ISIDORe – Integrated Services For Infectious Diseases Outbreak Research

Project Acronym ISIDORe
Funding Programme Horizon Europe
Budget 20,998,624.00
Coordinator ERINHA
Website https://isidore-project.eu/
Starting-ending date: 1 February 2022 - 1 January 31 2025

About ISIDORE 

The ISIDORe consortium will improve Europe’s global service and research capacities by becoming a key, ERA-embedded instrument for supporting research on epidemic-prone pathogens, and aims at contributing to fighting the rise of the SARS-CoV-2 variants through a global, integrated and challenge-driven approach by providing fast access to cutting-edge resources and services to scientific user communities for supporting the evidence-based development or adaptation of countermeasures in times of emergency. Secondly, the project aims at contributing to Europe’s readiness to any epidemic-prone pathogen through a global, integrated and preparedness-driven approach by providing access to cutting-edge resources and services to scientific user communities for supporting their research projects in the field of infectious diseases in “peaceful times” as well as during epidemics.

 

Submit an ISIDORe-EATRIS TNA proposal

If you wish to submit a TNA research proposal or regulatory services, please download this ISIDORe EATRIS TNA Application form, complete it, sign it and email it to Patricia Carvajal (patriciacarvajal@eatris.eu) and David Morrow (davidmorrow@eatris.eu).

ISIDORE Consortium 

ERINHA, other ESFRI Life Sciences research infrastructures and networks, all conducting activities that are highly relevant to the Research infrastructure services for rapid research responses to COVID-19 and other infectious disease epidemics topic, formed a multidisciplinary consortium to respond to the new research needs that constantly arise from the emergence of SARS-CoV-2 variants. 

It has mobilised and engaged over 150 access providers from 31 different countries that committed to dedicate part of their capacities to the ISIDORe project to offer scientific communities access to their facilities, resources and equipment, and ultimately advance research on SARS-CoV-2 variants and infectious agents of public health concern. 

The development of the ISIDORe project, and the capacities presented in the proposal, are the result of the work and commitment of a ‘core consortium’ of 17 entities:  

  • 6 EU-funded networks: EVA, VetBioNet, INFRAVEC, Sonar-Global, TRANSVAC, MIRRI;  
  • 1 nationally-funded surveillance network: EMERGEN;  
  • 10 legally established ESFRI infrastructures: INSTRUCT, EuBi, EU-OS, ECRIN, EATRIS, BBMRI, INFRAFRONTIER, EMBRC, ELIXIR, and ERINHA. 

 

EATRIS role in the project 

EATRIS is the leader of WP12, which involves coordinating the access of selected users to their immune monitoring and profiling services. EATRIS will also provide expertise on regulatory requirements for trial authorisation, ethics committees, fast track procedures, coordinated authorisation in WP15 as co-leader. In close collaboration with ECRIN and TRANSVAC for vaccine trials, EATRIS will focus on the quality of the data, the robustness of the trial and the cost containment. 

Concluded TNA projects and key achievements

Below are examples of Transnational Access (TNA) projects in ISIDORe, where EATRIS contributed its services to accelerate the development of new products and protocols for patient benefit. Click on each title and read more about the TNA project.

Pharma Holdings developed a nasal spray for SARS-CoV-2 and Influenza using LTX-109. ISIDORe-EATRIS provided regulatory advice on bridging studies needed for clinical trials. The advice guided interactions with CROs, facilitated EMA scientific advice requests, and supported ISIDORe applications for in vivo studies. The regulatory input was timely and impactful, leading to improved formulation qualification.

Sferogen, developing a virus-like particle vaccine, received broad regulatory advice from EATRIS on national regulatory interactions, guidelines, preclinical study planning, and Target Product Profile design. The input shaped internal planning and laid the groundwork for future regulatory steps.

Fabentech received strategic input for a phase 2b COVID-19 therapeutic trial. ISIDORe support included epidemiologic data, competitive landscape, trial design guidance, and statistical recommendations. The input was integrated into protocol development, with future exploitation in a European consortium.

To compare PRRSV and influenza immune responses in pigs, serum cytokines were analysed using ISIDORe support. CXCL13, BAFF, and IL-5 were upregulated in PRRSV infections, suggesting ineffective immune responses. Results shared on BioRxiv. ISIDORe enabled full exploitation of earlier VetBioNet experiments.

Following promising phase IIB results, ISIDORe-EATRIS provided advice for a global phase III trial evaluating metformin and NAC for post-TB lung damage. The team designed a robust, multicenter protocol incorporating WHO feedback, with open data dissemination planned. The support was vital for regulatory strategy and trial refinement.

IdiPAZ conducted a phase II trial using SARS-CoV-2-specific CD45RA-T cells. ISIDORe supported CyTOF-based immune profiling. Findings showed increased Tcm and Tem cells post-infusion in treated patients, indicating enhanced immune recovery in lymphopenic COVID-19 patients—results to be published.

ISIDORe immunomonitoring confirmed no plasmid integration in KlebsiGene vaccine-transfected cells. Transcriptional differences were observed, contributing to ongoing safety validation. The study supports regulatory alignment and positions the vaccine for clinical testing. Timeline extended to June 2025.

KlebsiGene DNA vaccine project received EATRIS regulatory advice, defining its European regulatory scope. Key quality, safety, and efficacy criteria were mapped. A Target Product Profile was drafted. The advice supports the transition to pre-clinical trials and future market readiness.

NEVEZYNE explored regulatory pathways for silkworm-based vaccine production. EATRIS advised on TPP development and preclinical data strategy. Consultation reinforced the company’s biologics development plan and strategic positioning. Work is ongoing to validate the TPP.

A study on SARS-CoV-2 in 428 healthcare workers utilised PBMCs for T cell marker analysis. Low cell survival limited results. Extensive marker profiling was completed, showing some immune changes, but not antigen-specific responses. Cytokine analyses were not pursued. Results from parallel studies will be disseminated.

Through ISIDORe support, 204 SARS-CoV-2 samples from healthcare workers were sequenced, with 169 passing QC for lineage and mutation analysis. Phylogenetic insights revealed associations between variants (especially JN.1) and clinical symptoms such as malaise, ARI, and anosmia. High concordance (98.5%) was seen between WGS and RT-PCR variant calls, though only 25.3% aligned on lineage. Findings reinforce WGS utility in molecular epidemiology and healthcare surveillance. Results are contributing to EU-level publications and conferences.

The ONCHOVAX project aims to translate from preclinical to phase I clinical trials the two potential vaccine candidates in the assessment of safety and immunogenicity against onchocerciasis from animal models during preclinical assessments to healthy adults (phase1a) and exposed (phase 1b) adults. EATRIS supported user giving regulatory advice and customised template for TPP development for regulatory roadmap design.

Contact

David Morrow
 Scientific Lead Advanced Therapies
davidmorrow@eatris.eu