RESEARCH ARTICLE Safety and immunogenicity of rVSVΔG-ZEBOV- GP Ebola vaccine in adults and children in Lambare´ne ´, Gabon: A phase I randomised trial Selidji T. Agnandji 1,2,3☯ , Jose ´ F. Fernandes 1,2☯ , Emmanuel B. Bache 1 , Re ´ gis M. Obiang Mba 1 , Jessica S. Brosnahan 1,2,3 , Lumeka Kabwende 1 , Paul Pitzinger 1,2,4 , Pieter Staarink 1,5 , Marguerite Massinga-Loembe 1 , Verena Kra ¨ hling 3,6 , Nadine Biedenkopf 6 , Sarah Katharina Fehling 6 , Thomas Strecker 6 , David J. Clark 7 , Henry M. Staines 7 , Jay W. Hooper 8 , Peter Silvera 8 , Vasee Moorthy 9 , Marie-Paule Kieny 9 , Akim A. Adegnika 1,2,3,10 , Martin P. Grobusch 1,2,5 , Stephan Becker 3,6 , Michael Ramharter 1,2,4 , Benjamin Mordmu ¨ ller 1,2,3 , Bertrand Lell 1,2,3 , VEBCON Consortium ¶ , Sanjeev Krishna 1,2,7,11 *, Peter G. Kremsner 1,2,3 * 1 Centre de Recherches Me ´ dicales de Lambare ´ne ´ , Lambare ´ne ´ , Gabon, 2 Institut fu ¨r Tropenmedizin, Universita ¨ tsklinikum Tu ¨ bingen, Tu ¨ bingen, Germany, 3 German Centre for Infection Research (DZIF) partner sites Universita ¨ tsklinikum Tu ¨bingen and Gießen-Marburg-Langen, Germany, 4 Bernhard Nocht Hospital for Tropical Diseases, Bernhard Nocht Institute for Tropical Medicine and University Medical Center Hamburg- Eppendorf, Hamburg, Germany, 5 Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands, 6 Institute for Virology, Philipps-Universita ¨ t Marburg, Marburg, Germany, 7 Centre for Diagnostics and Antimicrobial Resistance, Institute for Infection & Immunity, St. George’s, University of London, London, United Kingdom, 8 US Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, United States of America, 9 World Health Organization, Geneva, Switzerland, 10 Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands, 11 St. George’s University Hospitals NHS Foundation Trust, London, United Kingdom ☯ These authors contributed equally to this work. ¶ Membership of the VEBCON Consortium is provided in the Acknowledgments. * s.krishna@sgul.ac.uk (SK); peter.kremsner@uni-tuebingen.de (PGK) Abstract Background The rVSVΔG-ZEBOV-GP vaccine prevented Ebola virus disease when used at 2 × 10 7 pla- que-forming units (PFU) in a trial in Guinea. This study provides further safety and immuno- genicity data. Methods and findings A randomised, open-label phase I trial in Lambare ´ne ´ , Gabon, studied 5 single intramuscular vaccine doses of 3 × 10 3 ,3 × 10 4 ,3 × 10 5 ,3 × 10 6 , or 2 × 10 7 PFU in 115 adults and a dose of 2 × 10 7 PFU in 20 adolescents and 20 children. The primary objective was safety and tol- erability 28 days post-injection. Immunogenicity, viraemia, and shedding post-vaccination were evaluated as secondary objectives. In adults, mild-to-moderate adverse events were frequent, but there were no serious or severe adverse events related to vaccination. Before vaccination, Zaire Ebola virus (ZEBOV)–glycoprotein (GP)–specific and ZEBOV antibodies PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002402 October 6, 2017 1 / 26 a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 OPEN ACCESS Citation: Agnandji ST, Fernandes JF, Bache EB, Obiang Mba RM, Brosnahan JS, Kabwende L, et al. (2017) Safety and immunogenicity of rVSVΔG- ZEBOV-GP Ebola vaccine in adults and children in Lambare ´ne ´, Gabon: A phase I randomised trial. PLoS Med 14(10): e1002402. https://doi.org/ 10.1371/journal.pmed.1002402 Academic Editor: Lorenz von Seidlein, Mahidol- Oxford Tropical Medicine Research Unit, THAILAND Received: March 21, 2017 Accepted: September 7, 2017 Published: October 6, 2017 Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication. Data Availability Statement: Metadata used to generate the results of this manuscript have been submitted to the Dryad Digital Repository: https:// datadryad.org/resource/doi:10.5061/dryad.n515p. http://dx.doi.org/10.5061/dryad.n515p. Funding: The Universita ¨tsklinikum Tu ¨bingen in Germany was the clinical sponsor of the trial. Funds for conduct of the trial and for sponsorship costs were provided by the Wellcome Trust (UK),