Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled,

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Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trial Birahim Pierre Ndiaye, MD, Friedrich Thienemann, MD, Martin Ota, FWACP, Bernard S Landry, MPH, Makhtar Camara, PhD, Siry Dièye, MD, Tandakha Ndiaye Dieye, PhD, Hanif Esmail, MRCP, Rene Goliath, BSc, Kris Huygen, PhD, Vanessa January, Ibrahima Ndiaye, MD, Tolu Oni, MD, Michael Raine, BSc, Marta Romano, PhD, Iman Satti, PhD, Sharon Sutton, BS, Aminata Thiam, MD, Katalin A Wilkinson, PhD, Prof Souleymane Mboup, PhD, Prof Robert J Wilkinson, FRCP, Prof Helen McShane, FRCP The Lancet Respiratory Medicine Volume 3, Issue 3, Pages 190-200 (March 2015) DOI: 10.1016/S2213-2600(15)00037-5 Copyright © 2015 Ndiaye et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 1 Trial profile The Lancet Respiratory Medicine 2015 3, 190-200DOI: (10.1016/S2213-2600(15)00037-5) Copyright © 2015 Ndiaye et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 2 Vaccine immunogenicity (both study sites combined) (A) Antigen 85A (Ag85A) interferon γ enzyme-linked immunospot analysis responses. Data are presented as spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs). p values were calculated with Wilcoxon matched-pair signed-rank tests. Box and whisker plots show median, IQR, and minimum and maximum values. (B) Whole blood intracellular cytokine staining assay of total cytokines. Data are presented as frequency of CD4 and CD8 T cells producing cytokines. Box and whisker plots show median, IQR, and minimum and maximum values. IFNγ=interferon γ. TNFα=tumour necrosis factor α. IL=interleukin. V1=vaccination 1. V2=vaccination 2. The Lancet Respiratory Medicine 2015 3, 190-200DOI: (10.1016/S2213-2600(15)00037-5) Copyright © 2015 Ndiaye et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 3 Polyfunctional CD4 T cells Plots show frequency of CD4 T cells producing combinations of the studied cytokines. Bars are median values and dots represent individual volunteers. IFNγ=interferon γ. TNFα=tumour necrosis factor α. IL=interleukin. V1=vaccination 1. V2=vaccination 2. The Lancet Respiratory Medicine 2015 3, 190-200DOI: (10.1016/S2213-2600(15)00037-5) Copyright © 2015 Ndiaye et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 4 Cumulative incidence of diagnosis of tuberculosis endpoint 1 by treatment group Endpoint 1 was defined as a positive finding from culture or GeneXpert MTB/RIF assay. The Lancet Respiratory Medicine 2015 3, 190-200DOI: (10.1016/S2213-2600(15)00037-5) Copyright © 2015 Ndiaye et al. Open Access article distributed under the terms of CC BY Terms and Conditions