Jointly supported by Inserm / ANRS Emerging Infectious Diseases and the AP-HP, the I-REIVAC Emergence platform seeks to reinforce the structure of the national I-REIVAC network developed during the Covid-19 pandemic. Its aim is to consolidate and increase France's capacity to respond rapidly and effectively to the implementation of vaccine studies, particularly during emergence events, by ensuring effective coordination between the different players in the sector in order to develop innovative solutions and provide the scientific input required for decision-making.
Consolidating and strengthening existing infrastructures
To prepare for future health crises, the strategic objectives of this platform aim to consolidate existing infrastructures, in particular with "emergence" referral centres ready to mobilise significant resources for large-scale trials. The I-REIVAC Emergence platform hinges on:
- the consolidation of clinical research infrastructures. The project supports 10 clinical investigation centres, in 9 CHU: AP-HP (Cochin and Saint-Antoine hospitals), Dijon, Lyon, Lille, Montpellier, Nantes, Rennes, Saint-Étienne and Tours;
- the support of research by 3 methodology and management centres (CMG) selected for their expertise in vaccinology;
- the preparation and coordination of biological sample management via 8 biological resource centres (BRCs), including three coordinating BRCs in conjunction with the ANRS MIE and Bordeaux University Hospital biobank ;
- the standardisation and automation of immuno-monitoring tests for rapid and reliable assessment of immune responses by a network of 6 partner immuno-monitoring laboratories;
- the evolution and animation of the national registry of volunteers, which includes over 55,000 people registered at the time of the Covid-19 pandemic, to increase the mobilisation of research participants and recruitment capacities in clinical trials;
8 lines of action
The I-REIVAC Emergence platform aims to guarantee optimal responsiveness in the event of a crisis through 8 lines of action:
- coordination, operation and governance of the various players involved in inter-crisis and crisis situations, in particular to adapt crisis management plans to ensure rapid mobilisation of the resources and expertise of the I-REIVAC-Emergence platform in the event of an epidemic, in conjunction with the ANRS MIE crisis unit
- coordination and scientific development of clinical vaccine research, in particular by optimising organisation, and simplifying regulatory processes to help accelerate the implementation of clinical trials;
- Strengthening the resources of the CICs by ensuring the sustainability of medical staff who can be mobilised in the event of an outbreak;
- establishing interoperability of trial methodology in particular in conjunction with the CMGs, with the development of source protocols to standardise methodological protocols and improve data management to facilitate sharing ;
- setting up sample management via the CRB network in liaison with national bio-banks : automation, standardisation and certification of preparations;
- optimising the reproducibility of results from immuno-monitoring laboratories: automation, standardisation and certification of immunological tests, relying in particular on technological innovations, such as high-throughput serology tests or bioinformatics predictive models;
- ensuring the operation of the national register of volunteers ready to be mobilised to advance French vaccine research;
- developing human and social science (SHS) studies, notably on the acceptability of vaccination and vaccine research, to anticipate behaviours in the advent of vaccination campaigns and to build appropriate communication strategies.
Funding
The I-REIVAC Emergence platform is funded to the tune of 12 million euros by the French National Research Agency (ANR) as part of measure 6 of the national strategy "Emerging infectious diseases and Nuclear radiological biological and chemical threats" of the France 2030 plan for a five-year period (ANR-24-MIEM-0002). The platform is jointly supported by Inserm / ANRS MIE and AP-HP.
National and European interconnections
The I-REIVAC-Émergence platform is linked to other national platforms funded by the France 2030 acceleration strategy for emerging infectious diseases, and similarly supported by ANRS MIE/Inserm, such as:
- EMERGEN 2.0, platform for genomic surveillance and research on emerging pathogen infections. The EMERGEN 2.0 platform is coordinated by Inserm / ANRS MIE, SpF and Anses, and notably involves the network of CNRs for the human pathogens in question, as well as the ANRS MIE network of hospital laboratories in virology and medical pharmacology. Funding: €12m
- OPEN ReMIE, a therapeutic clinical research platform that aims to prepare and organise interventional clinical research, of academic or industrial promotion, on emerging and re-emerging infections, and in an articulated and integrated manner with international research networks. The OPEN-ReMIE project will be led by Inserm/ANRS-MIE and co-sponsored by the Hospices Civils de Lyon (HCL). Funding: €10m
An inter-platform committee will help coordinate these various national initiatives, particularly in the event of a health crisis.
I-REIVAC-Émergence is also part of a national dynamic around vaccine research led by the Inserm and the French BioCluster for Innovation in Infectious Diseases (BCF2I) (coordinated by Lyonbiopôle) in which Inserm/ANRS MIE and AP-HP are partners.
I-REIVAC Emergence will also strengthen collaborations with other key players in clinical research, such as the FCRIN network, PedStart for vaccine research in the pediatric population, or the laboratoire P4 de Lyon, in order to respond to the most severe infectious threats.
Internationally, I-REIVAC-Émergence fits in with European initiatives such as the European Vaccin Hub (EVH) of the Health Emergency Preparedness and Response Authority (HERA) coordinated for France by the Institut Pasteur.
