drugset / Trial / NCT02443623

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

NCT02443623

Phase 4 Completed 3032 enrolled Emergent BioSolutions
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2015-09
Primary completion
2021-07
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ACAM2000 Vaccine

Indications