The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium

Author:

Poulimeneas Dimitrios1,Koniordou Markela1ORCID,Kousi Dimitra1,Merakou Christina1ORCID,Kopsidas Ioannis1ORCID,Tsopela Grammatiki Christina1,Argyropoulos Christos D.2ORCID,Themistocleous Sophia C.2,Shiamakkides George2,Constantinou Marinos2,Alexandrou Alexandra2,Noula Evgenia2,Nearchou Andria2,Salmanton-García Jon345ORCID,Stewart Fiona A.34ORCID,Heringer Sarah345ORCID,Albus Kerstin35ORCID,Álvarez-Barco Elena6,Macken Alan6ORCID,Di Marzo Romina7ORCID,Luis Catarina7,Valle-Simón Paula89,Askling Helena H.1011,Hellemans Margot12ORCID,Spivak Orly13,Davis Ruth Joanna14,Azzini Anna Maria14ORCID,Barta Imre15ORCID,Součková Lenka161718,Jancoriene Ligita1920ORCID,Akova Murat21ORCID,Mallon Patrick W. G.6,Olesen Ole F.7ORCID,Frias-Iniesta Jesus89,van Damme Pierre12,Tóth Krisztina15,Cohen-Kandli Miriam13,Cox Rebecca Jane22ORCID,Husa Petr161718ORCID,Nauclér Pontus1011,Marques Laura23,Ochando Jordi24,Tacconelli Evelina14,Zeitlinger Markus25,Cornely Oliver A.3452627ORCID,Pana Zoi Dorothea2,Zaoutis Theoklis E.128

Affiliation:

1. Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece

2. School of Medicine, European University Cyprus, Nicosia 2404, Cyprus

3. 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

4. German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne, 38124 Cologne, Germany

5. Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany

6. Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland

7. European Vaccine Initiative (EVI), 69115 Heidelberg, Germany

8. Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain

9. Servicio Madrileño de Salud, 28046 Madrid, Spain

10. Department of Infectious Diseases, Karolinska University Hospital, 17177 Stockholm, Sweden

11. Department of Medicine, Division of Infectious Diseases, Karolinska Institutet, 17177 Stockholm, Sweden

12. VAXINFECTIO, Centre of Evaluation of Vaccination, Faculty of Medicine and Health Science, Universiteit Antwerpen, 2610 Antwerp, Belgium

13. Ministry of Health of Israel, Jerusalem 1176, Israel

14. Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy

15. National Koranyi Institute for Pulmonology, 1121 Budapest, Hungary

16. Department of Pharmacology, Faculty of Medicine, Masaryk University, 60177 Brno, Czech Republic

17. University Hospital Brno, 62500 Brno, Czech Republic

18. Czech Clinical Research Infrastructure Network (CZECRIN), 62500 Brno, Czech Republic

19. Institute of Clinical Medicine, Medical Faculty, Vilnius University, 03101 Vilnius, Lithuania

20. Vilnius University Hospital Santaros Klinikos, Medical Faculty, Vilnius University, 03101 Vilnius, Lithuania

21. Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Haceteppe University, Ankara 06230, Turkey

22. Influenza Centre, Department of Clinical Science, University of Bergen, 5020 Bergen, Norway

23. Centro Hospitalar Universitário do Porto, 4099-001 Porto, Portugal

24. Centro Nacional de Microbiología, Instituto de Salud Carlos III, 28220 Madrid, Spain

25. Department of Clinical Pharmacology, Medical University Vienna, 1090 Vienna, Austria

26. Clinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany

27. Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany

28. 2nd Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens, 11527 Athens, Greece

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.

Funder

European Union’s Horizon 2020 Research and Innovation Programme

Publisher

MDPI AG

Subject

Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology

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