VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe

• Title in English: Síť VACCELERATE: definice kapacity klinických studií v Evropě v reálném čase
• Authors: SALMANTON-GARCIA Jon; WIPFLER Pauline; VALLE-SIMON Paula; MERAKOU Christina; KOPSIDAS Ioannis; BETHE Ullrich; STEINBACH Angela; SPIVAK Orly; SOUČKOVÁ Lenka; MENDONCA Maria Amelia; KONIORDOU Markela; HELLEMANS Margot; FRIAS-INIESTA Jesus; DAVIS Ruth Joanna; BARTA Imre; AZZINI Anna Maria; ASKLING Helena H; ARGYROPOULOS Christos D; ALVAREZ-BARCO Elena; AKOVA Murat; BONTEN Marc M J; COHEN-KANDLI Miriam; COX Rebecca Jane; FLISIAK Robert; HUSA Petr; JANCORIENE Ligita; KOSCALOVA Alena; LAUNAY Odile; LUNDGREN Jens; MALLON Patrick; MARQUES Laura; NAUCLER Pontus; OCHANDO Jordi; PANA Zoi-Dorothea; TACCONELLI Evelina; TOTH Krisztina; TRELLE Sven; PIERRE van Damme; ZAOUTIS Theoklis E; ZEITLINGER Markus; ALBUS Kerstin; STEWART Fiona A; HOFSTRAAT Sanne H I; BRUIJNING-VERHAGEN Patricia; CORNELY Oliver A
• Year of publication: 2023
• Type: Article in Periodical
• Magazine / Source: Vaccine
• MU Faculty or unit: Faculty of Medicine
• Web: https://www.sciencedirect.com/science/article/pii/S0264410X23005236?via%3Dihub
• Doi: http://dx.doi.org/10.1016/j.vaccine.2023.05.006
• Keywords: SARS-CoV-2; Registry; Pandemic preparedness; Vaccine trial; Site; Clinical network
• Description: Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experi-ence, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clin-ical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study char-acteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selec-tion process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppres-sion by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in sev-eral indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interven-tional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxovindae/in-fluenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe. & COPY; 2023 The Authors. Published by Elsevier Ltd.