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.

• Authors: Alfred von Krempelhuber, Jens Vollmar, Rolf Pokorny, Petra Rapp, Niels Wulff, Barbara Petzold, Amanda Handley, Lyn Mateo, Henriette Siersbol, Herwig Kollaritsch, Paul Chaplin
• Journal: Vaccine (Vaccine) Vol. 28 Issue 5 Pg. 1209-16 (Feb 03 2010) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 19944151 (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)