Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial,

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Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double- blind, placebo-controlled trial  Milagritos D Tapia, MD, Prof Samba O Sow, MD, Kirsten E Lyke, MD, Fadima Cheick Haidara, MD, Fatoumata Diallo, MD, Moussa Doumbia, MD, Awa Traore, PharmD, Flanon Coulibaly, MD, Mamoudou Kodio, PharmD, Uma Onwuchekwa, BS, Prof Marcelo B Sztein, MD, Rezwanul Wahid, PhD, Prof James D Campbell, MD, Marie-Paule Kieny, PhD, Vasee Moorthy, DPhil, Egeruan B Imoukhuede, MBBS, Tommy Rampling, MRCP, Francois Roman, MD, Iris De Ryck, MD, Abbie R Bellamy, PhD, Len Dally, MS, Olivier Tshiani Mbaya, MD, Aurélie Ploquin, PhD, Yan Zhou, PhD, Daphne A Stanley, MS, Robert Bailer, PhD, Richard A Koup, MD, Mario Roederer, PhD, Julie Ledgerwood, DO, Prof Adrian V S Hill, DM, W Ripley Ballou, MD, Nancy Sullivan, PhD, Barney Graham, MD, Prof Myron M Levine, MD  The Lancet Infectious Diseases  Volume 16, Issue 1, Pages 31-42 (January 2016) DOI: 10.1016/S1473-3099(15)00362-X Copyright © 2016 Tapia et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 1 Trial profile (A) Malian trial. (B) US trial. ChAd3-EBO-Z=replication-defective chimpanzee adenovirus 3 vector vaccine expressing Zaire Ebola virus glycoprotein. MVA-BN-Filo=modified vaccinia Ankara expressing Zaire Ebola virus glycoprotein and other filovirus antigens. pu=particle units. The Lancet Infectious Diseases 2016 16, 31-42DOI: (10.1016/S1473-3099(15)00362-X) Copyright © 2016 Tapia et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 2 Anti-Zaire Ebola virus glycoprotein ELISA titres (background subtracted) for the Malian participants in the nested MVA-BN-Filo booster trial Titres of individual participants are plotted as open circles at the actual week after priming immunisation with ChAd3-EBO-Z vaccine. GMTs are plotted as filled circles with associated 95% CIs. For participants in the booster study, their boost visits ranged from 11·2 weeks to 15·8 weeks after priming; the GMT for the boost visit is plotted at the median of 13 weeks, and the GMTs for postboost visits are plotted at the subsequent target intervals (ie, 1 week, 2 weeks, and 4 weeks after boosting). (A) Participants primed with ChAd3-EBO-Z and then boosted with saline placebo are compared with those primed with ChAd3-EBO-Z and then boosted with MVA-BN-Filo. (B) The longevity of the antiglycoprotein response in participants vaccinated with the 1 × 1011 pu high dose of ChAd3-EBO-Z and boosted with saline placebo is shown and compared with the magnitude of response of the participants who received low doses (1 × 1010 pu, 2·5 × 1010 pu, or 5 × 1010 pu) of ChAd3-EBO-Z, followed by a saline booster. ChAd3-EBO-Z=replication-defective chimpanzee adenovirus 3 vector vaccine expressing Zaire Ebola virus glycoprotein. GMT=geometric mean titre. MVA-BN-Filo=modified vaccinia Ankara expressing Zaire Ebola virus glycoprotein and other filovirus antigens. pu=particle units. The Lancet Infectious Diseases 2016 16, 31-42DOI: (10.1016/S1473-3099(15)00362-X) Copyright © 2016 Tapia et al. Open Access article distributed under the terms of CC BY Terms and Conditions