Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding,

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Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study Olga De Santis, MRes, Régine Audran, PhD, Emilie Pothin, PhD, Loane Warpelin-Decrausaz, PhD, Laure Vallotton, MD, Grégoire Wuerzner, MD, Camille Cochet, MD, Daniel Estoppey, MD, Viviane Steiner-Monard, MD, Sophie Lonchampt, MSc, Anne-Christine Thierry, BS, Carole Mayor, BS, Robert T Bailer, PhD, Olivier Tshiani Mbaya, MD, Yan Zhou, PhD, Aurélie Ploquin, PhD, Nancy J Sullivan, PhD, Barney S Graham, MD, François Roman, MD, Iris De Ryck, MD, W Ripley Ballou, MD, Marie Paule Kieny, PhD, Vasee Moorthy, MD, François Spertini, MD, Prof Blaise Genton, MD The Lancet Infectious Diseases Volume 16, Issue 3, Pages 311-320 (March 2016) DOI: 10.1016/S1473-3099(15)00486-7 Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile The Lancet Infectious Diseases 2016 16, 311-320DOI: (10.1016/S1473-3099(15)00486-7) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 2 Proportion of individuals affected and severity of adverse events in non-deployed participants (A) Adverse events reported up to day 7 (plus 1 day, up to 8 days). (B) Adverse events reported up to day 28 (plus 7 days, up to 35 days). Only the maximum grade per adverse event was reported for each individual. The Lancet Infectious Diseases 2016 16, 311-320DOI: (10.1016/S1473-3099(15)00486-7) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 3 Antibody responses to the Ebola Zaire glycoprotein (A) Kinetics of responses as assessed by commercial ELISA. Boxes show median values and IQRs; whiskers are 5th and 95th percentiles, and geometric mean concentrations (μg/mL) are compared between groups. P values from the Mann–Whitney test. (B) Individual Vaccine Research Centre (VRC)-assessed EC90 titres at day 28. Squares show geometric mean concentrations and vertical lines show 95% CIs. (C) Spearman's correlation between the two ELISA assays (Lausanne and VRC). EC90=90% effective concentration (the dilution of serum at which there is a 90% decrease in antigen binding). The Lancet Infectious Diseases 2016 16, 311-320DOI: (10.1016/S1473-3099(15)00486-7) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 4 Memory T-cell responses to the Ebola virus Zaire glycoprotein Kinetics of individual CD4 (A) and CD8 (B) responses expressed as frequencies of subsets expressing at least one cytokine, IFN-γ, IL-2, or TNFα. Boxes show median values and IQRs; whiskers are 5% percentiles. We used the Kruskal–Wallis test to assess statistical significance of vaccine versus placebo. Proportions of glycoprotein-specific memory CD4 (C) and CD8 (D) cells that produce any combination of the three cytokines, at day 14 and day 28, in the vaccine groups. TNF=tumour necrosis factor. IL=interleukin. IFN=interferon. The Lancet Infectious Diseases 2016 16, 311-320DOI: (10.1016/S1473-3099(15)00486-7) Copyright © 2016 Elsevier Ltd Terms and Conditions