Vaccines (Nov 2023)
The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium
- Dimitrios Poulimeneas,
- Markela Koniordou,
- Dimitra Kousi,
- Christina Merakou,
- Ioannis Kopsidas,
- Grammatiki Christina Tsopela,
- Christos D. Argyropoulos,
- Sophia C. Themistocleous,
- George Shiamakkides,
- Marinos Constantinou,
- Alexandra Alexandrou,
- Evgenia Noula,
- Andria Nearchou,
- Jon Salmanton-García,
- Fiona A. Stewart,
- Sarah Heringer,
- Kerstin Albus,
- Elena Álvarez-Barco,
- Alan Macken,
- Romina Di Marzo,
- Catarina Luis,
- Paula Valle-Simón,
- Helena H. Askling,
- Margot Hellemans,
- Orly Spivak,
- Ruth Joanna Davis,
- Anna Maria Azzini,
- Imre Barta,
- Lenka Součková,
- Ligita Jancoriene,
- Murat Akova,
- Patrick W. G. Mallon,
- Ole F. Olesen,
- Jesus Frias-Iniesta,
- Pierre van Damme,
- Krisztina Tóth,
- Miriam Cohen-Kandli,
- Rebecca Jane Cox,
- Petr Husa,
- Pontus Nauclér,
- Laura Marques,
- Jordi Ochando,
- Evelina Tacconelli,
- Markus Zeitlinger,
- Oliver A. Cornely,
- Zoi Dorothea Pana,
- Theoklis E. Zaoutis
Affiliations
- Dimitrios Poulimeneas
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Markela Koniordou
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Dimitra Kousi
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Christina Merakou
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Ioannis Kopsidas
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Grammatiki Christina Tsopela
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- Christos D. Argyropoulos
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Sophia C. Themistocleous
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- George Shiamakkides
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Marinos Constantinou
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Alexandra Alexandrou
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Evgenia Noula
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Andria Nearchou
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Jon Salmanton-García
- Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Institute of Translational Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany
- Fiona A. Stewart
- Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Institute of Translational Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany
- Sarah Heringer
- Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Institute of Translational Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany
- Kerstin Albus
- Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Institute of Translational Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany
- Elena Álvarez-Barco
- Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland
- Alan Macken
- Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland
- Romina Di Marzo
- European Vaccine Initiative (EVI), 69115 Heidelberg, Germany
- Catarina Luis
- European Vaccine Initiative (EVI), 69115 Heidelberg, Germany
- Paula Valle-Simón
- Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain
- Helena H. Askling
- Department of Infectious Diseases, Karolinska University Hospital, 17177 Stockholm, Sweden
- Margot Hellemans
- VAXINFECTIO, Centre of Evaluation of Vaccination, Faculty of Medicine and Health Science, Universiteit Antwerpen, 2610 Antwerp, Belgium
- Orly Spivak
- Ministry of Health of Israel, Jerusalem 1176, Israel
- Ruth Joanna Davis
- Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy
- Anna Maria Azzini
- Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy
- Imre Barta
- National Koranyi Institute for Pulmonology, 1121 Budapest, Hungary
- Lenka Součková
- Department of Pharmacology, Faculty of Medicine, Masaryk University, 60177 Brno, Czech Republic
- Ligita Jancoriene
- Institute of Clinical Medicine, Medical Faculty, Vilnius University, 03101 Vilnius, Lithuania
- Murat Akova
- Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Haceteppe University, Ankara 06230, Turkey
- Patrick W. G. Mallon
- Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland
- Ole F. Olesen
- European Vaccine Initiative (EVI), 69115 Heidelberg, Germany
- Jesus Frias-Iniesta
- Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain
- Pierre van Damme
- VAXINFECTIO, Centre of Evaluation of Vaccination, Faculty of Medicine and Health Science, Universiteit Antwerpen, 2610 Antwerp, Belgium
- Krisztina Tóth
- National Koranyi Institute for Pulmonology, 1121 Budapest, Hungary
- Miriam Cohen-Kandli
- Ministry of Health of Israel, Jerusalem 1176, Israel
- Rebecca Jane Cox
- Influenza Centre, Department of Clinical Science, University of Bergen, 5020 Bergen, Norway
- Petr Husa
- Department of Pharmacology, Faculty of Medicine, Masaryk University, 60177 Brno, Czech Republic
- Pontus Nauclér
- Department of Infectious Diseases, Karolinska University Hospital, 17177 Stockholm, Sweden
- Laura Marques
- Centro Hospitalar Universitário do Porto, 4099-001 Porto, Portugal
- Jordi Ochando
- Centro Nacional de Microbiología, Instituto de Salud Carlos III, 28220 Madrid, Spain
- Evelina Tacconelli
- Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy
- Markus Zeitlinger
- Department of Clinical Pharmacology, Medical University Vienna, 1090 Vienna, Austria
- Oliver A. Cornely
- Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Institute of Translational Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany
- Zoi Dorothea Pana
- School of Medicine, European University Cyprus, Nicosia 2404, Cyprus
- Theoklis E. Zaoutis
- Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece
- DOI
- https://doi.org/10.3390/vaccines11121784
- Journal volume & issue
-
Vol. 11,
no. 12
p. 1784
Abstract
Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey. From 15 eligible groups, those that were more frequently declared underserved/hard-to-reach in vaccine research were ethnic minorities (76.5%), persons experiencing homelessness (70.6%), illegal workers and refugees (64.7%, each). When prioritization for education on vaccine trials was considered, ethnic groups, migrants, and immigrants (5/17, 29.4%) were the groups most frequently identified by the NC as top targets. The most prominent barriers in vaccine trial participation affecting all groups were low levels of health literacy, reluctance to participate in trials due to engagement level, and low levels of trust in vaccines/vaccinations. This study highlighted population groups considered underserved/hard-to-reach in countries contained within the European region, and the respective barriers these groups face when participating in clinical studies. Our findings aid with the design of tailored interventions (within—and across—countries of the European region) and with the development of strategies to overcome major barriers in phase 2 and phase 3 vaccine trial participation.
Keywords