VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Condition: Smallpox Vaccine Adverse Reaction
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Vaccination with ACAM2000
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science