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Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.

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

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1
Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. alfred.krempelhuber@bavarian-nordic.com

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.

PMID:
19944151
PMCID:
PMC2814951
DOI:
10.1016/j.vaccine.2009.11.030
[Indexed for MEDLINE]
Free PMC Article
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