TY - JOUR
T1 - VACCELERATE Site Network
T2 - Real-time definition of clinical study capacity in Europe
AU - Salmanton-García, Jon
AU - Wipfler, Pauline
AU - Valle-Simón, Paula
AU - Merakou, Christina
AU - Kopsidas, Ioannis
AU - Bethe, Ullrich
AU - Steinbach, Angela
AU - Spivak, Orly
AU - Součková, Lenka
AU - Mendonça, Maria Amélia
AU - Koniordou, Markela
AU - Hellemans, Margot
AU - Frías-Iniesta, Jesus
AU - Davis, Ruth Joanna
AU - Barta, Imre
AU - Azzini, Anna Maria
AU - Askling, Helena H
AU - Argyropoulos, Christos D
AU - Álvarez-Barco, Elena
AU - Akova, Murat
AU - Bonten, Marc M J
AU - Cohen-Kandli, Miriam
AU - Cox, Rebecca Jane
AU - Flisiak, Robert
AU - Husa, Petr
AU - Jancoriene, Ligita
AU - Koscalova, Alena
AU - Launay, Odile
AU - Lundgren, Jens
AU - Mallon, Patrick
AU - Marques, Laura
AU - Nauclér, Pontus
AU - Ochando, Jordi
AU - Pana, Zoi-Dorothea
AU - Tacconelli, Evelina
AU - Tóth, Krisztina
AU - Trelle, Sven
AU - van Damme, Pierre
AU - Zaoutis, Theoklis E
AU - Zeitlinger, Markus
AU - Albus, Kerstin
AU - Stewart, Fiona A
AU - Hofstraat, Sanne H I
AU - Bruijning-Verhagen, Patricia
AU - Cornely, Oliver A
N1 - Funding Information:
The VACCELERATE Site Network has received funding from the European Union’s Horizon 2020 research and innovation programme (grant agreement No 101037867 ) and the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (grant agreement No BMBF01KX2040 ).
Funding Information:
The VACCELERATE Site Network has received funding from the European Union's Horizon 2020 research and innovation programme (grant agreement No 101037867) and the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (grant agreement No BMBF01KX2040).
Publisher Copyright:
© 2023 The Authors
PY - 2023/6/13
Y1 - 2023/6/13
N2 - 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.
AB - 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.
KW - Clinical network
KW - Pandemic preparedness
KW - Registry
KW - SARS-CoV-2
KW - Site
KW - Vaccine trial
UR - http://www.scopus.com/inward/record.url?scp=85160048585&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2023.05.006
DO - 10.1016/j.vaccine.2023.05.006
M3 - Article
C2 - 37210309
SN - 0264-410X
VL - 41
SP - 3915
EP - 3922
JO - Vaccine
JF - Vaccine
IS - 26
ER -