title: 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.
abstract: 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 of the vaccine was similar in both groups. Adverse events affecting skin were experienced significantly more often in subjects with AD, but the majority of these events were mild to moderate in intensity. Seroconversion rates and geometric mean titers for total and neutralizing vaccinia-specific antibodies in the AD group were non-inferior compared to the healthy subjects.
  
  
  CONCLUSIONS
  The size of the study population limited the detection of serious adverse events occurring at a frequency less than 1%.
  
  
  CONCLUSIONS
  MVA has a favorable safety profile and the ability to elicit vaccinia-specific immune responses in subjects with AD.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00316602.
authors.affiliation: University of Kentucky School of Medicine, Lexington, KY, United States of America.
authors.forename: Richard N
authors.initials: RN
authors.lastname: Greenberg
authors.forename: Maria Yadira
authors.initials: MY
authors.lastname: Hurley
authors.affiliation: Saint Louis University, Department of Dermatology, Saint Louis, MO, United States of America.
authors.forename: Yadira
authors.initials: Y
authors.lastname: Hurley
authors.affiliation: Rx Clinical Research, Inc., Garden Grove, CA, United States of America.
authors.forename: Dinh V
authors.initials: DV
authors.lastname: Dinh
authors.affiliation: Vallejo Dermatology Office, Vallejo, CA, United States of America.
authors.forename: Serena
authors.initials: S
authors.lastname: Mraz
authors.affiliation: Hospital Regional Lic. Adolfo Lopez Mateos, ISSSTE, Mexico City, Mexico.
authors.forename: Javier Gomez
authors.initials: JG
authors.lastname: Vera
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Dorothea
authors.initials: D
authors.lastname: von Bredow
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Alfred
authors.initials: A
authors.lastname: von Krempelhuber
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Roesch
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Garth
authors.initials: G
authors.lastname: Virgin
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Nathaly
authors.initials: N
authors.lastname: Arndtz-Wiedemann
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Thomas Peter
authors.initials: TP
authors.lastname: Meyer
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Darja
authors.initials: D
authors.lastname: Schmidt
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Richard
authors.initials: R
authors.lastname: Nichols
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Philip
authors.initials: P
authors.lastname: Young
authors.affiliation: Bavarian Nordic GmbH, Martinsried, Germany.
authors.forename: Paul
authors.initials: P
authors.lastname: Chaplin
mesh_terms: D000293:Adolescent; D000328:Adult; D000917:Antibody Formation / Q000276:immunology; D003876:Dermatitis, Atopic / Q000276:immunology* / Q000517:prevention & control*; D006801:Humans; D012900:Smallpox Vaccine / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use; D014611:Vaccination; D014616:Vaccinia virus / Q000276:immunology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D012900:Smallpox Vaccine; D014765:Viral Vaccines