Challenges of conducting an international observational study to assess immunogenicity of multiple COVID-19 vaccines.

Autor:	Sardana R; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America., Kingebeni PM; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo., Snc WA; Rumah Sakit Umum Daerah Dr. H. Moch. Ansari Saleh Hospital, Banjarmasin, Indonesia., Beavogui AH; Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Maferinyah, Guinea., Biampata JL; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo., Dabitao D; University Clinical Research Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali., de Blas PDCG; The Mexican Emerging Infectious Diseases Clinical Research Network, Mexico City, Mexico., Gayedyu-Dennis D; Partnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia, Liberia., Haidara MC; Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Maferinyah, Guinea., Jargalsaikhan G; The Liver Center, Onom Foundation, Ulan Bator, Mongolia., Nyuangar G; Partnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia, Liberia., Purnama A; TC Hillers Hospital, Maumere, Indonesia., Palacios GR; Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Samake S; University Clinical Research Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali., Tounkara M; University Clinical Research Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali., Weyers S; Clinical Monitoring Research Program Directorate, Frederick National Laboratory, Frederick, Maryland, United States of America., Zulkhuu D; The Liver Center, Onom Foundation, Ulan Bator, Mongolia., Hunsberger S; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America., Ridzon R; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Jazyk:	angličtina
Zdroj:	PLOS global public health [PLOS Glob Public Health] 2023 Jun 20; Vol. 3 (6), pp. e0001918. Date of Electronic Publication: 2023 Jun 20 (Print Publication: 2023).
DOI:	10.1371/journal.pgph.0001918
Abstrakt:	The International Study on COVID-19 Vaccines to Assess Immunogenicity, Reactogenicity, and Efficacy is an observational study to assess the immunogenicity of COVID-19 vaccines used in Democratic Republic of Congo, Guinea, Indonesia, Liberia, Mali, Mexico, and Mongolia. The study, which has enrolled 5,401 adults, is prospectively following participants for approximately two years. This study is important as it has enrolled participants from resource-limited settings that have largely been excluded from COVID-19 research studies during the pandemic. There are significant challenges to mounting a study during an international health emergency, especially in resource-limited settings. Here we focus on challenges and hurdles encountered during the planning and implementation of the study with regard to study logistics, national vaccine policies, pandemic-induced and supply chain constraints, and cultural beliefs. We also highlight the successful mitigation of these challenges through the team's proactive thinking, collaborative approach, and innovative solutions. This study serves as an example of how established programs in resource-limited settings can be leveraged to contribute to biomedical research during a pandemic response. Lessons learned from this study can be applied to other studies mounted to respond rapidly during a global health crisis and will contribute to capacity for stronger pandemic preparedness in the future when there is a crucial need for urgent response and data collection. Competing Interests: The authors have declared that no competing interests exist. (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)
Databáze:	MEDLINE
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