CORDIS provides links to public deliverables and publications of HORIZON projects.
Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .
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 candidates (opens in new window)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 (opens in new window)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 (opens in new window)Delivery of Interim Activity report for Month 1-6
Synthesis of vaccine candidates, proteins and peptides (opens in new window)All vaccine candidates, proteins and produced and delivered to KI
Results from vaccine and challenge study (opens in new window)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 (opens in new window)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 (opens in new window)Dispensing of the vaccine candidate
QC tested and QP released GMP plasmid drug product (opens in new window)QC tested and QP released GMP produced vaccine candidate
Protocol for neutralization assay (opens in new window)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 (opens in new window)Report that describes the long term stability of the vaccine candidate
Selection of the best vaccine candidate for GMP and tox studies (opens in new window)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 (opens in new window)Written plan with the design of the toxocological study of the vaccine candidate
Manufactured GMP grade bulk drug substance pDNA (opens in new window)Production of a GMP grade bulk drug substance of the vaccine candidate
QC tested and QP released GMP drug substance (opens in new window)Release of a GMP produced vaccine candidate
A single step delivery procedure (opens in new window)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 (opens in new window)Establish a Communication and Dissemination Plan
Optimization of selected vaccine candidates to further avoid a cytokine storm (opens in new window)ORF mutants of vaccine candidates that lost the ability to activate pro-inflammatory responses
Assays to measure cytokine induction and IFN supression (opens in new window)Primers, RT-qPCR assays, transfection protocols, control constructs, transfection protocols, reporter assays
Report writing for the IMPD, month (opens in new window)A written report of the toxicological evaluation of the vaccine candidate according to GLPto be submitted to EMAMPA
Midterm recruitment report (opens in new window)Approvals from ethics committee and EMA/MPA for phase I clinical trial (opens in new window)
Completed clinical trial in humans and writing of report (opens in new window)
Summarizing stability data report(s) for plasmid drug product (opens in new window)
Written reports on the stability of the GMP produced vaccine candidate
Pre-Production Evaluation and plasmid production for toxicology studies (opens in new window)Complete study report on the manufacturing system performance and plasmid production for toxicological evaluation.
Consortium secured intranet and Management handbook (opens in new window)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 (opens in new window)Generation of a Master cell bank for the vaccine and QP release
A locked Cliniporator with pulse pattern for plasmid DNA delivery (opens in new window)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 (opens in new window)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 (opens in new window)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 (opens in new window)Completed toxicological evaluation according to GLP of the vaccine candidate
Optimization selected vaccine candidates to further avoid of suppression of IFN induction (opens in new window)ORF mutants of vaccine candidates that lost the ability to suppress IFN induction
Challenge protocol (opens in new window)Established 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, 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
Searching for OpenAIRE data...
There was an error trying to search data from OpenAIRE
No results available