title: A review of Phase I trials of Ebola virus vaccines: what can we learn from the race to develop novel vaccines?
abstract: Sporadic outbreaks of Ebola virus infection have been documented since the mid-Seventies and viral exposure can lead to lethal haemorrhagic fever with case fatalities as high as 90%. There is now a comprehensive body of data from both ongoing and completed clinical trials assessing various vaccine strategies, which were rapidly advanced through clinical trials in response to the 2013-2016 Ebola virus disease (EVD) public health emergency. Careful consideration of immunogenicity post vaccination is essential but has been somewhat stifled because of the wide array of immunological assays and outputs that have been used in the numerous clinical trials. We discuss here the different aspects of the immune assays currently used in the Phase I clinical trials for Ebola virus vaccines, and draw comparisons across the immune outputs where possible; various trials have examined both cellular and humoral immunity in European and African cohorts. Assessment of the safety data, the immunological outputs and the ease of field deployment for the various vaccine modalities will help both the scientific community and policy-makers prioritize and potentially license vaccine candidates. If this can be achieved, the next outbreak of Ebola virus, or other emerging pathogen, can be more readily contained and will not have such widespread and devastating consequences.This article is part of the themed issue 'The 2013-2016 West African Ebola epidemic: data, decision-making and disease control'.
authors.affiliation: The Jenner Institute, University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Headington, Oxford OX3 7DQ, UK teresa.lambe@ndm.ox.ac.uk.
authors.forename: Teresa
authors.identifier: http://orcid.org/0000-0001-7711-897X
authors.initials: T
authors.lastname: Lambe
authors.affiliation: The Jenner Institute, University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Headington, Oxford OX3 7DQ, UK.
authors.forename: Georgina
authors.initials: G
authors.lastname: Bowyer
authors.affiliation: The Jenner Institute, University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Headington, Oxford OX3 7DQ, UK.
authors.forename: Katie J
authors.initials: KJ
authors.lastname: Ewer
mesh_terms: D000349:Africa; D017321:Clinical Trials, Phase I as Topic; D046129:Ebola Vaccines / Q000032:analysis / Q000627:therapeutic use* / Q000633:toxicity; D029043:Ebolavirus / Q000276:immunology*; D005060:Europe; D019142:Hemorrhagic Fever, Ebola / Q000517:prevention & control*; D006801:Humans; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D014611:Vaccination
chemical_list: D046129:Ebola Vaccines
keywords: Ebola virus; T cell; antibody; clinical trial; emerging pathogens; vaccine