Sardana Ratna, Kingebeni Placide Mbala, Snc Wiwit Agung, Beavogui Abdoul H, Biampata Jean-Luc, Dabitao Djeneba, de Blas Paola Del Carmen Guerra, Gayedyu-Dennis Dehkontee, Haidara Mory C, Jargalsaikhan Ganbolor, Nyuangar Garmai, Purnama Asep, Palacios Guillermo Ruiz, Samake Seydou, Tounkara Moctar, Weyers Shera, Zulkhuu Delgersaikhan, Hunsberger Sally, Ridzon Renee
Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo.
PLOS Glob Public Health. 2023 Jun 20;3(6):e0001918. doi: 10.1371/journal.pgph.0001918. eCollection 2023.
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.
关于新冠疫苗免疫原性、反应原性和有效性的国际研究是一项观察性研究，旨在评估刚果民主共和国、几内亚、印度尼西亚、利比里亚、马里、墨西哥和蒙古使用的新冠疫苗的免疫原性。该研究已招募了5401名成年人，并对参与者进行了约两年的前瞻性跟踪。这项研究很重要，因为它招募了来自资源有限地区的参与者，而在疫情期间，这些地区在很大程度上被排除在新冠研究之外。在国际卫生紧急情况期间开展一项研究面临重大挑战，尤其是在资源有限的地区。在此，我们重点关注在研究规划和实施过程中在研究后勤、国家疫苗政策、疫情引发的和供应链限制以及文化信仰方面遇到的挑战和障碍。我们还强调了通过团队的积极思考、协作方法和创新解决方案成功缓解这些挑战的情况。这项研究展示了如何利用资源有限地区的现有项目在应对疫情期间为生物医学研究做出贡献。从这项研究中吸取的经验教训可应用于在全球卫生危机期间迅速开展的其他研究，并将有助于在未来迫切需要紧急应对和数据收集时提高大流行防范能力。
