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Comparison of the safety and immunogenicity of ACAM1000, ACAM2000 and Dryvax in healthy vaccinia-naive adults
Authors:Sharon E. Frey  Frances K. Newman  Jeffrey S. Kennedy  Francis Ennis  Getahun Abate  Daniel F. Hoft  Thomas P. Monath
Affiliation:1. Division of Infectious Diseases and Immunology, Department of Internal Medicine, Saint Louis University School of Medicine, 1100 S. Grand Blvd - DRC-8th Floor, St. Louis, MO 63104, United States;2. Center for Infectious Disease and Vaccine Research, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, United States;3. Division of Immunobiology, Department of Internal Medicine, Saint Louis University School of Medicine, 1100 S. Grand Blvd - DRC-8th Floor, St. Louis, MO 63104, United States;4. Acambis, 38 Sidney Street, Cambridge, MA 02139, United States
Abstract:
Currently, more than half of the world's population has no immunity against smallpox variola major virus. This phase I double-blind, randomized trial was conducted to compare the safety and immunogenicity of two clonally derived, cell-culture manufactured vaccinia strains, ACAM1000 and ACAM2000, to the parent vaccine, Dryvax®. Thirty vaccinia-naïve subjects were enrolled into each of three groups and vaccines were administered percutaneously using a bifurcated needle at a dose of 1.0 × 108 PFU/mL. All subjects had a primary skin reaction indicating a successful vaccination. The adverse events, 4-fold neutralizing antibody rise and T cell immune responses were similar between the groups.
Keywords:ACAM1000   ACAM2000   Dryvax®     Cell-mediated immunity   Neutralizing antibody   Gamma-delta T cells
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