• Vaccine · Mar 2006

    Randomized Controlled Trial

    Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine.

    • Jens Vollmar, Nathaly Arndtz, Karl M Eckl, Torben Thomsen, Barbara Petzold, Luis Mateo, Bernd Schlereth, Amanda Handley, Lynette King, Vanessa Hülsemann, Maria Tzatzaris, Karin Merkl, Niels Wulff, and Paul Chaplin.
    • Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. jens.vollmar@bavarian-nordic.com
    • Vaccine. 2006 Mar 15; 24 (12): 2065-70.

    AbstractA 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.

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