作者
Selidji T Agnandji, Angela Huttner, Madeleine E Zinser, Patricia Njuguna, Christine Dahlke, José F Fernandes, Sabine Yerly, Julie-Anne Dayer, Verena Kraehling, Rahel Kasonta, Akim A Adegnika, Marcus Altfeld, Floriane Auderset, Emmanuel B Bache, Nadine Biedenkopf, Saskia Borregaard, Jessica S Brosnahan, Rebekah Burrow, Christophe Combescure, Jules Desmeules, Markus Eickmann, Sarah K Fehling, Axel Finckh, Ana Rita Goncalves, Martin P Grobusch, Jay Hooper, Alen Jambrecina, Anita L Kabwende, Gürkan Kaya, Domtila Kimani, Bertrand Lell, Barbara Lemaître, Ansgar W Lohse, Marguerite Massinga-Loembe, Alain Matthey, Benjamin Mordmüller, Anne Nolting, Caroline Ogwang, Michael Ramharter, Jonas Schmidt-Chanasit, Stefan Schmiedel, Peter Silvera, Felix R Stahl, Henry M Staines, Thomas Strecker, Hans C Stubbe, Benjamin Tsofa, Sherif Zaki, Patricia Fast, Vasee Moorthy, Laurent Kaiser, Sanjeev Krishna, Stephan Becker, Marie-Paule Kieny, Philip Bejon, Peter G Kremsner, Marylyn M Addo, Claire-Anne Siegrist
发表日期
2016/4/28
期刊
New England Journal of Medicine
卷号
374
期号
17
页码范围
1647-1660
出版商
Massachusetts Medical Society
简介
Background
The replication-competent recombinant vesicular stomatitis virus (rVSV)–based vaccine expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity testing before its use in West Africa.
Methods
We performed three open-label, dose-escalation phase 1 trials and one randomized, double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and Africa. All participants were injected with doses of vaccine ranging from 300,000 to 50 million plaque-forming units (PFU) or placebo.
Results
No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset reactogenicity was frequent but transient (median, 1 day). Fever was observed in up to 30% of vaccinees. Vaccine viremia was detected within 3 days in 123 of the 130 participants (95 …
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ST Agnandji, A Huttner, ME Zinser, P Njuguna… - New England Journal of Medicine, 2016