Deliverables
This deliverable will outline the procedures for risk monitoring and evaluation throughout the project and include a risk register.
Evaluation of immunogenicity of all candidatesAll vaccine candidates have been evaluated and if working, also tested for immunogenicity in mouse and rabbit studies. The samples have been analyzed.
Interim Activity ReportDelivery of Interim Activity report for Month 1-6
Synthesis of vaccine candidates, proteins and peptidesAll vaccine candidates, proteins and produced and delivered to KI
Documentation for EMAProvide complete documentation of the Cliniporator to the EMA/MPA for use in delivery of plasmid DNA vaccines in humans
GMP manufactured aseptically filled plasmid drug productDispensing of the vaccine candidate
Protocol for neutralization assayEstablished assay for determination of neutralizing antibodies to SARS-COV-2 that can be used to test mouse and rabbit sera
Selection of the best vaccine candidate for GMP and tox studiesOne vaccine candidate has been selected based on safety and immunogenicity for production according to GMP and GLP toxicology testing.
A single step delivery procedureDevelop a device that is added to the Cliniporation electrode handle that enables injection of DNA and in vivo electroporation in a single step. This may or may not be used in the clinical trial depending on requirements from the EMA/MPA.
Communication and Dissemination PlanEstablish a Communication and Dissemination Plan
Assays to measure cytokine induction and IFN supressionPrimers, RT-qPCR assays, transfection protocols, control constructs, transfection protocols, reporter assays
Report writing for the IMPD, monthA written report of the toxicological evaluation of the vaccine candidate according to GLPto be submitted to EMAMPA
Pre-Production Evaluation and plasmid production for toxicology studiesComplete study report on the manufacturing system performance and plasmid production for toxicological evaluation.
Consortium secured intranet and Management handbookThese tools will facilitate communication and establish the principles of work within the consortium. The Management Handbook will contain all internal consortium agreement related rules (for publication, etc.), key contact and info to use the intranet, plus a “digest” of H2020 rules easier to understand for SMEs and advices adapted to the consortium.
A locked Cliniporator with pulse pattern for plasmid DNA deliveryEstablishment of a pulse pattern for in vivo electroporation that is optimized for delivery of plasmid DNA
Assessment of cytokine induction and IFN suppression by first set of vaccine candidatesStatistically robust data on upregulation of IFN-beta, IFN-lambda 1 and 2, IL-6, IL-8, TNF-alpha, CCL4, CCL5, CXCL10. Statistically robust data on dysregulation of IFN-beta induction or IFN signaling
Completion of the GLP toxicity study, monthCompleted toxicological evaluation according to GLP of the vaccine candidate
Challenge protocolEstablished protocol for infecting mice with SARS-COV-2 before or completed vaccinations
External Project Website launch.
Publications
Author(s):
Sofia Appelberg
Gustaf Ahlén
Jingyi Yan
Negin Nikouyan
Sofie Weber
Olivia Larsson
Urban Höglund
Soo Aleman
Friedemann Weber
Emma Perlhamre
Johanna Apro
Eva-Karin Gidlund
Ola Tuvesson
Simona Salati
Matteo Cadossi
Hanna Tegel
Sophia Hober
Lars Frelin
Ali Mirazimi
Matti Sällberg
Published in:
EMBO Molecular Medicine, Issue 17574684, 2022, ISSN 1757-4684
Publisher:
EMBO Press
DOI:
10.15252/emmm.202215821
Author(s):
Ulrike Felgenhauer, Andreas Schoen, Hans Henrik Gad, Rune Hartmann, Andreas R. Schaubmar, Klaus Failing, Christian Drosten, Friedemann Weber
Published in:
Journal of Biological Chemistry, Issue 295/41, 2020, Page(s) 13958-13964, ISSN 0021-9258
Publisher:
American Society for Biochemistry and Molecular Biology Inc.
DOI:
10.1074/jbc.ac120.013788
Author(s):
Jingyi Yan
Chandrashekar Ravenna Bangalore
Negin Nikouyan
Sofia Appelberg
Daniela Nacimento Silva
Haidong Yao
Anna Pasetto
Friedemann Weber
Sofie Weber
Olivia Larsson
Urban Höglund
Gordana Bogdanovic
Malin Grabbe
Soo Aleman
Laszlo Szekely
Attila Szakos
Ola Tuvesson
Eva-Karin Gidlund
Matteo Cadossi
Simona Salati
Matti Sällberg
Published in:
Molecular Therapy, Issue Volume 32, Issue 2, 7 February 2024, 2024, Page(s) Pages 540-555, ISSN 1525-0016
Publisher:
Nature Publishing Group
DOI:
10.1016/j.ymthe.2024.01.007
Author(s):
Gustaf Ahlén, Lars Frelin, Negin Nikouyan, Friedemann Weber, Urban Höglund, Olivia Larsson, Marie Westman, Ola Tuvesson, Eva-karin Gidlund, Matteo Cadossi, Sofia Appelberg, Ali Mirazimi, Matti Sällberg
Published in:
Journal of Virology, Issue 94/18, 2020, ISSN 0022-538X
Publisher:
American Society for Microbiology
DOI:
10.1128/jvi.01279-20
Author(s):
Natalie Frese, Patrick Schmerer, Martin Wortmann, Matthias Schürmann, Matthias König, Michael Westphal, Friedemann Weber, Holger Sudhoff, Armin Gölzhäuser
Published in:
Beilstein Journal of Nanotechnology, Issue 12, 2021, Page(s) 172-179, ISSN 2190-4286
Publisher:
Beilstein-Institut Zur Forderung der Chemischen Wissenschaften
DOI:
10.3762/bjnano.12.13
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