Literature DB >> 19944151

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

Alfred von Krempelhuber1, Jens Vollmar, Rolf Pokorny, Petra Rapp, Niels Wulff, Barbara Petzold, Amanda Handley, Lyn Mateo, Henriette Siersbol, Herwig Kollaritsch, Paul Chaplin.   

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. (c) 2009 Elsevier Ltd. All rights reserved.

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Year:  2009        PMID： 19944151      PMCID： PMC2814951          DOI： 10.1016/j.vaccine.2009.11.030

Source DB:  PubMed          Journal:  Vaccine        ISSN： 0264-410X            Impact factor:   3.641


  35 in total

1.  IMVAMUNE, an attenuated modified vaccinia Ankara virus vaccine for smallpox infection.

Authors:  Taff Jones
Journal:  Curr Opin Mol Ther       Date:  2008-08

2.  Short-term, but not post-exposure, protection against lethal orthopoxvirus challenge after immunization with modified vaccinia virus Ankara.

Authors:  Caroline Staib; Yasemin Suezer; Sigrid Kisling; Ulrich Kalinke; Gerd Sutter
Journal:  J Gen Virol       Date:  2006-10       Impact factor: 3.891

3.  Rapid protection in a monkeypox model by a single injection of a replication-deficient vaccinia virus.

Authors:  Patricia L Earl; Jeffrey L Americo; Linda S Wyatt; Ondraya Espenshade; Jocelyn Bassler; Kathy Gong; Shuling Lin; Elizabeth Peters; Lowrey Rhodes; Yvette Edghill Spano; Peter M Silvera; Bernard Moss
Journal:  Proc Natl Acad Sci U S A       Date:  2008-08-04       Impact factor: 11.205

4.  Induction of natural killer cell responses by ectromelia virus controls infection.

Authors:  April Keim Parker; Scott Parker; Wayne M Yokoyama; John A Corbett; R Mark L Buller
Journal:  J Virol       Date:  2007-02-07       Impact factor: 5.103

Review 5.  IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine.

Authors:  Jeffrey S Kennedy; Richard N Greenberg
Journal:  Expert Rev Vaccines       Date:  2009-01       Impact factor: 5.217

6.  Genomic sequence of chorioallantois vaccinia virus Ankara, the ancestor of modified vaccinia virus Ankara.

Authors:  Christine Meisinger-Henschel; Michaela Schmidt; Susanne Lukassen; Burkhard Linke; Lutz Krause; Sebastian Konietzny; Alexander Goesmann; Paul Howley; Paul Chaplin; Mark Suter; Jürgen Hausmann
Journal:  J Gen Virol       Date:  2007-12       Impact factor: 3.891

7.  Clinical and immunologic responses to multiple doses of IMVAMUNE (Modified Vaccinia Ankara) followed by Dryvax challenge.

Authors:  Sharon E Frey; Frances K Newman; Jeffrey S Kennedy; Vera Sobek; Francis A Ennis; Heather Hill; Lihan K Yan; Paul Chaplin; Jens Vollmar; Bernard R Chaitman; Robert B Belshe
Journal:  Vaccine       Date:  2007-10-26       Impact factor: 3.641

8.  Electrocardiography screening for cardiotoxicity after modified Vaccinia Ankara vaccination.

Authors:  Junko Sano; Bernard R Chaitman; Jason Swindle; Sharon E Frey
Journal:  Am J Med       Date:  2009-01       Impact factor: 4.965

9.  Survival of lethal poxvirus infection in mice depends on TLR9, and therapeutic vaccination provides protection.

Authors:  Christofer Samuelsson; Jürgen Hausmann; Henning Lauterbach; Michaela Schmidt; Shizuo Akira; Hermann Wagner; Paul Chaplin; Mark Suter; Meredith O'Keeffe; Hubertus Hochrein
Journal:  J Clin Invest       Date:  2008-05       Impact factor: 14.808

10.  Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial.

Authors:  Jorma Paavonen; David Jenkins; F Xavier Bosch; Paulo Naud; Jorge Salmerón; Cosette M Wheeler; Song-Nan Chow; Dan L Apter; Henry C Kitchener; Xavier Castellsague; Newton S de Carvalho; S Rachel Skinner; Diane M Harper; James A Hedrick; Unnop Jaisamrarn; Genara Am Limson; Marc Dionne; Wim Quint; Bart Spiessens; Pascal Peeters; Frank Struyf; Susan L Wieting; Matti O Lehtinen; Gary Dubin
Journal:  Lancet       Date:  2007-06-30       Impact factor: 79.321
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  48 in total

1.  Immediate-early expression of a recombinant antigen by modified vaccinia virus ankara breaks the immunodominance of strong vector-specific B8R antigen in acute and memory CD8 T-cell responses.

Authors:  Karen Baur; Kay Brinkmann; Marc Schweneker; Juliane Pätzold; Christine Meisinger-Henschel; Judith Hermann; Robin Steigerwald; Paul Chaplin; Mark Suter; Jürgen Hausmann
Journal:  J Virol       Date:  2010-06-10       Impact factor: 5.103

2.  Multivalent smallpox DNA vaccine delivered by intradermal electroporation drives protective immunity in nonhuman primates against lethal monkeypox challenge.

Authors:  Lauren A Hirao; Ruxandra Draghia-Akli; Jonathan T Prigge; Maria Yang; Abhishek Satishchandran; Ling Wu; Erika Hammarlund; Amir S Khan; Tahar Babas; Lowrey Rhodes; Peter Silvera; Mark Slifka; Niranjan Y Sardesai; David B Weiner
Journal:  J Infect Dis       Date:  2011-01-01       Impact factor: 5.226

3.  Sex difference in immune response to vaccination: A participant-level meta-analysis of randomized trials of IMVAMUNE smallpox vaccine.

Authors:  Jesse D Troy; Heather R Hill; Marian G Ewell; Sharon E Frey
Journal:  Vaccine       Date:  2015-08-28       Impact factor: 3.641

4.  Mutations conferring resistance to viral DNA polymerase inhibitors in camelpox virus give different drug-susceptibility profiles in vaccinia virus.

Authors:  Sophie Duraffour; Graciela Andrei; Dimitri Topalis; Marcela Krečmerová; Jean-Marc Crance; Daniel Garin; Robert Snoeck
Journal:  J Virol       Date:  2012-04-24       Impact factor: 5.103

5.  Assessment of the protective effect of Imvamune and Acam2000 vaccines against aerosolized monkeypox virus in cynomolgus macaques.

Authors:  Graham J Hatch; Victoria A Graham; Kevin R Bewley; Julia A Tree; Mike Dennis; Irene Taylor; Simon G P Funnell; Simon R Bate; Kimberley Steeds; Thomas Tipton; Thomas Bean; Laura Hudson; Deborah J Atkinson; Gemma McLuckie; Melanie Charlwood; Allen D G Roberts; Julia Vipond
Journal:  J Virol       Date:  2013-05-08       Impact factor: 5.103

6.  Phase II randomized, double-blinded comparison of a single high dose (5×10(8) TCID50) of modified vaccinia Ankara compared to a standard dose (1×10(8) TCID50) in healthy vaccinia-naïve individuals.

Authors:  Sharon E Frey; Patricia L Winokur; Heather Hill; Johannes B Goll; Paul Chaplin; Robert B Belshe
Journal:  Vaccine       Date:  2014-03-06       Impact factor: 3.641

7.  DNA and modified vaccinia virus Ankara vaccines encoding multiple cytotoxic and helper T-lymphocyte epitopes of human immunodeficiency virus type 1 (HIV-1) are safe but weakly immunogenic in HIV-1-uninfected, vaccinia virus-naive adults.

Authors:  Geoffrey J Gorse; Mark J Newman; Allan deCamp; Christine Mhorag Hay; Stephen C De Rosa; Elizabeth Noonan; Brian D Livingston; Jonathan D Fuchs; Spyros A Kalams; Farah L Cassis-Ghavami
Journal:  Clin Vaccine Immunol       Date:  2012-03-07

8.  Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects.

Authors:  Richard N Greenberg; Edgar Turner Overton; David W Haas; Ian Frank; Mitchell Goldman; Alfred von Krempelhuber; Garth Virgin; Nicole Bädeker; Jens Vollmar; Paul Chaplin
Journal:  J Infect Dis       Date:  2012-12-07       Impact factor: 5.226

9.  Safety and immunogenicity of modified vaccinia Ankara in hematopoietic stem cell transplant recipients: a randomized, controlled trial.

Authors:  Stephen R Walsh; Marissa B Wilck; David J Dominguez; Elise Zablowsky; Shringkhala Bajimaya; Lisa S Gagne; Kelly A Verrill; Jane A Kleinjan; Alka Patel; Ying Zhang; Heather Hill; Aruna Acharyya; David C Fisher; Joseph H Antin; Michael S Seaman; Raphael Dolin; Lindsey R Baden
Journal:  J Infect Dis       Date:  2013-03-12       Impact factor: 5.226

10.  Safety of attenuated smallpox vaccine LC16m8 in immunodeficient mice.

Authors:  Hiroyuki Yokote; Yasuhiko Shinmura; Tomomi Kanehara; Shinichi Maruno; Masahiko Kuranaga; Hajime Matsui; So Hashizume
Journal:  Clin Vaccine Immunol       Date:  2014-07-02
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