title: Early phase clinical trials with human immunodeficiency virus-1 and malaria vectored vaccines in The Gambia: frontline challenges in study design and implementation.
abstract: 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.
authors.affiliation: 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.
authors.forename: Muhammed O
authors.initials: MO
authors.lastname: Afolabi
authors.forename: Jane U
authors.initials: JU
authors.lastname: Adetifa
authors.forename: Egeruan B
authors.initials: EB
authors.lastname: Imoukhuede
authors.forename: Nicola K
authors.initials: NK
authors.lastname: Viebig
authors.forename: Beate
authors.initials: B
authors.lastname: Kampmann
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology / Q000517:prevention & control*; D017321:Clinical Trials, Phase I as Topic; D003906:Developing Countries; D005714:Gambia / Q000453:epidemiology; D015497:HIV-1; D006801:Humans; D008288:Malaria / Q000453:epidemiology / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000627:therapeutic use*
chemical_list: D016915:AIDS Vaccines; D017780:Malaria Vaccines