title: Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.
abstract: The index case of the Ebola virus disease epidemic in West Africa is believed to have originated in Guinea. By June 2014, Guinea, Liberia, and Sierra Leone were in the midst of a full-blown and complex global health emergency. The devastating effects of this Ebola epidemic in West Africa put the global health response in acute focus for urgent international interventions. Accordingly, in October 2014, a World Health Organization high-level meeting endorsed the concept of a phase 2/3 clinical trial in Liberia to study Ebola vaccines. As a follow-up to the global response, in November 2014, the Government of Liberia and the US Government signed an agreement to form a research partnership to investigate Ebola and to assess intervention strategies for treating, controlling, and preventing the disease in Liberia. This agreement led to the establishment of the Joint Liberia-US Partnership for Research on Ebola Virus in Liberia as the beginning of a long-term collaborative partnership in clinical research between the two countries. In this article, we discuss the methodology and related challenges associated with the implementation of the Ebola vaccines clinical trial, based on a double-blinded randomized controlled trial, in Liberia.
authors.affiliation: Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia Incident Management System (IMS), Emergency Operations Center (EoC), Ministry of Health (MoH), Monrovia, Liberia kennedys@lpgmc.org.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Kennedy
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
authors.forename: James D
authors.initials: JD
authors.lastname: Neaton
authors.affiliation: Division of Clinical Research, National Institute of Allergy & Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: H Clifford
authors.initials: HC
authors.lastname: Lane
authors.affiliation: Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia.
authors.forename: Mark W S
authors.initials: MW
authors.lastname: Kieh
authors.affiliation: Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia Incident Management System (IMS), Emergency Operations Center (EoC), Ministry of Health (MoH), Monrovia, Liberia.
authors.forename: Moses B F
authors.initials: MB
authors.lastname: Massaquoi
authors.affiliation: Division of Clinical Research, National Institute of Allergy & Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Touchette
authors.affiliation: Division of Clinical Research, National Institute of Allergy & Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: Martha C
authors.initials: MC
authors.lastname: Nason
authors.affiliation: Division of Clinical Research, National Institute of Allergy & Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: Dean A
authors.initials: DA
authors.lastname: Follmann
authors.affiliation: Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia Liberian Institute for Biomedical Research (LIBR), Margibi, Liberia.
authors.forename: Fatorma K
authors.initials: FK
authors.lastname: Boley
authors.affiliation: Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia.
authors.forename: Melvin P
authors.initials: MP
authors.lastname: Johnson
authors.affiliation: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Gregg
authors.initials: G
authors.lastname: Larson
authors.affiliation: Incident Management System (IMS), Emergency Operations Center (EoC), Ministry of Health (MoH), Monrovia, Liberia Ministry of Health (MoH), Monrovia, Liberia.
authors.forename: Francis N
authors.initials: FN
authors.lastname: Kateh
authors.affiliation: Incident Management System (IMS), Emergency Operations Center (EoC), Ministry of Health (MoH), Monrovia, Liberia Ministry of Health (MoH), Monrovia, Liberia.
authors.forename: Tolbert G
authors.initials: TG
authors.lastname: Nyenswah
mesh_terms: D002985:Clinical Protocols; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D004311:Double-Blind Method; D046129:Ebola Vaccines; D005500:Follow-Up Studies; D019142:Hemorrhagic Fever, Ebola / Q000517:prevention & control*; D006801:Humans; D007391:International Cooperation; D007988:Liberia; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size; D014481:United States; D014944:World Health Organization
chemical_list: D046129:Ebola Vaccines
keywords: Ebola virus disease; Liberia; clinical trials; emerging and re-emerging infections; epidemics; infectious diseases; partnership; social mobilization