Network composition

The Clinical investigation centres (CIC), Clinical research centres (CRCs) and Departments of Tropical and Infectious diseases, members of the I-REIVAC network, are in charge of implementing and carrying out vaccine clinical trials.

They ensure trials run smoothly by overseeing:

• the recruitment, vaccination and follow-up of participants in compliance with the protocol;
• data collection and input in compliance with the data management plan;
• processing, storing and sending samples to Biological Resource Centers (see below) in line with quality standards;
• reporting adverse events (AEs) and serious adverse events (SAEs) to regulatory authorities.

The Biological Resource Centres (BRCs) also play a crucial role in the successful completion of vaccine clinical trials. They provide methodological support for trial design, advising on the type, quantity and quality of samples required to meet the study objective.

The roles of BRCs is to receive, prepare, process, preserve and ensure the availability of different types of biological resources (plasma, serum, saliva, Peripheral Blood Mononuclear Cells (PBMCs) and nucleic acids). These resources must meet high quality standards, which is why all BRCs are certified NF S96-900 or ISO 20387, ISO 9001. The BRCs' quality management system guarantees the traceability of all preparations, as well as compliance with best practices and regulations. The CRBs are part of a continuous improvement approach through corrective and preventive actions, which enables them to meet the needs of the research laboratories.

A network of immunology laboratories was set up during the pandemic. The eleven member laboratories, with specific and complementary immunological skills, allow for the analysis of different types of immunological responses: humoral, cellular and mucosal. Experts from these different laboratories draw up the list of analyses that are to be carried out, as well as the most relevant kinetics in order to obtain the most exhaustive scientific data to answer the different scientific questions.

The Methodology and Management centers (MMCs) and Clinical Research Units (CRUs) associated with the I-REIVAC network contribute, among other things, to publicly promoted vaccine clinical trials (national & international), from their methodological design to the valorisation of their results.

These structures are made up of methodologists, data managers, biostatisticians, project managers and ARC monitors. They bring together all the skills and resources needed for methodological design ; protocol and comment report development ; trial set-up, coordination and monitoring ; data management ; statistical analysis and interpretation of data ; Quality Assurance ; and financial management of studies.

The I-REIVAC network works closely with the Observatoire Régional de la Santé de Provence-Alpes-Côte d'Azur (ORS PACA) and the Centre de recherche médecine, sciences, santé, santé mentale, société (CERMES), an INSERM laboratory.

The network carries out human and social science surveys aimed at better understanding the profile, motivations and perceptions of volunteers, and more broadly those of the general population, with regard to vaccination, clinical research, health and public institutions.

Indeed, these dimensions are important. As the COVID-19 pandemic very much made evident, societies' relations to science are a major public health issue. Furthermore, identifying the factors favouring volunteer participation in clinical trials could help target more rapidly the volunteer populations most likely to take part in clinical research in the field of vaccination.