Evidence map›Paper›PMID 40694516›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Enhancing Clinical Trial Sites in Low- and Middle-Income Countries to Facilitate Product Development in Response to the COVID-19 Pandemic.

Sophie S Y Kang, Birkneh Tilahun Tadesse, Hyon Jin Jeon, Mosoka P Fallah, Nebiyu Dereje, Olayinka Stephen Ilesanmi, Solomon Mequanente Abay, Betelhem I Tekle, Hayoung G Son, Laxman Shrestha and 15 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Sophie S Y KangInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0001-9585-3556
Birkneh Tilahun TadesseInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0003-4005-8605
Hyon Jin JeonInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0002-2344-4574
Mosoka P FallahAfrica Centres for Disease Control and Prevention, Science and Innovation Directorate, Addis Ababa, Ethiopia.
Nebiyu DerejeAfrica Centres for Disease Control and Prevention, Science and Innovation Directorate, Addis Ababa, Ethiopia.
Olayinka Stephen IlesanmiAfrica Centres for Disease Control and Prevention, Science and Innovation Directorate, Addis Ababa, Ethiopia.
Solomon Mequanente AbayInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0002-7844-3771
Betelhem I TekleInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0009-0005-2670-9848
Hayoung G SonInternational Vaccine Institute, Seoul, Republic of Korea.
Laxman ShresthaInstitute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.
Anita ShresthaInstitute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.
Hasia V RamisoTropical Disease Foundation, Makati City, Philippines.
Vincent CanouetInternational Vaccine Institute, Seoul, Republic of Korea.
Yeonseon KimInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0009-0000-1728-778X
Kwaku Poku AsanteKintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana.
Japhet AnimKintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana.
Seyram KaaliKintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana.
Maria Rosario CapedingTropical Disease Foundation, Makati City, Philippines.
Ilesh V JaniInstituto Nacional de Saùde, Maputo, Mozambique.ORCID 0000-0002-6880-6655
Igor CapitineInstituto Nacional de Saùde, Maputo, Mozambique.
Arlete MahumaneInstituto Nacional de Saùde, Maputo, Mozambique.
T Anh WartelInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0009-0006-2693-9560
Andrea Haekyung HaselbeckInternational Vaccine Institute, Seoul, Republic of Korea.
Tarun SalujaInternational Vaccine Institute, Seoul, Republic of Korea.
Florian MarksInternational Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0002-6043-7170

Funding

Coalition for Epidemic Preparedness InnovationsGates Foundation INV-021539Gates Foundation INV-021581
6 · The paper itself

Abstract

backgroundThe 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.

methodsWith 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.

resultsDespite 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.

conclusionsThis 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)."

Indexed as

Clinical Trials, Phase III as TopicCOVID-19COVID-19 VaccinesVaccine DevelopmentCapacity BuildingClinical Trials as TopicDeveloping CountriesGhanaHumansNepalPandemicsPhilippinesSARS-CoV-2COVID-19 Vaccinescapacity enhancementclinical trialCOVID-19pandemic preparednessvaccine

Identifiers

PMID40694516
PMCPMC12282514

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.