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

Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Poulimeneas, Dimitrios;
ORCID
0000-0002-6034-1291
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Koniordou, Markela;
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Kousi, Dimitra;
ORCID
0000-0002-2098-599X
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Merakou, Christina;
ORCID
0000-0001-6499-4807
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Kopsidas, Ioannis;
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Tsopela, Grammatiki Christina;
ORCID
0000-0002-2090-2162
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Argyropoulos, Christos D.;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Themistocleous, Sophia C.;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Shiamakkides, George;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Constantinou, Marinos;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Alexandrou, Alexandra;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Noula, Evgenia;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Nearchou, Andria;
ORCID
0000-0002-6766-8297
Affiliation
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;(J.S.-G.);(S.H.);(O.A.C.)
Salmanton-García, Jon;
ORCID
0000-0002-1029-5768
Affiliation
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;(J.S.-G.);(S.H.);(O.A.C.)
Stewart, Fiona A.;
ORCID
0000-0001-7680-0344
Affiliation
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;(J.S.-G.);(S.H.);(O.A.C.)
Heringer, Sarah;
ORCID
0000-0003-1124-4310
Affiliation
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;(J.S.-G.);(S.H.);(O.A.C.)
Albus, Kerstin;
Affiliation
Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland;(E.Á.-B.);(A.M.);(P.W.G.M.)
Álvarez-Barco, Elena;
ORCID
0000-0003-3320-8767
Affiliation
Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland;(E.Á.-B.);(A.M.);(P.W.G.M.)
Macken, Alan;
ORCID
0000-0002-8715-0348
Affiliation
European Vaccine Initiative (EVI), 69115 Heidelberg, Germany;(R.D.M.);(C.L.);(O.F.O.)
Di Marzo, Romina;
Affiliation
European Vaccine Initiative (EVI), 69115 Heidelberg, Germany;(R.D.M.);(C.L.);(O.F.O.)
Luis, Catarina;
Affiliation
Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain;(P.V.-S.);(J.F.-I.)
Valle-Simón, Paula;
Affiliation
Department of Infectious Diseases, Karolinska University Hospital, 17177 Stockholm, Sweden;(H.H.A.);(P.N.)
Askling, Helena H.;
ORCID
0009-0005-2926-1559
Affiliation
VAXINFECTIO, Centre of Evaluation of Vaccination, Faculty of Medicine and Health Science, Universiteit Antwerpen, 2610 Antwerp, Belgium;(M.H.);(P.v.D.)
Hellemans, Margot;
Affiliation
Ministry of Health of Israel, Jerusalem 1176, Israel;(O.S.);(M.C.-K.)
Spivak, Orly;
Affiliation
Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy;(R.J.D.);(A.M.A.);(E.T.)
Davis, Ruth Joanna;
ORCID
0000-0002-7148-2559
Affiliation
Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy;(R.J.D.);(A.M.A.);(E.T.)
Azzini, Anna Maria;
ORCID
0000-0003-0067-5166
Affiliation
National Koranyi Institute for Pulmonology, 1121 Budapest, Hungary(K.T.)
Barta, Imre;
Affiliation
Department of Pharmacology, Faculty of Medicine, Masaryk University, 60177 Brno, Czech Republic;(L.S.);(P.H.)
Součková, Lenka;
ORCID
0000-0001-6488-6312
Affiliation
Institute of Clinical Medicine, Medical Faculty, Vilnius University, 03101 Vilnius, Lithuania;
Jancoriene, Ligita;
ORCID
0000-0002-6904-9473
Affiliation
Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Haceteppe University, Ankara 06230, Turkey;
Akova, Murat;
Affiliation
Centre for Experimental Pathogen Host Research, School of Medicine, University College Dublin, D04 V1W8 Dublin, Ireland;(E.Á.-B.);(A.M.);(P.W.G.M.)
Mallon, Patrick W. G.;
ORCID
0000-0002-3025-2466
Affiliation
European Vaccine Initiative (EVI), 69115 Heidelberg, Germany;(R.D.M.);(C.L.);(O.F.O.)
Olesen, Ole F.;
Affiliation
Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain;(P.V.-S.);(J.F.-I.)
Frias-Iniesta, Jesus;
Affiliation
VAXINFECTIO, Centre of Evaluation of Vaccination, Faculty of Medicine and Health Science, Universiteit Antwerpen, 2610 Antwerp, Belgium;(M.H.);(P.v.D.)
van Damme, Pierre;
Affiliation
National Koranyi Institute for Pulmonology, 1121 Budapest, Hungary(K.T.)
Tóth, Krisztina;
Affiliation
Ministry of Health of Israel, Jerusalem 1176, Israel;(O.S.);(M.C.-K.)
Cohen-Kandli, Miriam;
ORCID
0000-0002-8341-4078
Affiliation
Influenza Centre, Department of Clinical Science, University of Bergen, 5020 Bergen, Norway;
Cox, Rebecca Jane;
ORCID
0000-0002-9190-2610
Affiliation
Department of Pharmacology, Faculty of Medicine, Masaryk University, 60177 Brno, Czech Republic;(L.S.);(P.H.)
Husa, Petr;
Affiliation
Department of Infectious Diseases, Karolinska University Hospital, 17177 Stockholm, Sweden;(H.H.A.);(P.N.)
Nauclér, Pontus;
Affiliation
Centro Hospitalar Universitário do Porto, 4099-001 Porto, Portugal;
Marques, Laura;
Affiliation
Centro Nacional de Microbiología, Instituto de Salud Carlos III, 28220 Madrid, Spain;
Ochando, Jordi;
Affiliation
Infectious Diseases, Department of Diagnostic and Public Health, University of Verona, 37134 Verona, Italy;(R.J.D.);(A.M.A.);(E.T.)
Tacconelli, Evelina;
Affiliation
Department of Clinical Pharmacology, Medical University Vienna, 1090 Vienna, Austria;
Zeitlinger, Markus;
ORCID
0000-0001-9599-3137
Affiliation
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;(J.S.-G.);(S.H.);(O.A.C.)
Cornely, Oliver A.;
Affiliation
School of Medicine, European University Cyprus, Nicosia 2404, Cyprus;(C.D.A.);(S.C.T.);(M.C.);(A.A.);(E.N.);(A.N.);(Z.D.P.)
Pana, Zoi Dorothea;
Affiliation
Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), 15451 Athens, Greece;(D.P.);(M.K.);(D.K.);(C.M.);(G.C.T.)
Zaoutis, Theoklis E.

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.

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