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VACCELERATE Volunteer Registry: A European study participant database to facilitate clinical trial enrolment

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SALMANTON-GARCIA Jon STEWART Fiona A HERINGER Sarah KONIORDOU Markela ALVAREZ-BARCO Elena ARGYROPOULOS Christos D THEMISTOCLEOUS Sophia C VALLE-SIMON Paula SPIVAK Orly SOUČKOVÁ Lenka MERAKOU Christina MENDONCA Maria Amelia DAVIS Ruth Joanna AZZINI Anna Maria ASKLING Helena H VENE Sirkka PIERRE Van Damme STEINBACH Angela SHIAMAKKIDES George SEIDEL Danila OLESEN Ole F NOULA Evgenia MACKEN Alan LUIS Catarina LECKLER Janina LAUNAY Odile ISITT Catherine HELLEMANS Margot FRIAS-INIESTA Jesus ROMINA Di Marzo CARCAS Antonio J BOUSTRAS George BOROBIA Alberto M BARTA Imre ALBUS Kerstin AKOVA Murat OCHANDO Jordi COHEN-KANDLI Miriam COX Rebecca Jane HUSA Petr JANCORIENE Ligita MALLON Patrick MARQUES Laura MELLINGHOFF Sibylle C NAUCLER Pontus TACCONELLI Evelina TOTH Krisztina ZAOUTIS Theoklis E ZEITLINGER Markus CORNELY Oliver A PANA Zoi-Dorothea

Rok publikování 2022
Druh Článek v odborném periodiku
Časopis / Zdroj Vaccine
Fakulta / Pracoviště MU

Lékařská fakulta

Citace
www https://www.sciencedirect.com/science/article/pii/S0264410X22006053?via%3Dihub
Doi http://dx.doi.org/10.1016/j.vaccine.2022.05.022
Klíčová slova SARS-CoV-2; Registry; Pandemic preparedness; Clinical trial; Volunteer; Vaccination campaign; COVID-19; Vaccination network
Popis Introduction: The coronavirus disease 2019 (COVID-19) pandemic has evidenced the key role of vaccine design, obtention, production and administration to successfully fight against infectious diseases and to provide efficient remedies for the citizens. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE's Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. Methods: Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry. Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements. Results: As of May 2022, the questionnaire is available in 12 countries and 14 languages. Up to date, more than 36,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched more than 15,000 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months. Conclusions: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 12 countries (i.e., Austria, Cyprus, Germany, Greece, Ireland, Lithuania, Norway, Portugal, Spain, Sweden and Turkey). To date, more than 15,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 5 additional countries (i.e., Belgium, Czech Republic, Hungary, Israel and the Netherlands).
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