Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)
The study was designed to establish safety, tolerability and immunogenicity of the rVSVΔG-ZEBOV-GP vaccine candidate investigated at three different dose levels in 30 healthy adults. This study is part of the WHO led VEBCON consortium.
rVSV-ZEBOV is an attenuated, genetically modified vesicular stomatitis virus (VSV) that carries an Ebola virus surface protein called glycoprotein. The development of the vaccine was supervised by the WHO through VEBCON. The German Center for Infection Research (DZIF) supported the preparation of the trials at the UKE in Hamburg and in Gabon and provided initial funding.
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Publications
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Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaître B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmüller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Agnandji et al
Dahlke C, Kasonta R, Lunemann S, Krähling V, Zinser ME, Biedenkopf N, Fehling SK, Ly ML, Rechtien A, Stubbe HC, Olearo F, Borregaard S, Jambrecina A, Stahl F, Strecker T, Eickmann M, Lütgehetmann M, Spohn M, Schmiedel S, Lohse AW, Becker S, Addo MM; VEBCON Consortium. Dose-dependent T-cell Dynamics and Cytokine Cascade Following rVSV-ZEBOV Immunization. EBioMedicine. 2017 May;19:107-118. doi: 10.1016/j.ebiom.2017.03.045. Epub 2017 Apr 5. Dahlke et al
Rechtien A, Richert L, Lorenzo H, Martrus G, Hejblum B, Dahlke C, Kasonta R, Zinser M, Stubbe H, Matschl U, Lohse A, Krähling V, Eickmann M, Becker S; VEBCON Consortium, Thiébaut R, Altfeld M, Addo MM. Systems Vaccinology Identifies an Early Innate Immune Signature as a Correlate of Antibody Responses to the Ebola Vaccine rVSV-ZEBOV. Cell Rep. 2017 Aug 29;20(9):2251-2261. doi: 10.1016/j.celrep.2017.08.023. Rechtien et al
Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaître B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Huttner et al
Ehrhardt SA, Zehner M, Krähling V, Cohen-Dvashi H, Kreer C, Elad N, Gruell H, Ercanoglu MS, Schommers P, Gieselmann L, Eggeling R, Dahlke C, Wolf T, Pfeifer N, Addo MM, Diskin R, Becker S, Klein F. Polyclonal and convergent antibody response to Ebola virus vaccine rVSV-ZEBOV. Nat Med. 2019 Oct;25(10):1589-1600. doi: 10.1038/s41591-019-0602-4. Ehrhardt et al
Pejoski D, de Rham C, Martinez-Murillo P, Santoro F, Auderset F, Medaglini D, Pozzi G, Vono M, Lambert PH, Huttner A, Haks MC, Ottenhoff THM, Villard J, Siegrist CA; VEBCON Consortium; VSV-EBOVAC Consortium; VSV-EBOPLUS Consortium. Rapid dose-dependent Natural Killer (NK) cell modulation and cytokine responses following human rVSV-ZEBOV Ebolavirus vaccination. NPJ Vaccines. 2020 Apr 14;5(1):32. doi: 10.1038/s41541-020-0179-4. Pejoski et al
Koch T, Rottstegge M, Ruibal P, Gomez-Medina S, Nelson EV, Escudero-Pérez B, Pillny M, Ly ML, Koundouno FR, Bore JA, Magassouba N, Dahlke C, Günther S, Carroll MW, Addo MM, Muñoz-Fontela C. Ebola Virus Disease Survivors Show More Efficient Antibody Immunity than Vaccinees Despite Similar Levels of Circulating Immunoglobulins. Viruses. 2020 Aug 20;12(9):915. doi: 10.3390/v12090915. Koch et al
Heidepriem J, Krähling V, Dahlke C, Wolf T, Klein F, Addo MM, Becker S, Loeffler FF. Epitopes of Naturally Acquired and Vaccine-Induced Anti-Ebola Virus Glycoprotein Antibodies in Single Amino Acid Resolution. Biotechnol J. 2020 Sep;15(9):e2000069. doi: 10.1002/biot.202000069. Heidepriem et al
Friedrich SK, Schmitz R, Bergerhausen M, Lang J, Cham LB, Duhan V, Häussinger D, Hardt C, Addo M, Prinz M, Asano K, Lang PA, Lang KS. Usp18 Expression in CD169+ Macrophages is Important for Strong Immune Response after Vaccination with VSV-EBOV. Vaccines (Basel). 2020 Mar 23;8(1):142. doi: 10.3390/vaccines8010142. PMID: 32210083; PMCID: PMC7157200. Friedrich et al
Huttner A, Agnandji ST, Engler O, Hooper JW, Kwilas S, Ricks K, Clements TL, Jonsdottir HR, Nakka SS, Rothenberger S, Kremsner P, Züst R, Medaglini D, Ottenhoff T, Harandi AM, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Antibody responses to recombinant vesicular stomatitis virus-Zaire Ebolavirus vaccination for Ebola virus disease across doses and continents: 5-year durability. Clin Microbiol Infect. 2023 Dec;29(12):1587-1594. doi: 10.1016/j.cmi.2023.08.026. Epub 2023 Sep 3. PMID: 37661067. Huttner et al