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A Multicenter, Open-Label, Controlled Phase Ii Study To Evaluate Safety And Immunogenicity Of Mva Smallpox Vaccine (Imvamune) In 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis, Richard N. Greenberg, Maria Yadira Hurley, Dinh V. Dinh, Serena Mraz, Javier Gomez Vera, Dorothea Von Bredow, Alfred Von Krempelhuber, Siegfried Roesch, Garth Virgin, Nathaly Arndtz-Wiedemann, Thomas Peter Meyer, Darja Schmidt, Richard Nichols, Philip Young, Paul Chaplin
A Multicenter, Open-Label, Controlled Phase Ii Study To Evaluate Safety And Immunogenicity Of Mva Smallpox Vaccine (Imvamune) In 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis, Richard N. Greenberg, Maria Yadira Hurley, Dinh V. Dinh, Serena Mraz, Javier Gomez Vera, Dorothea Von Bredow, Alfred Von Krempelhuber, Siegfried Roesch, Garth Virgin, Nathaly Arndtz-Wiedemann, Thomas Peter Meyer, Darja Schmidt, Richard Nichols, Philip Young, Paul Chaplin
Internal Medicine Faculty Publications
BACKGROUND: Replicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD). Prior studies evaluating Modified Vaccinia Ankara virus (MVA), a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers.
OBJECTIVE: This Phase II study compared the safety and immunogenicity of MVA enrolling groups of 350 subjects with AD (SCORAD ≤ 30) and 282 healthy subjects.
METHODS: Subjects were vaccinated twice with MVA, each dose given subcutaneously 4 weeks apart. Adverse events, cardiac parameters, and the development of vaccinia virus humoral immune responses were monitored.
RESULTS: The overall safety …