Submission of the First EVH Multicentre Vaccine Trial

As part of Pillar 3 – Clinical Studies, the European Vaccines Hub (EVH) successfully achieved a major milestone in 2025 with the submission of its first multicentre Phase 4 vaccine trial to the Clinical Trial Information System (CTIS). This accomplishment marked a significant step forward in consolidating EVH’s clinical research capacity shortly after the formal launch of its four operational Pillars on 1 March 2025.

About the Study
The trial was designed to:

• Assess the safety and immunogenicity of the zoonotic H5N8/MF59 influenza vaccine in volunteers previously vaccinated with H5N1/MF59 compared with H5 naïve participants.
• Establish harmonized approaches for evaluating systemic and mucosal immune responses to influenza vaccination across the EVH network of immunological laboratories.

Clinical Site Preparedness
The two participating clinical centres — located in Antwerp, Belgium, and Siena, Italy — completed all preparatory activities and are ready to initiate enrolment pending ethical and regulatory approval. Their coordinated efforts demonstrated the EVH clinical network’s operational readiness and collaborative strength, extending effectively across counties.

Impact and Contribution to Pandemic Preparedness
Led by the Université libre de Bruxelles (ULB), Belgium, this study contributes to strengthening Europe’s pandemic preparedness by broadening the scientific evidence base on immune responses to influenza vaccination. The knowledge generated will support the accelerated development and deployment of pandemic vaccines, in line with the EVH mission and HERA’s mandate to reinforce Europe’s capacity to respond to emerging infectious threats.
This achievement reflects the commitment of all EVH Partners to advancing high quality collaborative research and to building a robust, cohesive European vaccine ecosystem.


11 July 2025