Emerging and re-emerging viral infections represent one of the most complex challenges for global public health. Among these, Enterovirus D68 (EV-D68) is emerging with increasing urgency due to recurring outbreaks associated with severe respiratory illnesses and neurological complications in children.
Despite its growing epidemiological significance, there are currently no approved specific vaccines or antiviral treatments for EV-D68. To address this critical gap, we have submitted the EVD68-VAXREADY project proposal (“Integrated EV-D68 Vaccine Development from Surveillance to Phase I Clinical Evaluation”) under the European Horizon Europe program (Call HORIZON-HLTH-2026-01-DISEASE-04).
The goal: an integrated “Surveillance-to-Clinic” pipeline
The core vision of EVD68-VAXREADY lies in establishing a fully integrated pipeline that directly connects epidemiological surveillance data with antigen selection, industrial manufacturing, and human clinical evaluation.
By leveraging European monitoring networks, the project plans to establish standardized immunological assays to quantify binding and neutralizing antibody responses. A key focus will be the identification of immune signatures of protection with special attention to sex and age variables, ensuring equitable and effective vaccines across all population groups.
The project aims to culminate in a Phase I clinical trial in healthy adult volunteers to evaluate safety and immunogenicity, establishing a clear pathway for subsequent clinical development steps.
A European Partnership for Epidemic Readiness
Led by the Instituto de Salud Carlos III (ISCIII) in Spain, the proposed consortium brings together leading scientific, clinical, and industrial institutions across Europe, including:
- Instituto de Salud Carlos III (Spain)
- Agencia Estatal Consejo Superior de Investigaciones Científicas – CSIC (Spain)
- Certest Biotec S.L. (Spain)
- Servicio Madrileño de Salud / Fundación para la Investigación Biomédica del Hospital La Paz (Spain)
- R-Evolution Worldwide – Impresa Sociale (Italy)
- Fondazione IRCCS Policlinico San Matteo (Italy)
- Vismederi Srl (Italy)
- Università degli Studi di Milano (Italy)
- Statens Serum Institut (Denmark)
- Medicines and Healthcare products Regulatory Agency – MHRA (United Kingdom)
- Turun Yliopisto (Finland)
- Nacionalni Laboratorij za Zdravje, Okolje in Hrano – NLZOH (Slovenia)
If selected for funding, EVD68-VAXREADY will significantly enhance Europe’s capacity to prepare for and rapidly respond to emerging viral threats.
The Role of R-EVOWW
As a partner in this application, we will bring our expertise in ethical and regulatory management, clinical protocol development, and trial execution planning in compliance with international ICH-GCP standards.
R-EVOWW will coordinate the preparation of translational and clinical stages to ensure adherence to the highest quality, ethical, and regulatory standards, facilitating the rapid translation of scientific discoveries into real-world clinical applications upon funding.
