{"id":5278,"date":"2022-02-10T16:48:11","date_gmt":"2022-02-10T14:48:11","guid":{"rendered":"https:\/\/www.msd.ch\/fr\/?page_id=5278"},"modified":"2024-02-08T11:57:48","modified_gmt":"2024-02-08T09:57:48","slug":"ervebo-publication-of-clinical-trial-results","status":"publish","type":"page","link":"https:\/\/www.msd.ch\/fr\/ervebo-publication-of-clinical-trial-results\/","title":{"rendered":"Ervebo – Ver\u00f6ffentlichung der Ergebnisse klinischer Versuche"},"content":{"rendered":"\n

Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques<\/h1>\n\n\n\n

Les informations ci-dessous ainsi que les liens correspondant aux donn\u00e9es cliniques r\u00e9pondent aux exigences des articles 71 \u00e0 73 de l\u2019Ordonnance sur les m\u00e9dicaments (Ordonnance sur les m\u00e9dicaments, OM\u00e9d) et compl\u00e8tent les informations publi\u00e9es en lien avec l\u2019autorisation suisse des m\u00e9dicaments correspondants.<\/p>\n\n\n\n

ERVEBO\u00ae<\/h2>\n\n\n\n

Vaccin contre Ebola Za\u00efre (rVSV\u0394G-ZEBOV-GP, vivant), Solution injectable<\/p>\n\n\n\n

Une dose (1 ml) contient: Vaccin Ebola Za\u00efre (rVSV\u0394G-ZEBOV-GP1,2<\/sup> vivant, att\u00e9nu\u00e9) \u226572 millions d’ufp3<\/sup><\/p>\n\n\n\n

1<\/sup> Virus de la stomatite v\u00e9siculaire recombinant (rVSV) souche Indiana avec une d\u00e9l\u00e9tion de la glycoprot\u00e9ine (G) d’enveloppe du VSV remplac\u00e9e par la glycoprot\u00e9ine (GP) de surface du virus Ebola Za\u00efre (ZEBOV) souche Kikwit 1995.
2<\/sup> Produit sur cellules Vero
3<\/sup> ufp = unit\u00e9s formant plage<\/p>\n\n\n\n

Num\u00e9ro d\u2019autorisation: 68358 <\/p>\n\n\n\n

Swissmedic Date d’autorisation: 10 novembre 2021<\/p>\n\n\n\n


\u00c9tudes cliniques<\/strong><\/strong><\/h4>\n\n\n\n

Protocol 009 (P009)<\/h4>\n\n\n\n

Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) – ClinicalTrials.gov<\/a>
NCT02344407 – P009<\/p>\n\n\n\n

Publications:<\/strong>
Kennedy SB, Bolay F, Kieh M, Grandits G, Badio M, Ballou R, Eckes R, Feinberg M, Follmann D, Grund B, Gupta S, Hensley L, Higgs E, Janosko K, Johnson M, Kateh F, Logue J, Marchand J, Monath T, Nason M, Nyenswah T, Roman F, Stavale E, Wolfson J, Neaton JD, Lane HC; PREVAIL I Study Group. Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia. N Engl J Med. 2017 Oct 12;377(15):1438-1447. doi: 10.1056\/NEJMoa1614067. PMID: 29020589; PMCID: PMC5705229.<\/p>\n\n\n\n

Higgs ES, Dubey SA, Coller BAG, Simon JK, Bollinger L, Sorenson RA, Wilson B, Nason MC, Hensley LE. Accelerating Vaccine Development During the 2013-2016 West African Ebola Virus Disease Outbreak. Curr Top Microbiol Immunol. 2017;411:229-261. doi: 10.1007\/82_2017_53. PMID: 28918539.<\/p>\n\n\n\n

Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016\/j.vaccine.2017.05.097. Epub 2017 Jun 21. PMID: 28647166.<\/p>\n\n\n\n

Grais RF, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller B, Welebob C, Hanson ME, Simon JK. Estimation of the correlates of protection of the rVSV\u0394G-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2\/3 clinical trials. Lancet Microbe 2021; 2: e70\u201378
<\/p>\n\n\n\n

Protocol 010 (P010) and Protocol 018 (P018)<\/h4>\n\n\n\n

Registered with the Pan African Clinical Trials Registry http:\/\/www.pactr.org\/<\/a>,
number PACTR201503001057193 (P010: Part A, P018: Part B)<\/p>\n\n\n\n

Publications:<\/strong>
Henao-Restrepo AM, Camacho A, Longini IM et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing EVD: final results from the Guinea ring vaccination, open-label, cluster[1]randomized trial (Ebola \u00c7a Suffit!). Lancet 2017; 389:505-18.<\/p>\n\n\n\n

Henao-Restrepo AM, Longini IM, Egger M, et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomized trial. Lancet 2015; 386: 857\u201366.<\/p>\n\n\n\n

Ajelli M, Merler S, Fumanelli L, et al. Spatio-temporal dynamics of the Ebola epidemic in Guinea and implications for vaccination and disease elimination: a computational modeling analysis. BMC Med 2016; 14: 130.<\/p>\n\n\n\n

Ebola \u00e7a suffit ring vaccination trial consortium. The ring vaccination trial: A novel cluster randomized controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ. 2015;351:h3740<\/p>\n\n\n\n

Juan-Giner A, Tchaton M, Jemmy JP, Soumah A, Boum Y, Faga EM, Cisse M, Grais RF. Safety of the rVSV ZEBOV vaccine against Ebola Zaire among frontline workers in Guinea. Vaccine. 2019 Nov 15;37(48):7171-7177. doi: 10.1016\/j.vaccine.2018.09.009. Epub 2018 Sep 25. PMID: 30266489.<\/p>\n\n\n\n

Grantz KH, Claudot P, Kambala M, Kouyat\u00e9 M, Soumah A, Boum Y, Juan-Giner A, Jemmy JP, Cummings DAT, Grais RF. Factors influencing participation in an Ebola vaccine trial among front-line workers in Guinea. Vaccine. 2019 Nov 15;37(48):7165-7170. doi: 10.1016\/j.vaccine.2019.09.094. Epub 2019 Oct 14. PMID: 31623917.<\/p>\n\n\n\n

Boum Y, Juan-Giner A, Hitchings M, Soumah A, Strecker T, Sadjo M, Cuthbertson H, Hayes P, Tchaton M, Jemmy JP, Clarck C, King D, Faga EM, Becker S, Halis B, Gunnstein N, Carroll M, R\u00f8ttingen JA, Kond\u00e9 MK, Doumbia M, Henao-Restrepo AM, Kieny MP, Cisse M, Draguez B, Grais RF. Humoral and cellular immune response induced by rVSV\u0394G-ZEBOV-GP vaccine among frontline workers during the 2013-2016 West Africa Ebola outbreak in Guinea. Vaccine. 2020 Jun 26;38(31):4877-4884. doi: 10.1016\/j.vaccine.2020.04.066. Epub 2020 Jun 1. PMID: 32499066; PMCID: PMC7306162.<\/p>\n\n\n\n

Grais RF, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller B, Welebob C, Hanson ME, Simon JK. Estimation of the correlates of protection of the rVSV\u0394G-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2\/3 clinical trials. Lancet Microbe 2021; 2: e70\u201378
<\/p>\n\n\n\n

<\/p>\n\n\n\n

Protocol 011 (P011)<\/h4>\n\n\n\n

STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola) – ClinicalTrials.gov<\/a>
NCT02378753 – P011<\/p>\n\n\n\n

Publications:<\/strong>
Samai M, Seward JF, Goldstein ST, Mahon BE, Lisk DR, Widdowson MA, Jalloh MI, Schrag SJ, Idriss A, Carter RJ, Dawson P, Kargbo SAS, Leigh B, Bawoh M, Legardy-Williams J, Deen G, Carr W, Callis A, Lindblad R, Russell JBW, Petrie CR, Fombah AE, Kargbo B, McDonald W, Jarrett OD, Walker RE, Gargiullo P, Bash-Taqi D, Gibson L, Fofanah AB, Schuchat A; STRIVE Study Team. The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV\u2206G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak. J Infect Dis. 2018 May 18;217(suppl_1):S6-S15. doi: 10.1093\/infdis\/jiy020. Erratum in: J Infect Dis. 2018 Jul 2;218(3):508-507.<\/p>\n\n\n\n

Fombah AE, Goldstein ST, Jarrett OD, Jalloh MI, El-Khorazaty J, Lisk DR, Legardy-Williams J, Pratt DA, George PM, Russell JBW, Schrag SJ, Dawson P, Deen GF, Carr W, Lindblad R, James F, Bah MM, Yillia JF, Sandy JD, Turay PE, Conteh MA, Slutsker L, Mahon BE, Samai M, Seward JF. Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE). J Infect Dis. 2018 May 18;217(suppl_1):S75-S80. doi: 10.1093\/infdis\/jix603.<\/p>\n\n\n\n

Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016\/j.vaccine.2017.05.097. Epub 2017 Jun 21.<\/p>\n\n\n\n

Legardy-Williams JK, Carter RJ, Goldstein ST, Jarrett OD, Szefer E, Fombah AE, Tinker SC, Samai M, Mahon BE. Pregnancy Outcomes among Women Receiving rVSV\u0394-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola. Emerg Infect Dis. 2020 Mar;26(3):541-548. doi: 10.3201\/eid2603.191018. Epub 2020 Mar 17. PMID: 32017677; PMCID: PMC7045819.<\/p>\n\n\n\n

Mahon BE, Simon J, Widdowson MA, Samai M, Rogier E, Legardy-Williams J, Liu K, Schiffer J, Lange J, DeByle C, Pinner R, Schuchat A, Slutsker L, Goldstein S. Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein. J Infect Dis. 2021 Dec 1;224(11):1907-1915. doi: 10.1093\/infdis\/jiab243. PMID: 34013349; PMCID: PMC8643414.<\/p>\n\n\n\n

Widdowson MA, Schrag SJ, Carter RJ, Carr W, Legardy-Williams J, Gibson L, Lisk DR, Jalloh MI, Bash-Taqi DA, Kargbo SA, Idriss A, Deen GF, Russell JB, McDonald W, Albert AP, Basket M, Callis A, Carter VM, Ogunsanya KR, Gee J, Pinner R, Mahon BE, Goldstein ST, Seward JF, Samai M, Schuchat A. Implementing an Ebola Vaccine Study – Sierra Leone. MMWR Suppl. 2016 Jul 8;65(3):98-106. doi: 10.15585\/mmwr.su6503a14. PMID: 27387395.<\/p>\n\n\n\n

Conteh MA, Goldstein ST, Wurie HR, Gidudu J, Lisk DR, Carter RJ, Seward JF, Hampton LM, Wang D, Andersen LE, Arvay M, Schrag SJ, Dawson P, Fombah AE, Petrie CR, Feikin DR, Russell JBW, Lindblad R, Kargbo SAS, Samai M, Mahon BE. Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola. J Infect Dis. 2018 May 18;217(suppl_1):S33-S39. doi: 10.1093\/infdis\/jiy061. PMID: 29788347; PMCID: PMC6927893.<\/p>\n\n\n\n

Grais RF, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller B, Welebob C, Hanson ME, Simon JK. Estimation of the correlates of protection of the rVSV\u0394G-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2\/3 clinical trials. Lancet Microbe 2021; 2: e70\u201378
<\/p>\n\n\n\n

Protocol 012 (P012)<\/h4>\n\n\n\n

Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012) – ClinicalTrials.gov<\/a>
NCT02503202 – P012<\/p>\n\n\n\n

Publications:<\/strong>
Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, Simon JK, Onorato MT, Liu K, Martin J, Helmond FA; V920-012 Study Team. Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi: 10.1093\/infdis\/jix189.<\/p>\n\n\n\n

Halperin SA, Das R, Onorato MT, Liu K, Martin J, Grant-Klein RJ, Nichols R, Coller BA, Helmond FA, Simon JK; V920-012 Study Team. Immunogenicity, Lot Consistency, and Extended Safety of rVSV\u0394G-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093\/infdis\/jiz241.<\/p>\n\n\n\n

Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016\/j.vaccine.2017.05.097. Epub 2017 Jun 21.<\/p>\n\n\n\n

CH-EBO-00001, 01\/2024<\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"

Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques Les informations ci-dessous ainsi que les liens correspondant aux donn\u00e9es cliniques r\u00e9pondent aux exigences des articles 71 \u00e0 73 de l\u2019Ordonnance sur les m\u00e9dicaments (Ordonnance sur les m\u00e9dicaments, OM\u00e9d) et compl\u00e8tent les informations publi\u00e9es en lien avec l\u2019autorisation suisse des m\u00e9dicaments correspondants. 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