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VACCELERATE volunteer registry: a European study participant database to facilitate clinical trial enrolment

Salmanton-García J, Stewart FA, Heringer S, Koniordou M, Álvarez-Barco E, Argyropoulos CD, Themistocleous SC, Valle-Simón P, Spivak O, Součková L, Merakou C, Amélia Mendonça M, Joanna Davis R, Maria Azzini A, Askling HH, Vene S, Van Damme P, Steinbach A, Shiamakkides G, Seidel D, Olesen OF, Noula E, Macken A, Luís C, Leckler J, Launay O, Isitt C, Hellemans M, Frías-Iniesta J, Di Marzo R, Carcas AJ, Boustras G, Borobia AM, Barta I, Albus K, Akova M, Ochando J, Cohen-Kandli M, Jane Cox R, Husa P, Jancoriene L, Mallon P, Marques L, Mellinghoff SC, Nauclér P, Tacconelli E, Tóth K, Zaoutis TE, Zeitlinger M, Cornely OA, Pana ZD; VACCELERATE consortium. VACCELERATE Volunteer Registry

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 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).

Keywords: COVID-19; Clinical trial; Pandemic preparedness; Registry; SARS-CoV-2; Vaccination campaign; Vaccination network; Volunteer.

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