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A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE.

Abstract
IMVAMUNE is a Modified Vaccinia Ankara (MVA)-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE in 164 healthy volunteers. All three IMVAMUNE doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1 x 10(8)TCID(50) IMVAMUNE dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine.
AuthorsAlfred von Krempelhuber, Jens Vollmar, Rolf Pokorny, Petra Rapp, Niels Wulff, Barbara Petzold, Amanda Handley, Lyn Mateo, Henriette Siersbol, Herwig Kollaritsch, Paul Chaplin
JournalVaccine (Vaccine) Vol. 28 Issue 5 Pg. 1209-16 (Feb 3 2010) ISSN: 1873-2518 [Electronic] Netherlands
PMID19944151 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
Copyright(c) 2009 Elsevier Ltd. All rights reserved.
Chemical References
  • Antibodies, Viral
  • Smallpox Vaccine
  • Vaccines, Attenuated
  • imvamune
Topics
  • Adult
  • Antibodies, Viral (blood, immunology)
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Safety
  • Smallpox (blood, immunology, prevention & control)
  • Smallpox Vaccine (administration & dosage, immunology)
  • Vaccines, Attenuated (administration & dosage, immunology)

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