Early Phase Clinical Trials with Human Immunodeficiency Virus-1 and Malaria Vectored Vaccines in The Gambia: Frontline Challenges in Study Design and Implementation

Muhammed O. Afolabi Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Jane U. Adetifa Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Egeruan B. Imoukhuede Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Nicola K. Viebig Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Beate Kampmann Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Kalifa Bojang Vaccinology Theme, Medical Research Council Unit, The Gambia; The Jenner Institute, University of Oxford, United Kingdom; European Vaccine Initiative, Germany; Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia

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Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and malaria are among the most important infectious diseases in developing countries. Existing control strategies are unlikely to curtail these diseases in the absence of efficacious vaccines. Testing of HIV and malaria vaccines candidates start with early phase trials that are increasingly being conducted in developing countries where the burden of the diseases is high. Unique challenges, which affect planning and implementation of vaccine trials according to internationally accepted standards have thus been identified. In this review, we highlight specific challenges encountered during two early phase trials of novel HIV-1 and malaria vectored vaccine candidates conducted in The Gambia and how some of these issues were pragmatically addressed. We hope our experience will be useful for key study personnel involved in day-to-day running of similar clinical trials. It may also guide future design and implementation of vaccine trials in resource-constrained settings.

Author Notes

* Address correspondence to Muhammed O. Afolabi, Medical Research Council Unit, Atlantic Road, Fajara, P.O. Box 273, Banjul, The Gambia. E-mail: mafolabi@mrc.gm

Financial support: We thank European and Developing Countries Clinical Trials Partnership for funding the two trials: (EDCTP grant nos. IP.2008.31100.001 and CT.2006.33111.002).

Authors' addresses: Muhammed O. Afolabi, Jane U. Adetifa, and Beate Kampmann, Vaccinology Theme, Medical Research Council Unit, Fajara, The Gambia, E-mails: mafolabi@mrc.gm, jadetifa@mrc.gm, and bkampmann@mrc.gm. Egeruan B. Imoukhuede, The Jenner Institute, University of Oxford, Oxford, UK, E-mail: egeruan.imoukhuede@ndm.ox.ac.uk. Nicola K. Viebig, European Vaccine Initiative, Heidelberg, Germany, E-mail: nicola.viebig@euvaccine.eu. Kalifa Bojang, Disease Control and Elimination Theme, Medical Research Council Unit, Fajara, The Gambia, E-mail: kbojang@mrc.gm.

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