title: Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine.
abstract: A Phase I trial was performed to investigate the safety and immunogenicity of the third generation smallpox vaccine MVA-BN (IMVAMUNE), a highly attenuated clone derived from the Modified Vaccinia Virus Ankara strain 571, in naive and pre-immunized subjects. A total of 86 healthy subjects received the vaccine in five groups using different doses and routes of administration. All 38 subjects seroconverted in the groups receiving the highest dose (10(8) TCID50). All vaccinations were well tolerated with mainly mild or moderate pain at the injection site being the most frequent symptom. The results indicate that MVA-BN has the potential to be developed as an efficient and safe alternative to the conventional smallpox vaccines such as Lister-Elstree or Dryvax. Unique attributes render it a promising candidate for prophylactic mass immunization, even in subjects for whom conventional smallpox vaccines are contraindicated.
authors.affiliation: Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. jens.vollmar@bavarian-nordic.com
authors.forename: Jens
authors.initials: J
authors.lastname: Vollmar
authors.forename: Nathaly
authors.initials: N
authors.lastname: Arndtz
authors.forename: Karl M
authors.initials: KM
authors.lastname: Eckl
authors.forename: Torben
authors.initials: T
authors.lastname: Thomsen
authors.forename: Barbara
authors.initials: B
authors.lastname: Petzold
authors.forename: Luis
authors.initials: L
authors.lastname: Mateo
authors.forename: Bernd
authors.initials: B
authors.lastname: Schlereth
authors.forename: Amanda
authors.initials: A
authors.lastname: Handley
authors.forename: Lynette
authors.initials: L
authors.lastname: King
authors.forename: Vanessa
authors.initials: V
authors.lastname: Hülsemann
authors.forename: Maria
authors.initials: M
authors.lastname: Tzatzaris
authors.forename: Karin
authors.initials: K
authors.lastname: Merkl
authors.forename: Niels
authors.initials: N
authors.lastname: Wulff
authors.forename: Paul
authors.initials: P
authors.lastname: Chaplin
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D012449:Safety; D012899:Smallpox / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D014616:Vaccinia virus / Q000276:immunology*
chemical_list: D012900:Smallpox Vaccine