I-REIVAC

The network conducts clinical research projects: clinical trials (phases 1 through 3), real-world studies (phase 4), large-scale epidemiological studies (cohort studies, cross-sectional studies, etc.) and is also developing a social science approach, particularly regarding the acceptability of vaccination programs.

The I-REIVAC network’s mission and goal is to promote clinical research in vaccinology and monoclonal antibodies, both nationally and internationally, by:

• Enhancing France’s appeal for conducting industrial trials, particularly early-phase studies (Phases I and II);
• Boosting clinical research, particularly in the areas of vaccination for specific populations (patients with comorbidities, immunocompromised individuals, the elderly, etc.)
• Helping prepare for future pandemics (emergence);
• Promoting the emergence of translational research (or exploratory research) through interactions between clinicians, biologists, academic researchers, and industry professionals;
• Formalizing public-private partnerships particularly with research teams, specialty networks—particularly other F-CRIN-certified networks—as well as industrial and institutional stakeholders;
• Expanding the network’s activities to include new stakeholders such as private practice physicians or in strategic areas related to innovative therapies;
• Fostering new collaborations at the European and international levels.

I-REIVAC is coordinated by Prof. Odile Launay, an infectious disease specialist and vaccine researcher at Cochin Hospital in Paris, and Prof. Eric Tartour, an immunologist at HEGP Hospital in Paris. 

The I-REIVAC network coordination team serves as the single point of contact for all network-related requests from all partners: researchers and institutional and industrial partners/sponsors. In particular, it is responsible for coordinating and monitoring the activities and projects implemented within the network, as well as preparing for and following up on the governance committees (Steering Committee and Scientific Advisory Board).

The network also brings together at the national level:

• more than thirty clinical centers (Clinical Investigation/Research Centers (CIC/CRC) and/or Infectious and Tropical Diseases Units (SMIT)) responsible for the implementation and conduct of vaccine clinical trials.
• A network of biological resource centers (CRB) certified to NF S96-900 or ISO 20387 standards, ISO 9001, including 3 coordinating centers that contribute their expertise to the conduct of the trials (sample quantity and quality, PBMC preparation, etc.).
• A network of about ten immuno-monitoring laboratories, each with specific and complementary immunological expertise, enables the analysis of different types of immune responses: humoral, cellular, and mucosal.
• Three methodology and management centers (CMG), which contribute to academically-led vaccine clinical trials (national and international), from methodological design to the dissemination of results.
• Collaborations with research centers in Human and Social Sciences (SHS) to conduct surveys aimed at better understanding the profile, motivations, and perceptions of volunteers and the general public regarding vaccination, clinical research, health, and public institutions.

I-REIVAC provides interested academic and industrial partners with a one-stop shop for vaccinology research through a wide range of expertise:

• Conducting trials of new vaccines and monoclonal antibodies for the prevention of infectious diseases;
• Vaccination of specific populations by promoting the development of international collaborations, particularly among patients with rare and/or complex diseases (immunocompromised individuals, diabetics, patients with autoimmune diseases, solid organ transplant recipients, hematopoietic stem cell transplant recipients, pregnant women, and older adults) with an assessment of the benefit-risk ratio of vaccination in these populations;
• Evaluation of immunological mechanisms and determinants of the vaccine response, including the identification of biomarkers and correlates of protection;
• Epidemiological studies and studies on the burden of vaccine-preventable diseases;
• Development of the Humanities and Social Sciences (SHS) research track and understanding the determinants of acceptance or refusal of various vaccines.

During the COVID-19 pandemic, the Ministry of Health and Solidarity and the Ministry of Higher Education and Research asked Inserm, in coordination with numerous French hospitals, to strengthen and expand the I-REIVAC network to conduct trials of COVID-19 vaccines. A national registry of CoV-Ireivac volunteers (I-REIVAC Volunteer Community) was launched, bringing together individuals volunteering to participate in vaccine research. 

The registry now includes more than 55,000 adult volunteers and 390 children. It enables centers in the I-REIVAC network to pre-identify a large number of volunteers quickly, thereby facilitating the conduct of clinical research projects. It also makes it possible to identify specific populations (those with hypertension, diabetes, or immunocompromised individuals). Initially dedicated to vaccine research against SARS-CoV-2, it has been open since November 2022 to all vaccine research conducted within the I-REIVAC network.

Several studies are underway, with the aim of informing public health policies:

Supported by Inserm - ANRS MIE and co-led by AP-HP, with funding from the National Research Agency (ANR) as part of the France 2030 plan for five years (ANR-24-MIEM-0002), the I-REIVAC Emergence platform was established to strengthen the structure of the national I-REIVAC network.

The objective: to consolidate and enhance France’s capacity to respond rapidly and effectively to the implementation of vaccine trials, particularly during disease outbreaks, by ensuring effective coordination among the various stakeholders in the sector to develop innovative solutions and provide the scientific evidence necessary for decision-making.

I-REIVAC Emergence is based on:

• strengthening clinical research infrastructure. The project supports 10 clinical research centers, : AP-HP (Cochin and Saint-Antoine Hospitals), Dijon, Lyon, Lille, Montpellier, Nantes, Rennes, Saint-Étienne, and Tours;
• the preparation and coordination of biological sample management through 8 biological resource centers (CRBs), including three coordinating CRBs linked to the ANRS MIE and Bordeaux University Hospital biobank;
• the standardization and automation of immunomonitoring tests for rapid and reliable assessment of immune responses through a network of 6 partner immunomonitoring laboratories;
• support for research through 3 Methodology and Management Centers (CMG) selected for their expertise in vaccinology;
• the development and management of the national volunteer registry which included more than 55,000 registered individuals at the time of the COVID-19 pandemic, to increase the mobilization of research participants and recruitment capacity in clinical trials.