EVH completes its first clinical trial, marking a new milestone for European pandemic preparedness

The European Vaccines Hub has reached an important milestone with the successful completion of the clinical activities of FLU-SEQ, the first clinical trial initiated within the EVH project.

The study was conducted as part of Pillar 3 – Clinical Studies, which aims to strengthen Europe’s capacity to carry out coordinated and standardised clinical trials and immunological analyses in support of pandemic preparedness.

FLU-SEQ investigated the safety and immunogenicity of the zoonotic H5N8/MF59 influenza vaccine in volunteers who had previously been vaccinated with H5N1/MF59, compared with H5-naïve participants.

The trial also addressed a broader objective of the European Vaccines Hub: the development of harmonised approaches for evaluating both systemic and mucosal immune responses across the EVH network of immunological laboratories. Establishing shared methodologies and coordinated clinical procedures is an important part of building a European research infrastructure capable of responding rapidly and effectively to emerging health threats.

The two participating clinical centres, located in Antwerp, Belgium, and Siena, Italy, have now completed their activities. Data generated by the study are currently being analysed.

The completion of FLU-SEQ represents an important achievement in EVH's clinical activities and demonstrates the value of combining expertise and infrastructure across the European network. The study was carried out through a successful collaboration between Vaccinopolis and Harmony Clinical Research, supporting the clinical development and evaluation of vaccines with a focus on European pandemic preparedness.

As EVH continues to develop its clinical research capacity, further trials are already being planned, building on the experience and collaborative framework established through FLU-SEQ.

This first completed study therefore represents an important step towards EVH’s wider goal to achieve and maintain the highest level of EU pandemic readiness.