Sebastian, Martin
Schröder, Andreas
Scheel, Birgit
Hong, Henoch S.
Muth, Anke
von Boehmer, Lotta
Zippelius, Alfred
Mayer, Frank
Reck, Martin
Atanackovic, Djordje
Thomas, Michael
Schneller, Folker
Stöhlmacher, Jan
Bernhard, Helga
Gröschel, Andreas
Lander, Thomas
Probst, Jochen
Strack, Tanja
Wiegand, Volker
Gnad-Vogt, Ulrike
Kallen, Karl-Josef
Hoerr, Ingmar
von der Muelbe, Florian
Fotin-Mleczek, Mariola
Knuth, Alexander
Koch, Sven D. http://orcid.org/0000-0002-6178-0448
Funding for this research was provided by:
CureVac AG
Article History
Received: 13 July 2017
Accepted: 9 February 2019
First Online: 15 February 2019
Compliance with ethical standards
:
: Martin Sebastian reports personal fees from Lilly and Roche during the conduct of the study, and personal fees from Boehringer-Ingelheim, Pfizer, Astra-Zeneca, Bristol-Myers Squibb (BMS), Merck Sharp & Dohme (MSD), and Novartis, outside the submitted work. Alfred Zippelius reports grants from Roche, Actelion, Piqur, Secarna, and Beyondsprings, and personal fees from BMS, MSD, and NBE Therapeutics outside the submitted work. Martin Reck reports personal fees from Roche, Lilly, Boehringer-Ingelheim, BMS, AstraZeneca, MSD, Novartis, Pfizer, and Celgene, outside the submitted work. Alexander Knuth reports a former scientific advisory role for CureVac AG and is co-inventor on multiple patents of Ludwig Institute for Cancer Research (LICR) related to NY-ESO-1 and MAGE, partly licensed to multiple companies including CureVac AG. Birgit Scheel, Anke Muth, Tanja Strack, Volker Wiegand, Ulrike Gnad-Vogt, Ingmar Hoerr, Florian von der Muelbe and Mariola Fotin-Mleczek are employees of CureVac AG. Thomas Lander, Andreas Schröder, Henoch S. Hong, Jochen Probst, Karl-Josef Kallen and Sven D. Koch were employees of CureVac GmbH/AG. Thomas Lander was a clinical consultant to CureVac GmbH until 2012. Thomas Lander, Jochen Probst, and Ingmar Hoerr jointly hold a patent related to the use of mRNA vaccines for treating lung cancer (WO2009/046974) filed in several jurisdictions (issued in some and pending in others). Ulrike Gnad-Vogt, Karl-Josef Kallen, and Mariola Fotin-Mleczek jointly hold a patent related to the use of mRNA vaccines for treating lung cancer (WO2015/024666) filed in several jurisdictions (still pending). All other authors declare no conflicts of interest.
: The protocol was approved by the regulatory authorities, a central ethics committee for the 12 participating centers in Germany (Ethikkommission bei der Landesärztekammer Hessen, Frankfurt am Main, Germany - Approval Number: FF 2/2009) and two local ethics committees for the two participating centers in Switzerland (Spezial-Unterkommission (SPUK) Innere Medizin, Kantonale Ethikkommission UniversitätsSpital Zürich, Zürich, Switzerland - Approval Number: EK-1639, and Ethikkommission beider Basel (EKBB), Universitätsspital Basel, Basel, Switzerland - Approval Number: 20/09). The study was conducted in accordance with Good Clinical Practice guidelines (EudraCT No.: 2008-007785-39). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent on being treated as well as on the use of generated data for research purposes and publication was obtained from all individual participants included in the study.