A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE.
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.
von Krempelhuber
Alfred
A
Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany. alfred.krempelhuber@bavarian-nordic.com
Vollmar
Jens
J
Pokorny
Rolf
R
Rapp
Petra
P
Wulff
Niels
N
Petzold
Barbara
B
Handley
Amanda
A
Mateo
Lyn
L
Siersbol
Henriette
H
Kollaritsch
Herwig
H
Chaplin
Paul
P
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012449:Safety; D012899:Smallpox / Q000097:blood / Q000276:immunology / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000008:administration & dosage* / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology
D000914:Antibodies, Viral; D012900:Smallpox Vaccine; D014613:Vaccines, Attenuated; C527606:smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic