NDLI: Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Auderset, Floriane Combescure, Christophe Staines, Henry M. Yerly, Sabine Grobusch, Martin P. Dahlke, Christine Jambrecina, Alen Strecker, Thomas Moorthy, Vasee Hooper, Jay Matthey, Alain Brosnahan, Jessica S. Njuguna, Patricia Stahl, Felix R. Schmidt-chanasit, Jonas Fast, Patricia Desmeules, Jules Kaya, Gürkan Schmiedel, Stefan Finckh, Axel Agnandji, Selidji T. Silvera, Peter Lell, Bertrand Nolting, Anne Eickmann, Markus Adegnika, Akim A. Bache, Emmanuel B. Zaki, Sherif Borregaard, Saskia Kimani, Domtila Massinga-loembe, Marguerite Burrow, Rebekah Lemaître, Barbara Ogwang, Caroline Biedenkopf, Nadine Dayer, Julie-anne Kraehling, Verena Kasonta, Rahel Stubbe, Hans C. Fernandes, José F. Zinser, Madeleine E. Tsofa, Benjamin Goncalves, Ana Rita Lohse, Ansgar W. Huttner, Angela Fehling, Sarah K. Mordmüller, Benjamin Ramharter, Michael Altfeld, Marcus Kabwende, Anita L.
Description	Author Affiliation: Agnandji ST ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Huttner A ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Zinser ME ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Njuguna P ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Dahlke C ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Fernandes JF ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Yerly S ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Dayer JA ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Kraehling V ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Kasonta R ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Adegnika AA ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Altfeld M ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Auderset F ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Bache EB ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Biedenkopf N ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Borregaard S ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Brosnahan JS ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Burrow R ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Combescure C ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Desmeules J ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Eickmann M ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Fehling SK ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Finckh A ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Goncalves AR ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Grobusch MP ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Hooper J ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Jambrecina A ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Kabwende AL ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Kaya G ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Kimani D ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Lell B ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Lemaître B ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Lohse AW ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Massinga-Loembe M ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Matthey A ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Mordmüller B ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Nolting A ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Ogwang C ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Ramharter M ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Schmidt-Chanasit J ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Schmiedel S ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Silvera P ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Stahl FR ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Staines HM ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Strecker T ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Stubbe HC ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Tsofa B ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Zaki S ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Fast P ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.)); Moorthy V ( From the Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon (S.T.A., J.F.F., A.A.A., E.B.B., J.S.B., M.P.G., A.L.K., B. Lell, M.M.-L., B.M., M.R., S.K., P.G.K.))
Abstract	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%) receiving 3 million PFU or more; rVSV was not detected in saliva or urine. In the second week after injection, arthritis affecting one to four joints developed in 11 of 51 participants (22%) in Geneva, with pain lasting a median of 8 days (interquartile range, 4 to 87); 2 self-limited cases occurred in 60 participants (3%) in Hamburg, Germany, and Kilifi, Kenya. The virus was identified in one synovial-fluid aspirate and in skin vesicles of 2 other vaccinees, showing peripheral viral replication in the second week after immunization. ZEBOV-glycoprotein-specific antibody responses were detected in all the participants, with similar glycoprotein-binding antibody titers but significantly higher neutralizing antibody titers at higher doses. Glycoprotein-binding antibody titers were sustained through 180 days in all participants. CONCLUSIONS: In these studies, rVSV-ZEBOV was reactogenic but immunogenic after a single dose and warrants further evaluation for safety and efficacy. (Funded by the Wellcome Trust and others; ClinicalTrials.gov numbers, NCT02283099, NCT02287480, and NCT02296983; Pan African Clinical Trials Registry number, PACTR201411000919191.).
ISSN	00284793
Issue Number	17
Volume Number	374
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2016-04-28
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Ebola Vaccines Immunology Ebolavirus Hemorrhagic Fever, Ebola Prevention & Control Membrane Glycoproteins Viral Envelope Proteins Adult Antibodies, Viral Blood Arthritis Etiology Dermatitis Double-Blind Method Administration & Dosage Adverse Effects Isolation & Purification Exanthema Female Humans Male Middle Aged Recombinant Proteins Viremia Virus Shedding Clinical Trial, Phase I Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S. Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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