdrawal: Vital signs, assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications. Final Safety Assessment Day 90 (±3): Assessment for pericarditis/myocarditis, unanticipated problems, unexpected and serious adverse reactions or complications post-vaccination, all adverse events including all cardiovascular adverse events (symptoms and signs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
3,032
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.
Bio Products Laboratory Ltd (plasma vendor of Emergent BioSolutions)
Winnipeg, Manitoba, Canada
Number of Vaccinated Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs)
Number of subjects with AEs including SAEs up to 90 days after vaccination.
Time frame: Adverse event data was collected from vaccinated participants through Day 90.
Number of Vaccinated Participants With Related Adverse Events
Number of subjects with related AEs up to 90 days after vaccination.
Time frame: Adverse event data was collected from vaccinated participants through Day 90.
Number of Vaccinated Participants With Serious Adverse Events (SAEs)
Number of subjects with SAEs up to 90 days after vaccination.
Time frame: Adverse event data was collected from vaccinated participants through Day 90.
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