A clinical research network to improve the management of Monkeypox virus disease

Project Information

MPX-RESPONSE

Grant agreement ID: 101115188

DOI

10.3030/101115188

EC signature date 14 April 2023

Start date 5 August 2022

End date 4 August 2026

Funded under

• Health

Total cost

€ 11 999 999,30

EU contribution

€ 11 999 999,30

Coordinated by

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France

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

Documents, reports (8)

MOSA study Statistical analysis plan

A clear and prospective document detailing all statistical analyses to be performed in the MOSA trial.

UNITY study Statistical analysis plan

A clear and prospective document detailing all statistical analyses to be performed in the trial.

TSC, TCT, DSMB and CLC Secretariat charters

Governing documents detailing the mandate for each of the trial committees and boards.

UNITY Data Transfer and user Agreements templates

Template for agreements governing the data sharing/integration

Guidelines on how to implement a centralised pharmacovigilance system

Describes how a centralised pharmacovigilance system is implemented

Study initiation package EPOXI

Registration number of the clinical study in a registry meeting WHO Registry criteria. Final version of study protocol as approved by the regulator(s) / ethics committee(s) Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Safety Management Plan

Describes the governance the safety circuit and communication of the trial The safety communication between the trial safety group InsermANRSMIE and Sponsors representatives with the trial committees TCT TSC DSMB will be described

MOSA Study initiation package

Registration number of the clinical study in a registry meeting WHO Registry criteria.Final version of study protocol as approved by the regulator(s) / ethics committee(s)Regulatory and ethics (if applicable, institutional) approvals required for the enrollment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Data Management Plan (1)

UNITY and MOSA Data Management Plan, first version

Describing the data management of the UNITY and MOSA trials

Websites, patent fillings, videos etc. (1)

Project website

Project website and Internal communication tools

Publications

Peer reviewed articles (3)

MOSAIC: A cohort study of human mpox virus disease

Author(s): Pesonel, E; Hoffmann, I; Guiraud, L; Bourner, J; Diallo, A; Dunning, J; Horby, P; Kali, S; Laouénan, C; Mentré, F; Merson, L; Molino, D; Palich, R; Rojek, A; Tacconelli, E; Tardivon, C; Yazdanpanah, Y; Calmy, A; Lescure, F-X; Olliaro, P
Published in: Wellcome Open Research, 2023, ISSN 2398-502X
Publisher: London: Wellcome Trust
DOI: 10.12688/WELLCOMEOPENRES.19616.1

Nature Medicine

Author(s): Erica Telford, Beatriz Grinsztejn, Inge Christoffer Olsen, Nicolas Pulik, France Mentré, Skerdi Haviari, Maxime Hentzien, Olivier Ségéral, Miquel B. Ekkelenkamp, Dimie Ogoina, Nathalie Strub-Wourgaft, Alpha Diallo, Yazdan Yazdanpanah, Alexandra Calmy
Published in: Nature Medicine, 2023, ISSN 1078-8956
Publisher: Nature Publishing Group
DOI: 10.1038/s41591-023-02393-6

Orthopoxvirus-specific antibodies wane to undetectable levels 1 year after MVA-BN vaccination of at-risk individuals, the Netherlands, 2022 to 2023

Author(s): Leanne PM van Leeuwen, Marc C Shamier, Babs E Verstrepen, Hannelore M Götz, Katharina S Schmitz, Najlae Akhiyate, Koen Wijnans, Susanne Bogers, Martin E van Royen, Eric CM van Gorp, Marion PG Koopmans, Rory D de Vries, Corine H GeurtsvanKessel, Luca M Zaeck
Published in: Eurosurveillance, Issue 29, 2024, ISSN 1560-7917
Publisher: European Centre for Disease Control and Prevention (ECDC)
DOI: 10.2807/1560-7917.ES.2024.29.38.2400575