CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.
Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.
Leistungen
This deliverable will outline the procedures for risk monitoring and evaluation throughout the project and include a risk register.
Evaluation of immunogenicity of all candidates (öffnet in neuem Fenster)All vaccine candidates have been evaluated and if working, also tested for immunogenicity in mouse and rabbit studies. The samples have been analyzed.
Screening of sera from human vacinees by in vitro neutralization (öffnet in neuem Fenster)Completed analysis of human sera obtained from the vaccinated healthy volunteers in the phase I clinical trial to neutralize SARS-COV-2 in cell culture.
Interim Activity Report (öffnet in neuem Fenster)Delivery of Interim Activity report for Month 1-6
Synthesis of vaccine candidates, proteins and peptides (öffnet in neuem Fenster)All vaccine candidates, proteins and produced and delivered to KI
Results from vaccine and challenge study (öffnet in neuem Fenster)Completed analysis of protection studies in mice were immunized mice have been challenged with SARS-COV-2. This assists in the selection of the vaccine candidate.
Documentation for EMA (öffnet in neuem Fenster)Provide 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 product (öffnet in neuem Fenster)Dispensing of the vaccine candidate
QC tested and QP released GMP plasmid drug product (öffnet in neuem Fenster)QC tested and QP released GMP produced vaccine candidate
Protocol for neutralization assay (öffnet in neuem Fenster)Established assay for determination of neutralizing antibodies to SARS-COV-2 that can be used to test mouse and rabbit sera
Summarizing stability data report(s) for BDS (öffnet in neuem Fenster)Report that describes the long term stability of the vaccine candidate
Selection of the best vaccine candidate for GMP and tox studies (öffnet in neuem Fenster)One vaccine candidate has been selected based on safety and immunogenicity for production according to GMP and GLP toxicology testing.
Study plan for the GLP toxicity study (öffnet in neuem Fenster)Written plan with the design of the toxocological study of the vaccine candidate
Manufactured GMP grade bulk drug substance pDNA (öffnet in neuem Fenster)Production of a GMP grade bulk drug substance of the vaccine candidate
QC tested and QP released GMP drug substance (öffnet in neuem Fenster)Release of a GMP produced vaccine candidate
A single step delivery procedure (öffnet in neuem Fenster)Develop 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 Plan (öffnet in neuem Fenster)Establish a Communication and Dissemination Plan
Optimization of selected vaccine candidates to further avoid a cytokine storm (öffnet in neuem Fenster)ORF mutants of vaccine candidates that lost the ability to activate pro-inflammatory responses
Assays to measure cytokine induction and IFN supression (öffnet in neuem Fenster)Primers, RT-qPCR assays, transfection protocols, control constructs, transfection protocols, reporter assays
Report writing for the IMPD, month (öffnet in neuem Fenster)A written report of the toxicological evaluation of the vaccine candidate according to GLPto be submitted to EMAMPA
Midterm recruitment report (öffnet in neuem Fenster)Approvals from ethics committee and EMA/MPA for phase I clinical trial (öffnet in neuem Fenster)
Completed clinical trial in humans and writing of report (öffnet in neuem Fenster)
Summarizing stability data report(s) for plasmid drug product (öffnet in neuem Fenster)
Written reports on the stability of the GMP produced vaccine candidate
Pre-Production Evaluation and plasmid production for toxicology studies (öffnet in neuem Fenster)Complete study report on the manufacturing system performance and plasmid production for toxicological evaluation.
Consortium secured intranet and Management handbook (öffnet in neuem Fenster)These 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.
Manufactured and QP released Master Cell Bank (öffnet in neuem Fenster)Generation of a Master cell bank for the vaccine and QP release
A locked Cliniporator with pulse pattern for plasmid DNA delivery (öffnet in neuem Fenster)Establishment 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 candidates (öffnet in neuem Fenster)Statistically 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
Evaluation of the management tools and procedure (öffnet in neuem Fenster)This document will outline the outcomes of the internal evaluation of the management tools and procedures put in place in OPENCORONA including recommendations for future improvements.
Completion of the GLP toxicity study, month (öffnet in neuem Fenster)Completed toxicological evaluation according to GLP of the vaccine candidate
Optimization selected vaccine candidates to further avoid of suppression of IFN induction (öffnet in neuem Fenster)ORF mutants of vaccine candidates that lost the ability to suppress IFN induction
Challenge protocol (öffnet in neuem Fenster)Established protocol for infecting mice with SARS-COV-2 before or completed vaccinations
External Project Website launch.
Veröffentlichungen
Autoren:
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
Veröffentlicht in:
EMBO Molecular Medicine, 2022, ISSN 1757-4684
Herausgeber:
EMBO Press
DOI:
10.15252/emmm.202215821
Autoren:
Ulrike Felgenhauer, Andreas Schoen, Hans Henrik Gad, Rune Hartmann, Andreas R. Schaubmar, Klaus Failing, Christian Drosten, Friedemann Weber
Veröffentlicht in:
Journal of Biological Chemistry, Ausgabe 295/41, 2020, Seite(n) 13958-13964, ISSN 0021-9258
Herausgeber:
American Society for Biochemistry and Molecular Biology Inc.
DOI:
10.1074/jbc.ac120.013788
Autoren:
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
Veröffentlicht in:
Molecular Therapy, Ausgabe Volume 32, Ausgabe 2, 7 February 2024, 2024, Seite(n) Pages 540-555, ISSN 1525-0016
Herausgeber:
Nature Publishing Group
DOI:
10.1016/j.ymthe.2024.01.007
Autoren:
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
Veröffentlicht in:
Journal of Virology, Ausgabe 94/18, 2020, ISSN 0022-538X
Herausgeber:
American Society for Microbiology
DOI:
10.1128/jvi.01279-20
Autoren:
Natalie Frese, Patrick Schmerer, Martin Wortmann, Matthias Schürmann, Matthias König, Michael Westphal, Friedemann Weber, Holger Sudhoff, Armin Gölzhäuser
Veröffentlicht in:
Beilstein Journal of Nanotechnology, Ausgabe 12, 2021, Seite(n) 172-179, ISSN 2190-4286
Herausgeber:
Beilstein-Institut Zur Forderung der Chemischen Wissenschaften
DOI:
10.3762/bjnano.12.13
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