Vaccines to prevent Ebola virus disease: current challenges and perspectives
- Authors: Kovyrshina A.V.1, Sizikova T.E.2, Lebedev V.N.2, Borisevich S.V.2, Dolzhikova I.V.1, Logunov D.Y.1, Gintsburg A.L.1
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Affiliations:
- National Research Centre for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
- 48 Central Scientific Research Institute of the Ministry of Defence of the Russian Federation
- Issue: Vol 68, No 5 (2023)
- Pages: 372-384
- Section: REVIEWS
- URL: https://journals.rcsi.science/0507-4088/article/view/231857
- DOI: https://doi.org/10.36233/0507-4088-193
- EDN: https://elibrary.ru/euauhi
- ID: 231857
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Abstract
Relevance. Ebola virus disease (EVD) is an acute infectious disease with an extremely high case fatality rate reaching up to 90%. EVD has become widely known since 2014–2016, when outbreak in West Africa occurred and led to epidemic, which caused travel-related cases on the territory of other continents.
There are two vaccines against EVD, prequalified by WHO for emergency use, as well as a number of vaccines, approved by local regulators in certain countries. However, even with the availability of effective vaccines, the lack of data on immune correlates of protection and duration of protective immune response in humans and primates is limiting factor for effectively preventing the spread of EVD outbreaks.
Aims. This review highlights experience of use of EVD vaccines during outbreaks in endemic areas, summarizes data on vaccine immunogenicity in clinical trials, and discusses perspectives for further development and use of effective EVD vaccines.
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##article.viewOnOriginalSite##About the authors
Anna V. Kovyrshina
National Research Centre for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
Author for correspondence.
Email: kovyrshina@gamaleya.org
ORCID iD: 0000-0002-8757-7026
junior researcher
Russian Federation, 123098, MoscowTatiana E. Sizikova
48 Central Scientific Research Institute of the Ministry of Defence of the Russian Federation
Email: sizikovate@mail.ru
ORCID iD: 0000-0002-1817-0126
PhD, senior researcher
Russian Federation, 141306, Sergiev PosadVitaliy N. Lebedev
48 Central Scientific Research Institute of the Ministry of Defence of the Russian Federation
Email: 48cnii@mil.ru
ORCID iD: 0000-0002-6552-4599
DSc, professor, leading researcher
Russian Federation, 141306, Sergiev PosadSergey V. Borisevich
48 Central Scientific Research Institute of the Ministry of Defence of the Russian Federation
Email: 48cnii@mil.ru
ORCID iD: 0000-0002-6742-3919
DSc, professor, academician of RAS, head of the institute
Russian Federation, 141306, Sergiev PosadInna V. Dolzhikova
National Research Centre for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
Email: dolzhikova@gamaleya.org
ORCID iD: 0000-0003-2548-6142
PhD, leading researcher, head of State virus collection laboratory
Russian Federation, 123098, MoscowDenis Yu. Logunov
National Research Centre for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
Email: logunov@gamaleya.org
ORCID iD: 0000-0003-4035-6581
DSc, academician of RAS, chief researcher, deputy director for research, head of laboratory of cell microbiology
Russian Federation, 123098, MoscowAlexander L. Gintsburg
National Research Centre for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
Email: gintsburg@gamaleya.org
ORCID iD: 0000-0003-1769-5059
DSc, professor, academician of RAS, director
Russian Federation, 123098, MoscowReferences
- Biedenkopf N., Bukreyev A., Chandran K., Di Paola N., Formenty P.B.H., Griffiths A., et al. Renaming of genera Ebolavirus and Marburgvirus to Orthoebolavirus and Orthomarburgvirus, respectively, and introduction of binomial species names within family Filoviridae. Arch. Virol. 2023; 168(8): 220. https://doi.org/10.1007/s00705-023-05834-2
- Sharma A.R., Lee Y.H., Nath S., Lee S.S. Recent developments and strategies of Ebola virus vaccines. Curr. Opin. Pharmacol. 2021; 60: 46–53. https://doi.org/10.1016/j.coph.2021.06.008
- Regules J.A., Beigel J.H., Paolino K.M., Voell J., Casellano A.R., Munoz P., et al. A recombinant vesicular stomatitis virus Ebola vaccine. N. Engl. J. Med. 2017; 376(4): 330–41. https://doi.org/10.1056/NEJMoa1414216
- Henao-Restrepo A.M., Camacho A., Longini I.M., Watson C.H., Edmunds W.J., Egger M., et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: Final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola ÇaSuffit!). Lancet. 2017; 389(10068): 505–18. https://doi.org/10.1016/S0140-6736(16)32621-6
- Gsell P.S., Camacho A., Kucharski A.J., Watson C.H., Bagayoko A., Nadlaou S.D., et al. Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report. Lancet Infect. Dis. 2017; 17(12): 1276–84. https://doi.org/10.1016/s1473-3099(17)30541-8
- Simon J.K., Kennedy S.B., Mahon B.E., Dubey S.A., Grant-Klein R.J., Liu K., et al. Immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine (ERVEBO®) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials. Vaccine. 2022; 40(46): 6599–606. https://doi.org/10.1016/j.vaccine.2022.09.037
- Hoff N.A., Bratcher A., Kelly J.D., Musene K., Kompany J.P., Kabamba M., et al. Immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccination in exposed and potentially exposed persons in the Democratic Republic of the Congo. Proc. NatlAcad. Sci. USA. 2022; 119(6): e2118895119. https://doi.org/10.1073/pnas.2118895119
- Agnandji S., Huttrier A., Zinser M., Njuguna P., Dahlike C., Fernandes J., et al. Phase I trials of rVSV Ebola vaccine in Africa and Europe – Preliminary report. N. Engl. J. Med. 2016; 374(17): 1647–60. https://doi.org/10.1056/NEJMoa1502924
- Huttner A., Dayer J.A., Yerly S., Combescure C., Auderset F., Desmeules J., et al. VSV-Ebola Consortium. The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. Lancet Infect. Dis. 2015; 15(10): 1156–66. https://doi.org/10.1016/S1473-3099(15)00154-1
- Ishola D., Manno D., Afolabi M.O., Keshinro B., Bockstal V., Rogers B., et al. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial. Lancet Infect. Dis. 2022; 22(1): 97–109. https://doi.org/10.1016/S1473-3099(21)00125-0
- Pollard A.J., Launay O., Lelievre J.D., Lacabaratz C., Grande S., Goldstein N., et al. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect. Dis. 2021; 21(4): 493–506. https://doi.org/10.1016/S1473-3099(20)30476-X
- Afolabi M.O., Ishola D., Manno D., Keshinro B., Bockstal V., Rogers B., et al. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial. Lancet Infect. Dis. 2021; 22(1): 110–22. https://doi.org/10.1016/S1473-3099(21)00128-6
- Zhu F.C., Hou L.H., Li J.X., Wu S.P., Liu P., Zhang G.R., et al. Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomized, double-blind, placebo-controlled, phase I trial. Lancet. 2015; 385(9984): 2272–9. https://doi.org/10.1016/s0140-6736(15)60553-0
- Zhu F.C., Wurie A.H., Hou L.H., Liang Q., Li Y.H., Russell J.B., et al. Safety and immunogenicity of a recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in Sierra Leone: A single-centre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017; 389(10069): 621–8. https://doi.org/10.1016/S0140-6736(16)32617-4
- Li J.X., Hou L.H., Meng F.Y., Wu S.P., Hu Y.M., Liang Q., et al. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase I trial. Lancet Glob. Health. 2017; 5(3): e324–34. https://doi.org/10.1016/S2214-109X(16)30367-9
- Ersching J., Hernandez M.I., Cezarotto F.S., Ferreira J.D., Martins A.B., Switzer W.M., et al. Neutralizing antibodies to human and simian adenoviruses in humans and New-World monkeys. Virology. 2010; 407(1): 1–6. https://doi.org/10.1016/j.virol.2010.07.043
- Dolzhikova I.V., Tokarskaya E.A., Dzharullaeva A.S., Tukhvatulin A.I., Shcheblyakov D.V., Voronina O.L., et al. Virus-vectored Ebola vaccines. Acta Naturae. 2017; 9(3): 4–11.
- Dolzhikova I.V., Zubkova O.V., Tukhvatulin A.I., Dzharullaeva A.S., Tukhvatulina N.M., Shcheblyakov D.V., et al. Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia. Hum. Vaccines Immunother. 2017; 13(3): 613–20. https://doi.org/10.1080/21645515.2016.1238535
- Ryzhikov A.B., P’yankov O.V., Danilenko E.D., Gamaley S.G., Shimina G.G., Sysoeva G.M., et al. Preclinical evaluation of Ebola Vaccine EpiVacEbola: Immunogenicity and safety results. In: Materials of the XI Congress of the All-Russian Scientific and Practical Society of Epidemiologists, Microbiologists and Parasitologists «Ensuring epidemiological well-being: challenges and solutions» [Materialy XI s”ezdaVserossiyskogonauchno-prakticheskogoobshchestvaepidemiologov, mikrobiologoviparazitologov «Obespechenieepidemiologicheskogoblagopoluchiya: vyzovyiresheniya»]. St. Petersburg; 2017. https://elibrary.ru/zwaqtr (in Russian)
- Ewer K., Rampling T., Venkatraman N., Bowyer G., Wright D., Lambe T., et al. A monovalent chimpanzee adenovirus Ebola vaccine boosted with MVA. N. Engl. J. Med. 2016; 374(17): 1635–46. https://doi.org/10.1056/NEJMoa1411627
- Tapia M.D., Sow S.O., Lyke K.E., Haidara F.C., Diallo F., Doumbia M., et al. 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. Lancet Infect. Dis. 2016; 16(1): 31–42. https://doi.org/10.1016/S1473-3099(15)00362-X
- Venkatraman N., Ndiaye B.P., Bowyer G., Wade D., Sridhar S., Wright D., et al. Safety and immunogenicity of a heterologous prime-boost Ebola virus vaccine regimen in healthy adults in the United Kingdom and Senegal. J. Infect. Dis. 2019; 219(8): 1187–97. https://doi.org/10.1093/infdis/jiy639
- Tapia M.D., Sow S.O., Ndiaye B.P., Mbaye K.D., Thiongane A., Ndour C.T., et al. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect. Dis. 2020; 20(6): 707–18. https://doi.org/10.1016/S1473-3099(20)30016-5
- Tapia M.D., Sow S.O., Mbaye K.D., Thiongane A., Ndiaye B.P., Ndour C.T., et al. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2020; 20(6): 719–30. https://doi.org/10.1016/S1473-3099(20)30019-0
- Clarke D.K., Xu R., Matassov D., Latham T.E., Ota-Setlik A., Gerardi C.S., et al. Safety and immunogenicity of a highly attenuated rVSVN4CT1-EBOVGP1 Ebola virus vaccine: a randomised, double-blind, placebo-controlled, phase 1 clinical trial. Lancet Infect. Dis. 2020; 20(4): 455–66. https://doi.org/10.1016/S1473-3099(19)30614-0
- Fries L., Cho I., Krähling V., Fehling S.K., Strecker T., Becker S., et al. Randomized, blinded, dose-ranging trial of an Ebola virus glycoprotein nanoparticle vaccine with Matrix-M adjuvant in healthy adults. J. Infect. Dis. 2020; 222(4): 572–82. https://doi.org/10.1093/infdis/jiz518
- Martin J.E., Sullivan N.J., Enama M.E., Gordon I.J., Roederer M., Koup R.A., et al. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin. Vaccine Immunol. 2006; 13(11): 1267–77. https://doi.org/10.1128/cvi.00162-06
- Kibuuka H., Berkowitz N.M., Millard M., Enama M.E., Tindikahwa A., Sekiziyivu A.B., et al. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: A phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015; 385(9977): 1545–54. https://doi.org/10.1016/S0140-6736(14)62385-0
- Schieffelin J.S. An effective and safe vaccine will not be enough to prepare us for the next Ebola outbreak. Lancet Infect. Dis. 2017; 17(12): 1224–25. https://doi.org/10.1016/S1473-3099(17)30575-3
- Bockstal V., Leyssen M., Heerwegh D., Spiessens B., Robinson C., Stoop J.N., et al. Non-human primate to human immunobridging demonstrates a protective effect of Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola. NPJ Vaccines. 2022; 7(1): 156. https://doi.org/10.1038/s41541-022-00564-z
- Feldmann H., Feldmann F., Marzi A. Ebola: lessons on vaccine development. Annu. Rev. Microbiol. 2018; 72: 423–46. https://doi.org/10.1146/annurev-micro-090817-062414
- Agnandji S.T., Fernandes J.F., Bache E.B., Obiang Mba R.M., Brosnahan J.S., Kabwende L., et al. Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: a phase I randomised trial. PLoS Med. 2017; 14(10): e1002402. https://doi.org/10.1371/journal.pmed.1002402
- Henao-Restrepo A.M., Longini I.M., Egger M., Dean N.E., Edmunds W.J., Camacho A., et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial. Lancet. 2015; 386(9996): 857–66. https://doi.org/10.1016/s0140-6736(15)61117-5
- Bockstal V., Shukarev G., McLean C., Goldstein N., Bart S., Gaddah A., et al. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study. PLoS One. 2022; 17(10): e0274906. https://doi.org/10.1371/journal.pone.0274906
- Milligan I.D., Gibani M.M., Sewell R., Clutterbuck E.A., Campbell D., Plested E., et al. Safety and immunogenicity of novel adenovirus type 26- and modified vaccinia Ankara-vectored Ebola vaccines: a randomized clinical trial. JAMA. 2016; 315(15): 1610–23. https://doi.org/10.1001/jama.2016.4218
- specific antibodies; EU/ml – ELISA units/ml in commercial test kits.