BACKGROUND: The pan-European VACCELERATE network aims to implement the first transnational harmonized and sustainable vaccine trial Volunteer Registry, being a single entry point for potential volunteers of large-scale vaccine trials across Europe. This work exhibits a set of harmonized vaccine trial-related educational and promotional tools for the general public, designed and disseminated by the pan-European VACCELERATE network. OBJECTIVE: This study primarily aimed to design and develop a standard toolkit to increase positive attitudes and access to trustworthy information for better access and increased recruitment to vaccine trials for the public. More specifically, the produced tools are focused on inclusiveness and equity, and are targeting different population groups, including underserved ones, as potential volunteers for the VACCELERATE Volunteer Registry (older individuals, migrants, children, and adolescents). The promotional and educational material is aligned with the main objectives of the Volunteer Registry to increase public literacy and awareness regarding vaccine-related clinical research or trials and trial participation, including informed consent and legal issues, side effects, and frequently asked questions regarding vaccine trial design. METHODS: Tools were developed per the aims and principles of the VACCELERATE project, focusing on trial inclusiveness and equity, and are adjusted to local country-wise requirements to improve public health communication. The produced tools are selected based on the cognitive theory, inclusiveness, and equity of differently aged and underrepresented groups, and standardized material from several official trustworthy sources (eg, COVID-19 Vaccines Global Access; the European Centre for Disease Prevention and Control; the European Patients' Academy on Therapeutic Innovation; Gavi, the Vaccine Alliance; and the World Health Organization). A team of multidisciplinary specialists (infectious diseases, vaccine research, medicine, and education) edited and reviewed the subtitles and scripts of the educational videos, extended brochures, interactive cards, and puzzles. Graphic designers selected the color palette, audio settings, and dubbing for the video story-tales and implemented QR codes. RESULTS: This study presents the first set of harmonized promotional and educational materials and tools (ie, educational cards, educational and promotional videos, extended brochures, flyers, posters, and puzzles) for vaccine clinical research (eg, COVID-19 vaccines). These tools inform the public about possible benefits and disadvantages of trial participation and build confidence among participants about the safety and efficacy of COVID-19 vaccines and the health care system. This material has been translated into several languages and is intended to be freely and easily accessible to facilitate dissemination among VACCELERATE network participant countries and the European and global scientific, industrial, and public community. CONCLUSIONS: The produced material could help fill knowledge gaps of health care personnel, providing the appropriate future patient education for vaccine trials, and tackling vaccine hesitancy and parents' concerns for potential participation of children in vaccine trials.

Assistance Publique Hopitaux de Paris Université Paris Cité Paris France

Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Center for Medical Mycology Department 1 of Internal Medicine Faculty of Medicine and University Hospital Cologne University of Cologne Cologne Germany

Center for Molecular Medicine Cologne Faculty of Medicine and University Hospital Cologne University of Cologne Cologne Germany

Centre for Experimental Pathogen Host Research School of Medicine University College Dublin Dublin Ireland

Centre of Excellence for Health Immunity and Infections Rigshospitalet University of Copenhagen Copenhagen Denmark

Centro Hospitalar Universitário do Porto Porto Portugal

Centro Nacional de Microbiología Instituto de Salud Carlos 3 Madrid Spain

Clinical Trials Centre Cologne Faculty of Medicine and University Hospital Cologne University of Cologne Cologne Germany

Collaborative Center for Clinical Epidemiology and Outcomes Research Athens Greece

Cologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases Faculty of Medicine and University Hospital Cologne University of Cologne Cologne Germany

Czech Clinical Research Infrastructure Network Brno Czech Republic

Department of Infectious Diseases and Clinical Microbiology Faculty of Medicine Haceteppe University Ankara Turkey

Department of Infectious Diseases Karolinska University Hospital Stockholm Sweden

Department of Medical Microbiology University Medical Centre Utrecht Utrecht Netherlands

Department of Medicine Division of Infectious Diseases Karolinska Institutet Stockholm Sweden

European Vaccine Initiative Heidelberg Germany

German Centre for Infection Research Partner Site Bonn Cologne Cologne Germany

Hospital La Paz Institute for Health Research Madrid Spain

Infectious Diseases Department of Diagnostic and Public Health University of Verona Verona Italy

Influenza Centre Department of Clinical Science University of Bergen Bergen Norway

Institut National de la Santé et de la Recherche Médicale France Recherche Nord and Sud Sida HIV Hépatites Maladies Infectieuses Émergentes Paris France

Institute of Clinical Medicine Medical Faculty Vilnius University Vilnius Lithuania

Julius Center for Health Sciences and Primary Care University Medical Centre Utrecht Utrecht University Utrecht Netherlands

Masaryk University Brno Czech Republic

Medizinische Universität Wien Vienna Austria

Ministry of Health of Israel Jerusalem Israel

National Koranyi Institute for Pulmonology Budapest Hungary

School of Medicine European University Cyprus Nicosia Cyprus

Servicio Madrileño de Salud Madrid Spain

University Hospital Brno Brno Czech Republic

University Medical Centre Utrecht Utrecht University Utrecht Netherlands

VAXINFECTIO Centre of Evaluation of Vaccination Faculty of Medicine and Health Science Universiteit Antwerpen Antwerp Belgium

Vilnius University Hospital Santaros klinikos Medical Faculty Vilnius University Vilnius Lithuania

See more in PubMed

VACCELERATE - European Corona Vaccine Trial Accelerator Platform. European Commission. CORDIS EU Research Results. [2023-03-24]. https://cordis.europa.eu/project/id/101037867 .

Salmanton-García Jon, Stewart FA, Heringer S, Koniordou M, Álvarez-Barco Elena, Argyropoulos CD, Themistocleous SC, Valle-Simón Paula, Spivak O, Součková Lenka, Merakou C, Amélia Mendonça Maria, 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 Catarina, Leckler J, Launay O, Isitt C, Hellemans M, Frías-Iniesta Jesús, 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 Pontus, Tacconelli E, Tóth Krisztina, Zaoutis TE, Zeitlinger M, Cornely OA, Pana Z, VACCELERATE consortium VACCELERATE Volunteer Registry: a European study participant database to facilitate clinical trial enrolment. Vaccine. 2022 Jul 29;40(31):4090–4097. doi: 10.1016/j.vaccine.2022.05.022. S0264-410X(22)00605-3 PubMed DOI PMC

Health Emergency Preparedness and Response (HERA) European Commission. [2023-03-24]. https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera_en .

McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med. 1994 Sep;69(9):695–698. doi: 10.1097/00001888-199409000-00002. PubMed DOI

Jaklevic MC. Researchers strive to recruit hard-hit minorities into COVID-19 vaccine trials. JAMA. 2020 Sep 01;324(9):826–828. doi: 10.1001/jama.2020.11244.2769611 PubMed DOI

Langford AT. Health communication and decision making about vaccine clinical trials during a pandemic. J Health Commun. 2020 Oct 02;25(10):780–789. doi: 10.1080/10810730.2020.1864520. PubMed DOI PMC

Finset A, Bosworth H, Butow P, Gulbrandsen P, Hulsman RL, Pieterse AH, Street R, Tschoetschel R, van Weert J. Effective health communication - a key factor in fighting the COVID-19 pandemic. Patient Educ Couns. 2020 May;103(5):873–876. doi: 10.1016/j.pec.2020.03.027. S0738-3991(20)30185-3 PubMed DOI PMC

Earnshaw V, Eaton L, Kalichman S, Brousseau N, Hill E, Fox A. COVID-19 conspiracy beliefs, health behaviors, and policy support. Transl Behav Med. 2020 Oct 08;10(4):850–856. doi: 10.1093/tbm/ibaa090. 5903782 PubMed DOI PMC

MacDonald N, SAGE Working Group on Vaccine Hesitancy Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161–4164. doi: 10.1016/j.vaccine.2015.04.036. S0264-410X(15)00500-9 PubMed DOI

Gottlieb M, Dyer S. Information and disinformation: social media in the COVID-19 crisis. Acad Emerg Med. 2020 Jul 24;27(7):640–641. doi: 10.1111/acem.14036. PubMed DOI PMC

Naeem SB, Bhatti R, Khan A. An exploration of how fake news is taking over social media and putting public health at risk. Health Info Libr J. 2021 Jun 12;38(2):143–149. doi: 10.1111/hir.12320. PubMed DOI PMC

Tannenbaum MB, Hepler J, Zimmerman RS, Saul L, Jacobs S, Wilson K, Albarracín Dolores. Appealing to fear: A meta-analysis of fear appeal effectiveness and theories. Psychol Bull. 2015 Nov;141(6):1178–1204. doi: 10.1037/a0039729. 2015-48611-002 PubMed DOI PMC

Gisondi MA, Barber R, Faust JS, Raja A, Strehlow MC, Westafer LM, Gottlieb M. A deadly infodemic: social media and the power of COVID-19 misinformation. J Med Internet Res. 2022 Feb 01;24(2):e35552. doi: 10.2196/35552. v24i2e35552 PubMed DOI PMC

Suarez-Lledo V, Alvarez-Galvez J. Prevalence of health misinformation on social media: systematic review. J Med Internet Res. 2021 Jan 20;23(1):e17187. doi: 10.2196/17187. v23i1e17187 PubMed DOI PMC

Chou WS, Oh A, Klein WMP. Addressing health-related misinformation on social media. JAMA. 2018 Dec 18;320(23):2417–2418. doi: 10.1001/jama.2018.16865.2715795 PubMed DOI

Infodemic. World Health Organization. [2023-03-24]. https://www.who.int/health-topics/infodemic .

Lee SK, Sun J, Jang S, Connelly S. Misinformation of COVID-19 vaccines and vaccine hesitancy. Sci Rep. 2022 Aug 11;12(1):13681. doi: 10.1038/s41598-022-17430-6. doi: 10.1038/s41598-022-17430-6.10.1038/s41598-022-17430-6 PubMed DOI PMC

Surajit B. Vaccine hesitancy and misinformation about clinical trials. Indian J Surg. 2021 Jun 24;83(3):615–616. doi: 10.1007/s12262-021-03011-w. 3011 PubMed DOI PMC

Ginossar T, Diaz Fuentes C, Oetzel J. Understanding willingness to participate in cancer clinical trials among patients and caregivers attending a minority-serving academic cancer center. J Cancer Educ. 2022 Feb 14;37(1):179–187. doi: 10.1007/s13187-020-01802-5.10.1007/s13187-020-01802-5 PubMed DOI PMC

Habr D, Ferdinand R. Addressing racial/ethnic disparities in cancer clinical trials: everyone has a role to play. Cancer. 2021 Sep 15;127(18):3282–3289. doi: 10.1002/cncr.33600. PubMed DOI

Jennings W, Stoker G, Bunting H, Valgarðsson Viktor Orri, Gaskell J, Devine D, McKay L, Mills MC. Lack of trust, conspiracy beliefs, and social media use predict COVID-19 vaccine hesitancy. Vaccines (Basel) 2021 Jun 03;9(6):593. doi: 10.3390/vaccines9060593. vaccines9060593 PubMed DOI PMC

Luís C, Di Marzo VR, Kaur M, Argyropoulos C, Devane D, Stewart FA, Antoniou G, Hendrickx G, Hervius Askling H, Hellemans M, Cohen M, Spivak O, Van Damme P, Cox RJ, Vene S, Sibia S, Pana ZD, Olesen O, VACCELERATE Consortium OBO. Vaccination rates in Europe are not associated with online media intensity. JCOM. 2022;21(05):A05. doi: 10.22323/2.21050205. doi: 10.22323/2.21050205. DOI

DiClemente R, Crosby R, Kegler M. Emerging theories in health promotion practice and research strategies for improving public health. San Francisco, CA: Jossey-Bass; 2002. Understanding and applying theory in health promotion practice and research.

Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1–26. doi: 10.1146/annurev.psych.52.1.1.52/1/1 PubMed DOI

Beatty AL, Peyser ND, Butcher XE, Carton TW, Olgin JE, Pletcher MJ, Marcus GM. The COVID-19 Citizen Science Study: protocol for a longitudinal digital health cohort study. JMIR Res Protoc. 2021 Aug 30;10(8):e28169. doi: 10.2196/28169. v10i8e28169 PubMed DOI PMC

Marcus GM, Olgin JE, Peyser ND, Vittinghoff E, Yang V, Joyce S, Avram R, Tison GH, Wen D, Butcher X, Eitel H, Pletcher MJ. Predictors of incident viral symptoms ascertained in the era of COVID-19. PLoS One. 2021 Jun 17;16(6):e0253120. doi: 10.1371/journal.pone.0253120. PONE-D-20-27936 PubMed DOI PMC

Paul K, Palfinger T. Walking the (argumentative) talk using citizen science: involving young people in a critical policy analysis of vaccination policy in Austria. Evid Policy. 2020;16(2):229–247. doi: 10.1332/174426419X15752578285791. DOI

Hills M, Mullett J, Carroll S. Community-based participatory action research: transforming multidisciplinary practice in primary health care. Rev Panam Salud Publica. 2007;21(2-3):125–135. doi: 10.1590/s1020-49892007000200007.S1020-49892007000200007 PubMed DOI

VACCELERATE Official Website. [2023-03-24]. https://vaccelerate.eu/

Volunteer-Registry. Vaccelerate. [2023-03-24]. https://vaccelerate.eu/volunteer-registry-2/

Ohannessian R, Yaghobian S, Verger P, Vanhems P. A systematic review of serious video games used for vaccination. Vaccine. 2016 Aug 31;34(38):4478–4483. doi: 10.1016/j.vaccine.2016.07.048. doi: 10.1016/j.vaccine.2016.07.048.S0264-410X(16)30646-6 PubMed DOI

Ricciardi F, De Paolis LT. A comprehensive review of serious games in health professions. Int J Comput Games Technol. 2014;2014:1–11. doi: 10.1155/2014/787968. DOI

Lin A, Vittinghoff E, Olgin J, Peyser N, Aung S, Joyce S, Yang V, Hwang J, Avram R, Nah G, Tison GH, Beatty A, Runge R, Wen D, Butcher X, Horner C, Eitel H, Pletcher M, Marcus GM. Predictors of incident SARS-CoV-2 infections in an international prospective cohort study. BMJ Open. 2021 Sep 21;11(9):e052025. doi: 10.1136/bmjopen-2021-052025. bmjopen-2021-052025 PubMed DOI PMC

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