Kang Sophie S Y, Tadesse Birkneh Tilahun, Jeon Hyon Jin, Fallah Mosoka P, Dereje Nebiyu, Ilesanmi Olayinka Stephen, Abay Solomon Mequanente, Tekle Betelhem I, Son Hayoung G, Shrestha Laxman, Shrestha Anita, Ramiso Hasia V, Canouet Vincent, Kim Yeonseon, Asante Kwaku Poku, Anim Japhet, Kaali Seyram, Capeding Maria Rosario, Jani Ilesh V, Capitine Igor, Mahumane Arlete, Wartel T Anh, Haselbeck Andrea Haekyung, Saluja Tarun, Marks Florian
International Vaccine Institute, Seoul, Republic of Korea.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Clin Infect Dis. 2025 Jul 22;80(Supplement_1):S1-S8. doi: 10.1093/cid/ciaf094.
The swift development of coronavirus disease 2019 (COVID-19) vaccines marked a monumental effort in global coordination and collaboration; however, there remained major disparities in vaccine access and research capacity across countries. Unequal participation in vaccine development studies from low- and middle- income countries (LMICs) clearly signaled an urgent need to strengthen health research infrastructure in those regions.
With funding from the Gates Foundation (GF), this site readiness initiative carried out rapid capacity enhancement activities to enable large-scale, Phase 3 pivotal clinical trial conduct in LMICs. The International Vaccine Institute (IVI) worked with site partners in four countries (Mozambique, Ghana, Nepal, and the Philippines) after conducting feasibility assessments for site selection. Site-specific gaps were identified, and capacity building activities focused on staff training, site infrastructure, and resource mobilization were carried out over roughly 7 months from October 2020 to May 2021.
Despite pandemic-related challenges such as supply chain shortages, by the end of the capacity building efforts all sites were either contracted to or in discussions with trial sponsors to conduct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine studies. This article provides an overview of the site selection process, critical components of site establishment, and final site readiness evaluations carried out amidst a global health emergency.
This experience illustrates the value of research capacity enhancement as essential to both pandemic preparedness and global health equity. The lessons learned are being carried into an ongoing initiative across West Africa, currently underway as the "Advancing Research Capabilities in West Africa (ARC-WA)."
2019年冠状病毒病（COVID-19）疫苗的迅速研发标志着全球协调与合作方面的一项巨大努力；然而，各国在疫苗获取和研究能力方面仍存在重大差距。低收入和中等收入国家（LMICs）在疫苗研发研究中的参与不平等，这清楚地表明迫切需要加强这些地区的卫生研究基础设施。
在盖茨基金会（GF）的资助下，该场地准备计划开展了快速能力提升活动，以使低收入和中等收入国家能够开展大规模的3期关键临床试验。国际疫苗研究所（IVI）在对场地选择进行可行性评估后，与四个国家（莫桑比克、加纳、尼泊尔和菲律宾）的场地合作伙伴合作。确定了特定场地的差距，并在2020年10月至2021年5月的大约7个月时间里开展了侧重于人员培训、场地基础设施和资源调动的能力建设活动。
尽管面临供应链短缺等与疫情相关的挑战，但在能力建设工作结束时，所有场地要么已与试验赞助商签订合同，要么正在与试验赞助商讨论开展严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗研究。本文概述了场地选择过程、场地设立的关键组成部分以及在全球卫生紧急情况期间进行的最终场地准备评估。
这一经验表明，提高研究能力对于大流行防范和全球卫生公平至关重要。所吸取的经验教训正在被纳入正在西非开展的一项倡议，即目前正在进行的“西非推进研究能力（ARC-WA）”。
