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

. 2023 Jun 13 ; 41 (26) : 3915-3922. [epub] 20230518

Jazyk angličtina Země Nizozemsko Médium print-electronic

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid37210309
Odkazy

PubMed 37210309
PubMed Central PMC10194816
DOI 10.1016/j.vaccine.2023.05.006
PII: S0264-410X(23)00523-6
Knihovny.cz E-zdroje

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 experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical 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 characteristics 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 selection 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 immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several 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 interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza 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.

Biomedical Research Center of the Slovak Academy of Sciences Bratislava Slovakia

Centre of Excellence for Health Immunity and Infections Rigshospitalet Copenhagen Denmark

Centro Hospitalar Universitário do Porto Porto Portugal

Centro Nacional de Microbiologia Instituto de Salud Carlos 3 Madrid Spain

Collaborative Center for Clinical Epidemiology and Outcomes Research Athens Greece

Department of Infectious Diseases and Hepatology Medical University of Bialystok Białystok Poland

European University of Cyprus Nicosia Republic of Cyprus

Haceteppe University Ankara Turkey

Hospital La Paz Institute for Health Research Madrid Spain; Servicio Madrileño de Salud Madrid Spain

Institut National de la Santé et de la Recherche Médicale ANRS Maladies Infectieuses Émergentes Paris France

Institute of Clinical Medicine Medical Faculty Vilnius University Vilnius University Hospital Santaros klinikos Vilnius Lithuania

Julius Center for Health Sciences and Primary Care University Medical Centre Utrecht Utrecht University Utrecht Netherlands; Department of Medical Microbiology University Medical Centre Utrecht Utrecht Netherlands

Karolinska University Hospital Stockholm Sweden

Masaryk University Brno Czech Republic

Medizinische Universität Wien Vienna Austria

Ministry of Health of Israel Jerusalem Israel

National Koranyi Institute for Pulmonology Budapest Hungary

Universitaet Bern Bern Switzerland

Universiteit Antwerpen Faculty of Medicine and Health Science VAXINFECTIO Centre of Evaluation of Vaccination Antwerp Belgium

University College Dublin National University of Ireland Dublin Ireland

University Medical Centre Utrecht Utrecht University Utrecht Netherlands

University of Bergen Bergen Norway

University of Cologne Faculty of Medicine and University Hospital Cologne Institute of Translational Research Cologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases Cologne Germany

University of Cologne Faculty of Medicine and University Hospital Cologne Institute of Translational Research Cologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases Partner Site Bonn Cologne Cologne Germany

University of Verona Infectious Diseases Division Department of Diagnostic and Public Health Verona Italy

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