Clinical Trial: VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)

Brief 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 Summary:

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.

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).