Clinical Studies
Pillar objectives
Pillar 3 aims to develop an advanced approach for accelerating clinical testing, focusing on flexible trial operations and innovative study designs. This includes trial decentralization, overlapping seamless trials, and template clinical trial protocols with regulatory and ethical review institutions.
WP10 Phase I/II clinical studies (Lead: UA; Partners involved: Inserm, LUMC, KUM, UKE, UT, UMR, FBS, UNISI)
- Develop a network of highly experienced clinical trial sites capable of generating human data for vaccine and antibody prototypes with pandemic potential
- Generate human data on safety and immune response through Phase I/II clinical trials of medical countermeasures (MCMs) targeting prototype pandemic pathogens most relevant for the European ecosystem
- Contribute to the Partnership’s “ever-warm” clinical trials system for vaccines and antibodies ready, audited and tested, by setting-up an efficient network of clinical sites and generating human clinical data and potentially pandemic prototypes
WP11 in Controlled Human Infection Models (CHIMs) (Lead: LUMC; Partners involved: UA, UT)
- Develop a network of laboratories (academic and CDMO) with the capability to isolate, attenuate and GMP produce challenge strains of priority pathogens
- Establish a European network of clinical trial sites that are equipped for CHIMs studies, leveraging from existing networks and collaboration
- Develop and template clinical trail protocols in collaboration with regulators and collaboration sites
- Perform vaccine vaccine-CHIM study for a selected priority pathogen and prototype
WP12 Vaccine immunology (Lead: ULB; Partners involved: UMR, HMGU, KUM, UT, IP, UNISI, IZSVe)
- Set-up and coordinate a network of immunology laboratories supporting clinical trials and generating standardised vaccine immunogenicity data across Europe
- Identify, set-up and qualify core assays to support clinical trials for the assessment of immune responses and protection following vaccine administration
- Set-up a pipeline of candidate and exploratory immunoassays to characterise vaccine-induced immune responses and to potentially serve as future core immunoassays for vaccine trials against target pathogens
- Set-up procurement of key reagents and clinical samples standards through the implementation of calls to identify industry Partners able to rapidly procure high quality reagents for standardised immunoassays
• Led by Vaccinopolis (Antwerp - UA, Belgium)
• Pillar 3 Leader: Pierre Van Damme (Vaccinopolis - UA)
• Pillar 3 Co-Leader: Marie-Astrid Hoogerwerf (Leids Universitair Medisch Centrum, LUMC, Netherlands)