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Background <p>Pandemics have increasingly become more frequent. Globally, between 1970 and 2016, a total of over 1770 disease outbreaks of 38 known and two unknown causes were reported. Vaccines are a key medical countermeasure for most of these outbreaks, however, most of these are developed and tested outside Sub-Saharan Africa. There is underrepresentation of Africa in vaccine clinical trials. This is attributed to poor visibility of existing sites, limited infrastructure and unpredictable regulatory timelines, and lack of capacity and infrastructure for basic science research.</p> Main text <p>We draw on lessons from an Ebola outbreak in Uganda to suggest key factors to establishing a vaccine trial site in a low resource setting. The factors are trained clinical trial staff, availability and adaptation of generic trial protocols, establishment of vaccine cold chain storage facilities, south-south collaborations, in-country stewardship, and close collaboration with ethical and regulatory bodies.</p> Conclusion <p>African institutions could capitalise on the epidemics and the accompanying responses to build capacity for vaccine trials and position themselves to take part in global vaccine trials.</p>

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Leveraging an epidemic to establish vaccine clinical trial capacity in a low resource setting: the Ugandan experience

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月24日

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  • Winters Muttamba,
  • Alhassane Toure,
  • Misaki Wayengera,
  • Henry Kyobe Bosa,
  • Wilber Sabiiti,
  • Pauline Byakika-Kibwika,
  • Bruce Kirenga

摘要

Background

Pandemics have increasingly become more frequent. Globally, between 1970 and 2016, a total of over 1770 disease outbreaks of 38 known and two unknown causes were reported. Vaccines are a key medical countermeasure for most of these outbreaks, however, most of these are developed and tested outside Sub-Saharan Africa. There is underrepresentation of Africa in vaccine clinical trials. This is attributed to poor visibility of existing sites, limited infrastructure and unpredictable regulatory timelines, and lack of capacity and infrastructure for basic science research.

Main text

We draw on lessons from an Ebola outbreak in Uganda to suggest key factors to establishing a vaccine trial site in a low resource setting. The factors are trained clinical trial staff, availability and adaptation of generic trial protocols, establishment of vaccine cold chain storage facilities, south-south collaborations, in-country stewardship, and close collaboration with ethical and regulatory bodies.

Conclusion

African institutions could capitalise on the epidemics and the accompanying responses to build capacity for vaccine trials and position themselves to take part in global vaccine trials.