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VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment

28 Pages Posted: 24 Jan 2022

See all articles by Jon Salmanton-Garcia

Jon Salmanton-Garcia

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Fiona Anne Stewart

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Sarah Heringer

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Markela Koniordou

affiliation not provided to SSRN

Elena Álvarez-Barco

affiliation not provided to SSRN

Christos D. Argyropoulos

European University Cyprus

Sophia C. Themistolcleous

affiliation not provided to SSRN

Paula Valle-Simón

affiliation not provided to SSRN

Orly Spivak

affiliation not provided to SSRN

Lenka Součková

affiliation not provided to SSRN

Christina Merakou

affiliation not provided to SSRN

Maria Amélia Mendonça

affiliation not provided to SSRN

Ruth Joanna Davis

affiliation not provided to SSRN

Anna Maria Azzini

affiliation not provided to SSRN

Helena H. Askling

affiliation not provided to SSRN

Sirkka Vene

affiliation not provided to SSRN

Pierre Van Damme

University of Antwerp - Vaccine and Infectious Disease Institute

Angela Steinbach

affiliation not provided to SSRN

George Shiamakkides

European University Cyprus

Danila Seidel

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Ole F. Olesen

affiliation not provided to SSRN

Evgenia Noula

European University Cyprus

Alan Macken

affiliation not provided to SSRN

Catarina Luís

affiliation not provided to SSRN

Janina Leckler

affiliation not provided to SSRN

Odile Launay

Assistance Publique-Hôpitaux de Paris - Clinical Investigation Center (CIC 1417)

Catherine Isitt

affiliation not provided to SSRN

Margot Hellemans

affiliation not provided to SSRN

Jesús Frias-Iniesta

affiliation not provided to SSRN

Romina Di Marzo

affiliation not provided to SSRN

Antonio J Carcas

La Paz University Hospital - Servicio de Farmacología Clínica

George Boustras

affiliation not provided to SSRN

Alberto M Borobia

La Paz University Hospital - Servicio de Farmacología Clínica

Imre Barta

affiliation not provided to SSRN

Kerstin Albus

affiliation not provided to SSRN

Murat Akova

affiliation not provided to SSRN

Jordi Ochando

Carlos III Institute of Health - Laboratorio de Referencia en Inmunología

Miriam Cohen-Kandli

affiliation not provided to SSRN

Rebecca Jane Cox

affiliation not provided to SSRN

Petr Husa

affiliation not provided to SSRN

Ligita Jancoriene

Vilnius University

Patrick Mallon

affiliation not provided to SSRN

Laura Marques

affiliation not provided to SSRN

Sibylle C. Mellinghoff

affiliation not provided to SSRN

Pontus Nauclér

Karolinska Institutet - Division of Infectious Diseases

Evelina Tacconelli

University of Verona - Infectious Diseases, Department of Diagnostic and Public Health

Krisztina Beer-Tóth

affiliation not provided to SSRN

Theoklis E. Zaoutis

affiliation not provided to SSRN

Markus Zeitlinger

Medical University of Vienna - Department of Clinical Pharmacology

Oliver A. Cornely

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Zoi-Dorothea Pana

European University Cyprus - School of Medicine

the VACCELERATE consortium

affiliation not provided to SSRN

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Multiple version iconThere are 2 versions of this paper

Abstract

Background: The coronavirus disease 2019 (COVID-19) pandemic has demonstrated the key role that vaccines play against infectious diseases. 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.

Findings: As of January 2022, the questionnaire is available in 9 countries and 11 languages. Up to date, more than 35,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched 13,719 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months.

Interpretation: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 9 countries. To date, more than 13,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 6 additional countries.

Funding: The German Volunteer Registry receives funding from the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) specifically grant BMBF01KX2040. The VACCELERATE Volunteer Registry, i.e., registries outside Germany, has received funding from the European Union’s Horizon 2020 research and innovation programme (grant agreement No 101037867).

Declaration of Interest: None to declare.

Ethical Approval: The VACCELERATE Volunteer Registry was approved by the Ethics Committee of the Medical Faculty of the University of Cologne (Cologne, Germany) (Study 20-1536).

Suggested Citation

Salmanton-Garcia, Jon and Stewart, Fiona Anne and Heringer, Sarah and Koniordou, Markela and Álvarez-Barco, Elena and Argyropoulos, Christos D. and Themistolcleous, Sophia C. and Valle-Simón, Paula and Spivak, Orly and Součková, Lenka and Merakou, Christina and Mendonça, Maria Amélia and Davis, Ruth Joanna and Azzini, Anna Maria and Askling, Helena H. and Vene, Sirkka and Van Damme, Pierre and Steinbach, Angela and Shiamakkides, George and Seidel, Danila and Olesen, Ole F. and Noula, Evgenia and Macken, Alan and Luís, Catarina and Leckler, Janina and Launay, Odile and Isitt, Catherine and Hellemans, Margot and Frias-Iniesta, Jesús and Di Marzo, Romina and Carcas, Antonio J and Boustras, George and Borobia, Alberto M and Barta, Imre and Albus, Kerstin and Akova, Murat and Ochando, Jordi and Cohen-Kandli, Miriam and Cox, Rebecca Jane and Husa, Petr and Jancoriene, Ligita and Mallon, Patrick and Marques, Laura and Mellinghoff, Sibylle C. and Nauclér, Pontus and Tacconelli, Evelina and Beer-Tóth, Krisztina and Zaoutis, Theoklis E. and Zeitlinger, Markus and Cornely, Oliver A. and Pana, Zoi-Dorothea and consortium, the VACCELERATE, VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment (1/19/2022). Available at SSRN: https://ssrn.com/abstract=4016606 or http://dx.doi.org/10.2139/ssrn.4016606

Jon Salmanton-Garcia

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD) ( email )

Fiona Anne Stewart

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD) ( email )

Sarah Heringer

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD) ( email )

Markela Koniordou

affiliation not provided to SSRN ( email )

No Address Available

Elena Álvarez-Barco

affiliation not provided to SSRN ( email )

No Address Available

Christos D. Argyropoulos

European University Cyprus ( email )

6 Diogenes Street, Engomi
Nicosia, 1516
Cyprus

Sophia C. Themistolcleous

affiliation not provided to SSRN

Paula Valle-Simón

affiliation not provided to SSRN ( email )

No Address Available

Orly Spivak

affiliation not provided to SSRN ( email )

No Address Available

Lenka Součková

affiliation not provided to SSRN ( email )

No Address Available

Christina Merakou

affiliation not provided to SSRN ( email )

No Address Available

Maria Amélia Mendonça

affiliation not provided to SSRN ( email )

No Address Available

Ruth Joanna Davis

affiliation not provided to SSRN ( email )

No Address Available

Anna Maria Azzini

affiliation not provided to SSRN ( email )

No Address Available

Helena H. Askling

affiliation not provided to SSRN ( email )

No Address Available

Sirkka Vene

affiliation not provided to SSRN ( email )

No Address Available

Pierre Van Damme

University of Antwerp - Vaccine and Infectious Disease Institute ( email )

Belgium

Angela Steinbach

affiliation not provided to SSRN ( email )

No Address Available

George Shiamakkides

European University Cyprus ( email )

6 Diogenes Street, Engomi
Nicosia, 1516
Cyprus

Danila Seidel

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD)

Albertus-Magnus-Platz
Cologne, 50923
Germany

Ole F. Olesen

affiliation not provided to SSRN ( email )

No Address Available

Evgenia Noula

European University Cyprus ( email )

6 Diogenes Street, Engomi
Nicosia, 1516
Cyprus

Alan Macken

affiliation not provided to SSRN ( email )

No Address Available

Catarina Luís

affiliation not provided to SSRN ( email )

No Address Available

Janina Leckler

affiliation not provided to SSRN ( email )

No Address Available

Odile Launay

Assistance Publique-Hôpitaux de Paris - Clinical Investigation Center (CIC 1417) ( email )

Paris
France

Catherine Isitt

affiliation not provided to SSRN ( email )

No Address Available

Margot Hellemans

affiliation not provided to SSRN ( email )

No Address Available

Jesús Frias-Iniesta

affiliation not provided to SSRN

Romina Di Marzo

affiliation not provided to SSRN

Antonio J Carcas

La Paz University Hospital - Servicio de Farmacología Clínica ( email )

Madrid
Spain

George Boustras

affiliation not provided to SSRN

Alberto M Borobia

La Paz University Hospital - Servicio de Farmacología Clínica ( email )

Madrid
Spain

Imre Barta

affiliation not provided to SSRN

No Address Available

Kerstin Albus

affiliation not provided to SSRN ( email )

No Address Available

Murat Akova

affiliation not provided to SSRN

Jordi Ochando

Carlos III Institute of Health - Laboratorio de Referencia en Inmunología

c/ Monforte de Lemos 5
Madrid, Madrid 28029
Spain

Miriam Cohen-Kandli

affiliation not provided to SSRN ( email )

No Address Available

Rebecca Jane Cox

affiliation not provided to SSRN

Petr Husa

affiliation not provided to SSRN ( email )

No Address Available

Ligita Jancoriene

Vilnius University ( email )

Patrick Mallon

affiliation not provided to SSRN

Laura Marques

affiliation not provided to SSRN ( email )

No Address Available

Sibylle C. Mellinghoff

affiliation not provided to SSRN

Pontus Nauclér

Karolinska Institutet - Division of Infectious Diseases ( email )

Evelina Tacconelli

University of Verona - Infectious Diseases, Department of Diagnostic and Public Health ( email )

Krisztina Beer-Tóth

affiliation not provided to SSRN

Theoklis E. Zaoutis

affiliation not provided to SSRN ( email )

No Address Available

Markus Zeitlinger

Medical University of Vienna - Department of Clinical Pharmacology ( email )

Oliver A. Cornely (Contact Author)

University of Cologne - Cluster of Excellence Cellular Stress Responses in Aging-Associated Diseases (CECAD) ( email )

Zoi-Dorothea Pana

European University Cyprus - School of Medicine ( email )

The VACCELERATE Consortium

affiliation not provided to SSRN ( email )

No Address Available