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First Controlled Human Infection study at Vaccinopolis in collaboration with NIVI Research Center and support from Province of Antwerp

Antwerp – Copenhagen – Oct 22nd 2025: Vaccinopolis, the unique clinical research facility at the University of Antwerp in Belgium, is pleased to announce the completion of the quarantine phase of the FLAIM study. Within this study 24 participants have been inoculated with a well characterized influenza virus (H3N2 strain A/Belgium/4217/2015, purchased through a collaboration with SGS CPU) to study viral replication, shedding and airway immunity.

The participants were carefully selected and remained in quarantine at Vaccinopolis for 13 days. All 24 participants completed the study and were in general very positive about their stay. In total 20 of 24 participants developed a mild infection and viral replication was observed. Currently over 3900 samples have been collected and will be studied in detail in the coming months in various labs in Antwerp, Leuven, Copenhagen and Rome. This study has been made possible by financial support from NIVI Research Center as well as the Development Authority of the province of Antwerp. Besides the financial contribution, NIVI Research Center, based at the University of Copenhagen, will play a key part in unraveling the airway immunity objectives.

Responding quickly to an impending pandemic

The scientific goal of this study is to correlate viral replication in the nose and upper airway with exhaled breath analysis to generate an in depth understanding of viral shedding. This is important in view of potential future epidemics to ensure that appropriate measures can be taken based on well-studied scientific evidence. Next to viral replication, the airway immunity will be studied to better understand mucosal protection, viral shedding and enable development of more potent and powerful vaccines that can block transmission.

Prof. Pierre Van Damme, Director Vaccinopolis: ‘FLAIM represents a huge step in unlocking the full potential of Vaccinopolis to contribute in pandemic readiness. Understanding viral shedding and airway immunity is a key enabler to act fast on pandemic threats. We are grateful to the collaboration with NIVI and the support from the Province in realizing this project.’

Building an innovative ecosystem together

Prof. Dr. Thor Theander, Executive Director NIVI Research Center: ‘We are very proud to collaborate with Vaccinopolis on the FLAIM study, which has the potential to uncover vital insights into viral replication, shedding, and airway immunity for one of NIVI’s key target respiratory pathogens. FLAIM aligns closely with NIVI’s mission to harness airway immunity for the research and development of new vaccines to prevent airborne epidemics, and will be an important step on that path.’

The Development Authority of the province of Antwerp (POM Antwerp) also lent its support to the project. ‘The collaboration between the province and Vaccinopolis is a good example of how we are working together to build an innovative ecosystem,’ explains Luk Lemmens, deputy for the province of Antwerp. He is responsible for Economy and Innovation. “We are joining forces to stimulate research that not only yields scientific knowledge, but also creates social and economic added value. The life sciences sector is an economic powerhouse in the province of Antwerp. That is why the province continues to invest in it. POM Antwerp plays a key role in this: at the Science Park in Niel, POM Antwerp brings together start-ups and companies working in the fields of health, biotechnology and pharmaceuticals.”

About Vaccinopolis

Vaccinopolis is the brand new clinical research infrastructure of UAntwerpen with state-of-theart controlled human challenge trial (CHIM) facility as well as ambulatory vaccine trial unit and lab facility. The CHIM facility operates under Biosafety level-3 conditions and has a total capacity of 30 negative pressure rooms. The ambulatory trial unit has performed over 550 clinical trials and is ISO9001 accredited. The mission of Vaccinopolis is to safeguard public health by performing high quality translational clinical research in the field of infectious diseases. https://www.vaccinopolis.be

About NIVI and NIVI Research Center

The Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI) brings together leading experts in immunology and vaccine development from Denmark and around the world to develop vaccine candidates against some of the most important and deadly respiratory pathogens. In so doing, NIVI aims to create a knowledge hub in airway immunity and establish vaccine development pipelines that can bridge the gap between academic research and industry innovation.

The initiative is comprised of two distinct entities:
1) NIVI Research Center: NIVI Research Center strives to be a world-leading academic research center anchored at the Department of Immunology and Microbiology at the University of Copenhagen. NIVI Research Center directs the research, discovery and educational aspects of the NIVI initiative.
2) NIVI Development: NIVI Development is a limited liability company owned by the Novo Nordisk Foundation. NIVI Development enables the translational efforts of NIVI by providing industry-level expertise in vaccine development and conducting clinical studies for new vaccine candidates.
https://niviresearch.ku.dk

About POM Antwerp

POM Antwerp, the Development Authority of the Province of Antwerp, works to promote a strong, future-oriented economy in the province of Antwerp. We connect local authorities, businesses and knowledge institutions to achieve smart and sustainable solutions. POM Antwerp supports local authorities in area development, business parks and projects related to energy, mobility and the circular economy. For businesses and organisations, POM offers specialised infrastructure, innovation campuses and business sites, and encourages collaboration within innovative ecosystems. In this way, the organisation strengthens entrepreneurship, sustainable growth and social added value in the region.

Contact: Bart Van Meerbergen, Head of Operations at Vaccinopolis, vaccinopolis@uantwerpen.be